NCT00003027

Combination Chemotherapy With or Without Interleukin-2 and Interferon Alfa in Treating Patients With Metastatic Melanoma

Official Title:

A Randomized Phase III Trial of Concurrent Biochemotherapy With Cisplatin, Vinblastine, Dacarbazine, IL-2 and Interferon A-2B Versus Cisplatin, Vinblastine, Dacarbazine Alone in Patients With Metastatic Malignant Melanoma

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.

Eligibility

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

Disease(s) and\or Condition(s)

Melanoma (Skin)

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: BIOLOGICAL
    • Name: aldesleukin
    • Description:
    • Arm Group Labels:
    • Type: BIOLOGICAL
    • Name: filgrastim
    • Description:
    • Arm Group Labels:
    • Type: BIOLOGICAL
    • Name: recombinant interferon alfa
    • Description:
    • Arm Group Labels:
    • Type: DRUG
    • Name: cisplatin
    • Description:
    • Arm Group Labels:
    • Type: DRUG
    • Name: dacarbazine
    • Description:
    • Arm Group Labels:
    • Type: DRUG
    • Name: vinblastine
    • Description:
    • Arm Group Labels:
Sponsor
  • Eastern Cooperative Oncology Group