Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	18 and over	NCI, Other	CDR0000065617 E-E3695, CLB-509802, SWOG-E3695, NCT00003027

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Interferon alfa may interfere with the growth of tumor cells. It is not yet known whether combination chemotherapy plus interleukin-2 and interferon alfa is more effective than combination chemotherapy alone for metastatic melanoma.

PURPOSE: Randomized phase III trial to compare combination chemotherapy with or without interleukin-2 and interferon alfa in treating patients who have metastatic melanoma that cannot be treated by surgery.

Further Study Information

OBJECTIVES:

• Compare response rate, duration of response, and survival rate in patients with metastatic malignant melanoma treated with cisplatin, vinblastine, and dacarbazine with or without interleukin-2 and interferon alfa-2b.

• Determine the toxic effects of these regimens in this patient population.

OUTLINE: This is a randomized study. Patients are stratified according to performance status (0 vs 1), prior interferon (yes vs no), and number of involved sites. Patients are randomized to one of two treatment arms.

• Arm I: Patients receive cisplatin IV over 30 minutes daily immediately followed by vinblastine IV on days 1-4. Patients also receive dacarbazine IV over 60 minutes on day 1 following vinblastine.

• Arm II: Patients receive treatment as in arm I. Patients also receive interleukin 2 (IL-2) IV continuously on days 1-4 and interferon alfa-2b subcutaneously (SC) daily before IL-2 on days 1-4 and after IL-2 on day 5, followed by filgrastim (G-CSF) (SC) daily on days 7-16.

Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 6 weeks, every 3 months for 18 months, every 6 months for 18 months, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 482 patients will be accrued for this study within 3.5 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed surgically incurable metastatic malignant melanoma

• Measurable disease

• No active brain metastases or edema

• No leptomeningeal disease

• No ocular melanoma

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 9 g/dL

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• SGOT less than 3 times the upper limit of normal unless due to liver metastases

Renal:

• Creatinine less than 1.5 mg/dL OR

• Creatinine clearance at least 75 mL/min

Cardiovascular:

• No congestive heart failure

• No symptoms of coronary artery disease

• No serious cardiac arrhythmias

• No prior myocardial infarction on EKG

• Normal cardiac stress test required for the following:

• Over 50 years of age

• Abnormal EKG

• Prior history of cardiac disease

Pulmonary:

• No symptomatic pulmonary disease

• FEV1 greater than 2.0 L OR at least 75% predicted if over 50 years of age or with history of pulmonary symptoms

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No significant infection

• HIV negative

• No other prior malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• No organ allografts

• No significant disease other than malignancy

• No seizure disorder

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior interleukin-2 therapy for metastatic disease

• At least 4 weeks since prior vaccine therapy

• At least 4 weeks since prior adjuvant immunotherapy

Chemotherapy:

• No prior chemotherapy for disease

Endocrine therapy:

• No concurrent corticosteroids

Radiotherapy:

• No prior radiation therapy to measurable disease site unless disease is clearly progressive

• At least 4 weeks since prior radiation therapy for local control or palliation and recovered

Surgery:

• Recovered from prior surgery

Other:

• No prior systemic therapy for metastatic disease

• At least 3 months since definitive therapy for brain metastases

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

Michael Benjamin Atkins

Study Chair

Lawrence E. Flaherty

Study Chair

David M. Gustin, MD

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00003027
Information obtained from ClinicalTrials.gov on October 06, 2009

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