Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma

A Phase II Study of Temozolomide (Temodar) and Peglated Interferon Alfa-2B (PEGIntron) in the Treatment of Advanced Melanoma

NCT00027742•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and interferon alfa in treating patients who have stage III or stage IV melanoma.

Detailed Description

OBJECTIVES: * Determine the response rate in patients with advanced melanoma treated with temozolomide and pegylated interferon alfa. * Determine the toxicity profile of this regimen in these patients. * Determine the duration of disease response and overall survival of patients treated with this regimen. OUTLINE: Patients are stratified according to CNS metastases (yes vs no). Patients receive oral temozolomide once daily on weeks 1-6 and pegylated interferon alfa subcutaneously once weekly on weeks 1-8. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 23-61 patients (12-35 without CNS metastases and 11-26 with CNS metastases) will be accrued for this study within 18 months.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•DISEASE CHARACTERISTICS:
•Histologically confirmed malignant melanoma
•* Unresectable stage III or stage IV disease
•* Ocular, mucosal, or cutaneous melanoma
•Measurable disease
•PATIENT CHARACTERISTICS:
•Age:
•18 and over
•Performance status:
•Karnofsky 70-100%
+47 more criteria

Locations (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

May 1, 2001

Primary Completion Date

June 1, 2005

Completion Date

June 1, 2005

Last Updated

June 5, 2013

Conditions

Intraocular MelanomaMelanoma (Skin)

Interventions

pegylated interferon alfa

BIOLOGICAL

temozolomide

DRUG

Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma

NCT07136181

Metastatic Uveal MelanomaUveal Melanoma, Metastatic+3 more

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RECRUITINGPHASE3

Adjuvant Melatonin for Uveal Melanoma

NCT05502900

Uveal MelanomaUveal Melanoma, Posterior, Medium/Large Size+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 5, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma

Inclusion Criteria

Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma

Adjuvant Melatonin for Uveal Melanoma

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