Correlates of fruit and vegetable intake among parents and adolescents: findings from the Family Life, Activity, Sun, Health, and Eating (FLASHE) study.

OBJECTIVE: The present study aimed to examine the correlates of fruit and vegetable intake (FVI) separately among parents and their adolescents. DESIGN: Cross-sectional surveys. SETTING: Online survey. SUBJECTS: Parents and adolescents completed the Family Life, Activity, Sun, Health, and Eating (FLASHE) survey through the National Cancer Institute. The survey assessed daily intake frequencies of food/beverage groups, psychosocial, parenting and sociodemographic factors. Generalized linear models were run for both parents and adolescents, for a total of six models (three each): (i) sociodemographic characteristics; (ii) psychosocial factors; (iii) parent/caregiver factors. RESULTS: Parent participants (n 1542) were predominantly 35-59 years old (86 %), female (73 %), non-Hispanic White (71 %) or non-Hispanic Black (17 %), with household income <$US 100 000 (79 %). Adolescents (n 805) were aged 12-14 years (50 %), non-Hispanic White (66 %) and non-Hispanic Black (15 %). Parents consumed 2·9 cups fruits and vegetables (F&V) daily, while adolescents consumed 2·2 cups daily. Educational attainment (higher education had greater FVI) and sex (men consumed more than women; all P<0·001) were significant FVI predictors. Parents with greater autonomous and controlled motivation, self-efficacy and preferences for fruit reported higher FVI (all P<0·001). Similarly, adolescents with greater autonomous and controlled motivation, self-efficacy and knowledge reported higher FVI (all P<0·001). Parenting factors of importance were co-deciding how many F&V teens should have, rules, having F&V in the home and cooking meals from scratch (all P<0·05). CONCLUSIONS: Findings suggest factors that impact FVI among parents and their adolescent(s), which highlight the importance of the role of parent behaviour and can inform tailored approaches for increasing FVI in various settings.

Technical Assistance and Changes in Nutrition and Physical Activity Practices in the National Early Care and Education Learning Collaboratives Project, 2015-2016.

PURPOSE AND OBJECTIVES: The National Early Care and Education Learning Collaboratives Project (ECELC) aims to improve best practices in early care and education (ECE) programs in topic areas of the Nutrition and Physical Activity Self-Assessment in Child Care (NAP SACC). Technical assistance is a component of the ECELC, yet its effect on outcomes is unclear. Beyond dose and duration of technical assistance, limited research exists on characteristics of technical assistance that contribute to outcomes. The objective of this study was to identify and describe technical assistance characteristics and explore associations with NAP SACC outcomes. INTERVENTION APPROACH: We collected data from 10 collaboratives comprising 84 ECE programs in 2 states in 2015-2016. The objective of technical assistance was to support programs in improving best practices. Technical assistance was provided to programs via on-site, telephone, or email and was tailored to program needs. EVALUATION METHODS: We used a mixed-methods design to examine associations between technical assistance and NAP SACC outcomes. We used multiple regression analysis to assess quantitative data and qualitative comparative analysis to determine necessary and sufficient technical assistance conditions supporting NAP SACC outcomes. We also conducted a document review to describe technical assistance that referred conditions identified by the qualitative comparative analysis. RESULTS: Regression analyses detected an inverse relationship between changes in NAP SACC scores and hours of technical assistance. No clear pattern emerged in the qualitative comparative analysis, leaving no necessary and sufficient conditions. However, the qualitative comparative analysis identified feedback as a potentially important component of technical assistance, whereas resource sharing and frequent email were characteristics that seemed to reduce the likelihood of improved outcomes. Email and resource sharing were considered primarily general information rather than tailored technical assistance. IMPLICATIONS FOR PUBLIC HEALTH: Technical assistance may be used in programs and made adaptable to program needs. The inclusion and evaluation of technical assistance, especially tailored approaches, is warranted for environmental interventions, including ECE settings.

Feasibility of Using a Community-Supported Agriculture Program to Increase Access to and Intake of Vegetables among Federally Qualified Health Center Patients.

OBJECTIVE: This study explored the feasibility of using a 23-week subsidized community-supported agriculture program to increase access to and intake of vegetables among Federally Qualified Health Center patients. METHODS: Outcomes were measured using pre-post intervention surveys (n = 9). Process data were collected in post-intervention surveys and focus groups (n = 15). RESULTS: Most participants (77%) indicated that the program improved their health and all (100%) reported that they were eating a greater variety of vegetables because of their participation in the program. Three themes emerged from the focus groups: increased access to fresh and/or organic vegetables, improved diet quality, and the importance of social support during the program. CONCLUSIONS AND IMPLICATIONS: Linking subsided community-supported agriculture programs with Federally Qualified Health Centers has the potential to increase access to and intake of vegetables among low-income patients. However, further research is needed with a larger sample size and a more robust study design.

Meals for Good: An innovative community project to provide healthy meals to children in early care and education programs through food bank catering.

Innovative approaches to childhood obesity prevention are warranted in early care and education (ECE) settings, since intervening early among youth is recommended to promote and maintain healthy behaviors. The objective of the Meals for Good pilot was to explore feasibility of implementing a food bank-based catering model to ECE programs to provide more nutritious meals, compared to meals brought from home (a parent-prepared model). In 2014-2015, a 12-month project was implemented by a food bank in central Florida in four privately-owned ECE programs. An explanatory sequential design of a mixed-methods evaluation approach was utilized, including a pre-post menu analysis comparing parent-prepared meals to the catered meals, and stakeholder interviews to determine benefits and barriers. The menu analysis of lunches showed daily reductions in calories, fat, and saturated fat, but an increase in sodium in catered meals when compared to parent-prepared meals. Interviews with ECE directors, teachers, parents, and food bank project staff, identified several benefits of the catered meals, including healthfulness of meals, convenience to parents, and the ECE program's ability to market this meal service. Barriers of the catered meals included the increased cost to parents, transportation and delivery logistics, and change from a 5 to a 2-week menu cycle during summer food service. This pilot demonstrated potential feasibility of a food bank-ECE program partnership, by capitalizing on the food bank's existing facilities and culinary programming, and interest in implementing strategies focused on younger children. The food bank has since leveraged lessons learned and expanded to additional ECE programs.

Improving Nutrition and Physical Activity Policies and Practices in Early Care and Education in Three States, 2014-2016.

The National Early Care and Education Learning Collaboratives (ECELC) project aims to facilitate best practices in nutrition, physical activity, screen time, and breastfeeding support and infant feeding among early care and education (ECE) programs across multiple states. The project uses a train-the-trainer approach with 5, in-person learning-collaborative sessions, technical assistance, and action planning. We describe the longitudinal practice-based evaluation of the project and assess whether ECE programs evaluated (n = 104) sustained changes in policies and practices 1 year after completing the project. The number of best practices increased from pre-assessment to post-assessment (P < .01) but did not change significantly from post-assessment to follow-up assessment. ECELC shows promise as an approach to incorporate professional development and training focused on improving best practices for environment-level child nutrition and physical activity, which is one strategy among many that are warranted for obesity prevention in young children.

Using Secondary 24-Hour Dietary Recall Data to Estimate Daily Dietary Factor Intake From the FLASHE Study Dietary Screener.

INTRODUCTION: The National Cancer Institute's 2014 Family Life, Activity, Sun, Health, and Eating Study utilized a 27-item Dietary Screener tailored to adolescent eating patterns that assessed the frequency of intake of several foods and beverages in parent-adolescent dyads. This study estimated intake of fruits and vegetables (FVs), dairy, added sugars, and whole grains for screener respondents using existing, nationally representative, 24-hour dietary recall data. METHODS: Dietary Screener items were converted from frequency responses to daily intake. Intake (dependent variable) was estimated using regression coefficients and portion sizes of foods and beverages (independent variables) generated from the 2003-2006 National Health and Nutrition Examination Survey 2-day 24-hour recall data set. Means (SDs) were used to examine daily dietary factor intake among parent and adolescents. Analysis was conducted in 2015-2016. The analytic sample consisted of 1,732 parents (aged ≥18 years) and their adolescent aged 12-17 years (n=1,632). RESULTS: Male parents consumed 3.6 cups of FVs, 1.8 cups of dairy, 22.6 teaspoons of added sugars, and 2.1 ounces of whole grains daily; female parents consumed 2.8 cups of FVs, 1.3 cups of dairy, 14.8 teaspoons of added sugars, and 1.4 ounces of whole grains daily. Male adolescents consumed 2.2 cups of FVs, 1.9 cups of dairy, 17.9 teaspoons of added sugars, and 1.0 ounces of whole grains daily; female adolescents consumed 2.2 cups FVs, 1.6 cups of dairy, 14.2 teaspoons of added sugars, and 0.8 ounces of whole grains daily. CONCLUSIONS: Utilizing a dietary screener tailored to adolescent eating patterns in parent-adolescent dyads provided estimated dietary factor intake, underscoring existing 24-hour dietary recall data can be used to calibrate dietary habits.

Assessment of nutrition and physical activity practices using self-report and observation in early care and education across multiple US states.

OBJECTIVE: The National Early Care and Education Learning Collaboratives (ECELC) Project aims to promote healthy physical activity and nutrition environments, policies and practices in early care and education (ECE) programmes across multiple states. The present pilot study sought to assess changes to the physical activity and nutrition practices in a sub-sample of ECE programmes participating in the ECELC using the Environment and Policy Assessment and Observation (EPAO). Additionally, it sought to compare results with the Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC). DESIGN: Quasi-experimental pre-post pilot study where paired-sample t tests examined changes to physical activity and nutrition practices from pre-assessment to post-assessment (P<0·05). Pearson correlation coefficients examined change scores from EPAO compared with NAP SACC with statistical significance set at a two-sided α level of P<0·10 to account for sample size. SETTING: The study occurred among ECE programmes. SUBJECTS: Pre-school classrooms in nineteen ECE programmes across four US states were observed. RESULTS: EPAO data demonstrated an increase in total score from pre-assessment to post-assessment (150 (sd 30) to 176 (sd 35)). NAP SACC change scores demonstrated little relationship with EPAO domain change scores, with exceptions in Nutrition Policy and Physical Activity Policy (r=-0·4 and -0·6, respectively). CONCLUSIONS: The overall improvements reported through the EPAO suggest participation in the ECELC resulted in changes in critical nutrition- and physical activity-related practices. However, considerable differences in data reported using the NAP SACC compared with the EPAO suggest subjective data should be interpreted with caution and objective measurement should be used when feasible.

The Future of the Small Rural Grocery Store: A Qualitative Exploration.

OBJECTIVES: Rural communities face unique challenges to and opportunities for offering more healthful foods and are often understudied in comparison to their urban counterparts. The purpose of this study was to conduct a qualitative assessment of rural storeowners' perceptions of their communities, their business practices, and factors that influences their viability, sustainability, and ability to support healthy food choices. METHODS: We conducted interviews with storeowners (N = 15) in small stores in rural Nebraska and explored perceptions of business practices, role in the community, and consumer demand for more healthful foods. RESULTS: The storeowners reported strategies they employ to remain competitive, such as selling alcohol and tobacco, focusing on customer service, and ensuring quality of products. Manufacturer and distributor agreements often put constraints on their business models. Key challenges reported included a dwindling population and competition with larger chains in neighboring towns set in a sparsely populated landscape. Goals for the future included expanding equipment, largely to offer more prepared foods. CONCLUSIONS: This study adds to the literature around food access in rural communities, and can inform future implementation strategies to work with storeowners to improve healthy food access.

Snack Food, Satiety, and Weight.

In today's society, snacking contributes close to one-third of daily energy intake, with many snacks consisting of energy-dense and nutrient-poor foods. Choices made with regard to snacking are affected by a multitude of factors on individual, social, and environmental levels. Social norms, for example, that emphasize healthful eating are likely to increase the intake of nutrient-rich snacks. In addition, satiety, the feeling of fullness that persists after eating, is an important factor in suppressing overconsumption, which can lead to overweight and obesity. Thus, eating snacks between meals has the potential to promote satiety and suppress overconsumption at the subsequent meal. Numerous studies have explored the relation between snack foods and satiety. These studies concluded that whole foods high in protein, fiber, and whole grains (e.g., nuts, yogurt, prunes, and popcorn) enhance satiety when consumed as snacks. Other foods that are processed to include protein, fiber, or complex carbohydrates might also facilitate satiety when consumed as snacks. However, studies that examined the effects of snack foods on obesity did not always account for satiety and the dietary quality and portion size of the snacks consumed. Thus, the evidence concerning the effects of snack foods on obesity has been mixed, with a number of interventional and observational studies not finding a link between snack foods and increased weight status. Although further prospective studies are warranted to conclusively determine the effects of snack foods on obesity risk, the consumption of healthful snacks likely affects satiety and promotes appetite control, which could reduce obesity.

Auxiliary measures to assess factors related to food insecurity: Preliminary testing and baseline characteristics of newly designed hunger-coping scales.

The objective of this paper is to describe the development and preliminary testing of new scales to assess hunger-coping behaviors in a very low-income population. Very low-income adults (≥ 19 years), caregivers to at least one child (n = 306) completed a survey in a community setting (e.g., libraries). The survey included novel items assessing hunger-coping behaviors (e.g., trade-offs to purchase food, strategies to stretch and obtain food), food insecurity status, and physiological hunger. Internal consistency of hunger-coping scales, one-way ANOVAs, post-hoc analyses, Spearman's correlations among variables. Respondents were 75% female, 51% African American, 34% White, and 15% Hispanic, and 73% earned <$20,000/year. Four scales emerged: hunger-coping trade-offs, financial coping strategies, rationing coping strategies, and physiological adult hunger symptoms. All scales demonstrated acceptable internal consistency (α/KR-20 = 0.70-0.90). Predictive, construct, and content validity were demonstrated by correlations between hunger-coping scales and food insecurity (FI), measured with the USDA 6-item HFSSM (rs = 0.42-0.68, ps < 0.001). Higher levels of hunger-coping trade-offs (F(2,297) = 42.54, p < 0.001), financial coping strategies (F(2,287) = 70.77, p < 0.001), and rationing coping strategies (F(2,284) = 69.19, p < 0.001), corresponded with increasing levels of FI. These preliminary results support use of newly developed hunger-coping scales in a very low-income population and can compliment traditional food security measures to inform hunger prevention policy and programming.

Household food insecurity as a determinant of overweight and obesity among low-income Hispanic subgroups: Data from the 2011-2012 California Health Interview Survey.

An estimated 78% of Hispanics in the United States (US) are overweight or obese. Household food insecurity, a condition of limited or uncertain access to adequate food, has been associated with obesity rates among Hispanic adults in the US. However, the Hispanic group is multi-ethnic and therefore associations between obesity and food insecurity may not be constant across Hispanic country of origin subgroups. This study sought to determine if the association between obesity and food insecurity among Hispanics is modified by Hispanic ancestry across low-income (≤200% of poverty level) adults living in California. Data are from the cross-sectional 2011-12 California Health Interview Survey (n = 5498). Rates of overweight or obesity (BMI ≥ 25), Calfresh receipt (California's Supplemental Nutrition Assistance Program), and acculturation were examined for differences across subgroups. Weighted multiple logistic regressions examined if household food insecurity was significantly associated with overweight or obesity and modified by country of origin after controlling for age, education, marital status, country of birth (US vs. outside of US), language spoken at home, and Calfresh receipt (P < .05). Significant differences across subgroups existed for prevalence of overweight or obesity, food security, Calfresh receipt, country of birth, and language spoken at home. Results from the adjusted logistic regression models found that food insecurity was significantly associated with overweight or obesity among Mexican-American women (ß (SE) = 0.22 (0.09), p = .014), but not Mexican-American men or Non-Mexican groups, suggesting Hispanic subgroups behave differently in their association between food insecurity and obesity. By highlighting these factors, we can promote targeted obesity prevention interventions, which may contribute to more effective behavior change and reduced chronic disease risk in this population.

Factors influencing food preparation behaviours: findings from focus groups with Mexican-American mothers in southern California.

OBJECTIVE: The purpose of the present study was to explore food preparation behaviours, attitudes, meal planning and shopping among Mexican-American mothers. DESIGN: Data were collected through four focus groups with mothers of Mexican origin/ancestry who considered themselves to be the primary food preparer. Topics included food preparation behaviours and influencers (culture, family, attitudes, barriers, meal planning and shopping). Data were analysed using a qualitative grounded theory approach. All focus groups were audio recorded, transcribed verbatim and coded for themes. SETTING: Data were collected in southern California, USA in 2013. SUBJECTS: Of the sample of twenty-one Mexican-American mothers, thirteen were born outside the USA and the mean household size was five members. RESULTS: Participants reported that food was often prepared using traditional staples and food preparation behaviours were learned from maternal family members. Participants also suggested that health was influenced by foods eaten and how they were prepared. Salient factors influencing food preparation behaviours included culture and tradition, maternal family members' food preparation behaviours, food preparation self-efficacy and attitudes towards healthy eating. Time and busy schedules were cited as barriers. CONCLUSIONS: Future interventions should consider utilizing family-based approaches and teaching culturally relevant food preparation skills, especially to youth, while reinforcing more healthful dietary practices.

Development and Testing of a Revised Cooking Matters for Adults Survey.

OBJECTIVES: The purpose of this study was to: (1) develop and psychometrically test a survey designed to assess Cooking Matters for Adults (CMA); and (2) assess changes in outcomes from pre- to post-pilot testing in English-speaking CMA classes to support the construct validity of the survey. METHODS: Cognitive interviewing participants were drawn from a low-income convenience sample in Omaha, Nebraska (N = 21). The survey included items to assess dietary patterns and choices, sociodemographics, and psychosocial correlates. Analyses were conducted with SPSS and included descriptive statistics, exploratory factor analysis, Cronbach's alpha, and paired sample t-tests. RESULTS: Cognitive interviewing resulted in changes to survey layout and wording. Factor analysis revealed 4 actors with Cronbach alphas supporting internal consistency. Between pretest and posttest, fruit intake increased (p < .05) and non-fried potatoes decreased (p < .05). Selection of healthy dietary options (low-fat dairy and milk, sodium, lean meats; p's < .05), healthy food preparation (p < .001), and cooking confidence (p < .001) increased and perceived barriers to cooking (p < .01) decreased. CONCLUSIONS: The CMA Survey includes psychometrically sound items and positive self-reported changes. This survey can be a valuable resource for other similar programs.

A workplace farmstand pilot programme in Omaha, Nebraska, USA.

OBJECTIVE: To explore the feasibility of a workplace farmstand programme through the utilization of an online ordering system to build awareness for local food systems, encourage community participation, and increase local fruit and vegetable availability. DESIGN: A 4-week pilot to explore feasibility of workplace farmstand programmes through a variety of outcome measures, including survey, mode of sale, weekly sales totals and intercept interviews. SETTING: A large private company in Sarpy County, Omaha, Nebraska, USA. SUBJECTS: Employees of the company hosting the farmstand programme. RESULTS: Pre-programme, a majority of employees indicated that quality (95·4 %), variety (94·6 %) and cost of fruits and vegetables (86·4 %) were driving factors in their fruit and vegetable selection when shopping. The availability of locally or regionally produced fruits and vegetables was highly important (78·1 %). Participants varied in their definition of local food, with nearly half (49·2 %) reporting within 80·5 km (50 miles), followed by 160·9 km (100 miles; 29·5 %) and 321·9 km (200 miles; 12·1 %). Weekly farmstand purchases (both walk-ups and online orders) ranged from twenty-eight to thirty-nine employees, with weekly sales ranging from $US 257·95 to 436·90 for the producer. The mode of purchase changed throughout the pilot, with higher use of online ordering in the beginning and higher use of walk-up purchasing at the end. CONCLUSIONS: The workplace farmstand pilot study revealed initial interest by both employees and a producer in this type of programme, helped to establish a sustained producer-employer relationship and led to additional opportunities for both the producer and employer.

Promoting influenza vaccination: insights from a qualitative meta-analysis of 14 years of influenza-related communications research by U.S. Centers for Disease Control and Prevention (CDC).

INTRODUCTION: A primary mission of the U.S. Centers for Disease Control and Prevention's (CDC) is promoting immunization against seasonal influenza. As with most education efforts, CDC's influenza-related communications are often informed by formative research. METHODS: A qualitative meta-analysis of 29 unpublished, primarily qualitative CDC-sponsored studies related to flu and flu vaccination knowledge, attitudes and beliefs (KABs). The studies, undertaken between 2000 and 2013, involved focus groups, in-depth interviews, message testing and surveys. Some involved health care professionals, while others involved members of the public, including sub-populations at risk for severe illness. FINDINGS: The themes that emerged suggested progress in terms of KABs related to influenza and influenza vaccination, but also the persistence of many barriers to vaccine acceptance. With respect to the public, recurring themes included limited understanding of influenza and immunization recommendations, indications of greater sub-group recognition of the value of flu vaccination, continued resistance to vaccination among many, and overestimation of the effectiveness of non-vaccine measures. Seven cognitive facilitators of vaccination were identified in the studies along with six cognitive barriers. For health care providers, the analysis suggests greater knowledge and more favorable beliefs, but many misperceptions persist and are similar to those held by the public. KABs often differed by type or category of health care provider. CONCLUSIONS: The themes identified in this qualitative analysis illustrate the difficulty in changing KABs related to influenza and influenza vaccine, particularly on the scope and scale needed to greatly improve uptake. Even with an influenza pandemic and more vaccine options available, public and some health care provider perceptions and beliefs are difficult and slow to change. This meta-analysis does, however, provide important insights from previously unpublished information that can help those who are promoting influenza vaccination to health care providers, the general public and specific populations within the general population.

Fruits and vegetables as a healthier snack throughout the day among families with older children: findings from a survey of parent-child dyads.

Most U.S. youth fail to eat the recommended amount of fruits and vegetables (FV) however many consume too many calories as added sugars and solid fats, often as snacks. The aim of this study was to assess factors associated with serving FV as snacks and with meals using parent-child dyads. A cross-sectional sample of U.S. children aged 9 to 18, and their caregiver/parent (n=1522) were part of a Consumer Panel of households for the 2008 YouthStyles mail survey. Chi-square test of independence and multivariable logistic regression were used to assess associations between serving patterns of FV as snacks with variations in serving patterns, and covariates including dietary habits. Most parents (72%) reported serving FV at meals and as snacks. Fruit was most frequently served as a snack during the day (52%) and vegetables were most frequently served as a snack during the day (22%) but rarely in the morning. Significant differences in child FV intake existed among FV as a snack serving patterns by parents. Compared to children whose parents served FV only at meals, children whose parents reported serving FV as snacks in addition to meals were significantly more likely to have consumed FV the day before (using a previous day screener), P<0.05. Contributing to the growing collection of literature describing parent-child dyad dietary behaviors, these findings suggest promoting FV access and intake throughout the day, not only at meals, by including serving as snacks, may increase FV intake among older children and adolescents.

Stakeholders' interest in and challenges to implementing farm-to-school programs, Douglas County, Nebraska, 2010-2011.

INTRODUCTION: Schools are uniquely positioned to influence the dietary habits of children, and farm-to-school programs can increase fruit and vegetable consumption among school-aged children. We assessed the feasibility of, interest in, and barriers to implementing farm-to-school activities in 7 school districts in Douglas County, Nebraska. METHODS: We used a preassessment and postassessment survey to obtain data from 3 stakeholder groups: school food service directors, local food producers, and food distributors. We had a full-time farm-to-school coordinator who was able to engage multiple stakeholders and oversee the development and dissemination of a toolkit. We used descriptive statistics to make comparisons. RESULTS: Seven food service directors, 5 distributors identified by the food service directors, and 57 local producers (9 completed only the preassessment survey, 16 completed only the postassessment survey, and 32 completed both) completed various components of the assessment. Interest in pursuing farm-to-school activities to incorporate more local foods in the school lunch program increased during the 2-year project; mean interest in purchasing local foods by food service directors for their districts increased from 4.4 to 4.7 (on a scale of 1 to 5). CONCLUSION: Implementing farm-to-school programming in Douglas County, Nebraska, is feasible, although food safety and distribution is a main concern among food service directors. Additional research on feasibility, infrastructure, and education is recommended.

Phase II trial of 9-nitrocamptothecin (RFS 2000) for patients with metastatic cutaneous or uveal melanoma.

The camptothecin derivative 9-nitrocamptothecin (9-NC) has demonstrated clinical activity in patients with ovarian and pancreatic carcinomas. Preclinical studies have shown promising activity of 9-NC for melanoma. We have thus conducted a phase II clinical trial of 9-NC for patients with metastatic cutaneous and uveal melanoma. Twenty-eight patients were enrolled in the trial, with diagnoses evenly divided between the two types of melanoma. 9-NC was administered orally at a starting dose of 1.5 mg/m(2)/day for 5 consecutive days of each week. No complete or partial responses were observed. Stabilization of disease was achieved in four individuals (15%) for durations of 3, 4, 6 and 8 months. Hematologic toxicity was moderate. Gastrointestinal side effects were common with 43% of the patients experiencing grade 3 or 4 diarrhea and 18% reporting grade 3 or 4 vomiting. In contrast to other 9-NC clinical trials, no patients developed chemical cystitis with gross hematuria. We conclude that, in keeping with the general chemoresistance of melanoma, 9-NC at the dose and schedule studied in this trial is significantly toxic and is not active for metastatic melanoma of cutaneous or uveal origin.