Intensive therapy with cisplatin, interleukin-2 and interferon-alpha-2a in patients with metastatic melanoma. A phase II Study.
Online J Curr Clin Trials
; Doc No 9: [3841 words; 32 paragraphs], 1992 Jul 01.
Article
in En
| MEDLINE
| ID: mdl-1343617
ABSTRACT
OBJECTIVE:
Based upon their individual clinical activity and combined effects in animal models or in vitro, we wished to evaluate a regimen of cisplatin, interferon-alpha, and IL-2 in patients with metastatic melanoma.DESIGN:
Phase II pilot study.SETTING:
Referral-based US Government clinical research unit. PATIENTS Nine patients with metastatic malignant melanoma. INTERVENTION Cisplatin 75-100 mg/m2 was administered intravenously over 30 minutes on days 1 and 8. Interferon-alpha 2a 5 Mu/m2 body surface area (BSA) was given subcutaneously for 4 days beginning 1 day before each dose of cisplatin. Beginning on day 15 and day 22, IL-2 was administered by intravenous continuous infusion at 3 Mu/m2 BSA/d for 96 hours and by daily intravenous bolus concurrent with daily subcutaneous doses of interferon-alpha 2a. MAIN OUTCOMEMEASURES:
Antitumor response and toxicities.RESULTS:
The study was stopped due to renal and hematopoietic toxicity and severe, delayed nausea and vomiting associated with the cisplatin-interferon treatment. Three of 9 patients achieved a partial response (duration 2.5, 4, 14+ months), and an additional patient had a 50% reduction in measurable tumor volume before undergoing resection of residual disease. Overall response rate was 45%.CONCLUSION:
This regimen was associated with excessive toxicity, and the lack of complete responses in a patient cohort with favorable characteristics for response (good performance status, predominance of skin and lymph node metastatic sites) suggests that it had no advantage over less toxic treatment regimens. REGISTRATION National Cancer Institute/Cancer Therapy Evaluation Program T89-0137.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Interleukin-2
/
Cisplatin
/
Interferon-alpha
/
Melanoma
Type of study:
Prognostic_studies
Limits:
Adult
/
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Online J Curr Clin Trials
Journal subject:
MEDICINA
/
TERAPEUTICA
Year:
1992
Document type:
Article