Phase II studies of antiangiogenic four drug regimens for the treatment of advanced renal cell carcinoma: FUNIL-retinoid and the FUNIL-thalidomide protocols.

BACKGROUND AND PURPOSE: The objective of these studies was to determine the activity of two alternative 4- drug combinations using cis-retinoic acid or thalidomide administered with a previously developed combination of 5 fluorouracil, interferon-alpha, and interleukin 2 (FUNIL), for patients with metastatic renal cell carcinoma (RRC). METHODS: Patients enrolled in these studies had progressive measurable metastatic renal cell cancer and signed an informed consent. Treatments included continuous infusions of 5-fluorouracil, interferon-alpha, 6 MIU/m2 given subcutaneous on days 1, 3, and 5 every week, interleukin-2 6 MIU/m2/day given by continuous infusion days 2 to 5 every week, and either cis-retinoic acid at a dose of 1 mg/kg/day orally in two divided doses or thalidomide given at an initial dose of 200 mg per day. Each cycle consisted of 6 or 4 weeks of the combinations, respectively, followed by a 2-week rest. Patients were evaluated for response prior to each successive cycle. A 2-step mini-max statistical design was used. RESULTS: In the cis-retinoid study, 20 patients were enrolled. One patient was ineligible. There were 1 complete and 2 partial responses (one confirmed and one unconfirmed) (15.8%), 1 stable disease, and 15 disease progression. In the thalidomide combination study, 20 patients were enrolled, but only 19 are assessable. One patient progressed early and was never treated. There were 2 partial responses (10.5%), 4 stable disease, and 13 progressive disease. CONCLUSION: Neither the FUNIL-cis-retinoid nor the FUNIL-thalidomide regimens met their primary objective first step endpoint of 3 confirmed responses. Both regimens had significant adverse effects and neither is considered promising for further study.

Does HIV VCT reduce risk behaviors? An observational study in Guatemala City.

OBJECTIVE: We examined the impact of HIV voluntary counseling and testing on self-reported behavioral risks three months after HIV testing. DESIGN: Cohort study comparing self-reported risk behaviors prior to and three months after HIV testing. SETTING: Clinica Familiar Luis Angel Garcia, an HIV specialty clinic located in a Guatemalan National Hospital. SUBJECTS, PARTICIPANTS: 144 people undergoing HIV testing were enrolled. 44 were HIV positive. 41 HIV positive and 49 HIV negative subjects returned for follow-up interviews. INTERVENTION: All subjects were tested and received voluntary counseling regarding HIV infection, transmission, prevention, and interpretation of HIV test results. MAIN OUTCOME MEASURE: The primary study outcome measure was change in self-reported risk behaviors three months after voluntary counseling and testing. RESULTS: Men were more likely than women to report a history of sexually transmitted diseases, more than 2 sexual partners, using alcohol with sex, and receiving money for sex; they were less likely to have a regular partner. 26% of men reported non-heterosexual orientation; no woman did. Alcohol was the primary drug of abuse in both men and women. At three month follow-up HIV positive subjects showed decreases in the average number of sexual partners, use of alcohol with sex, and episodes of unprotected sex. CONCLUSIONS: Voluntary counseling and testing resulted in changes in some self-reported risk behaviors, but only among HIV positive subjects. On nearly all measures men report riskier behavior than women. Alcohol is the most commonly used drug in this population and is often used with sex.