Trial | NCT00002669  Report issue

Title

Combination Chemotherapy, Interferon Alfa, and Interleukin-2 in Treating Patients With Metastatic Melanoma
TREATMENT OF METASTATIC MELANOMA WITH DTIC, CDDP AND IFN ALPHA WITH OR WITHOUT IL-2: A RANDOMIZED PHASE III TRIAL

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    90
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 the cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known which treatment regimen is more effective in treating melanoma.

PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of combination chemotherapy plus interferon alfa and interleukin-2 in treating patients who have metastatic melanoma.
OBJECTIVES:

Assess the rate of disease stabilization in patients with metastatic melanoma when treated with interferon alfa, dacarbazine, cisplatin, and interleukin-2.
Assess toxicity, overall response rate, and response duration in these patients when treated with this regimen.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center. Patients are randomized to one of two treatment arms.

Arm I: Patients receive dacarbazine IV over 1 hour and cisplatin IV over 3 hours on days 1-3. Patients also receive interferon alfa subcutaneously (SQ) on days 1-5 and interleukin-2 by continuous IV infusion on days 4-9. Treatment continues every 28 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive dacarbazine IV on day 1 and 22 every 28 days for 2 courses. Patients then receive treatment as in arm I for a maximum of 4 courses.

Patients are followed every 2 months for 6 months, then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 42-90 patients will be accrued for this study.
Study Started
Jun 30
1995
Primary Completion
Aug 31
2002
Last Update
Jul 02
2012
Estimate

Biological aldesleukin

Biological recombinant interferon alfa

Drug cisplatin

Drug dacarbazine

Criteria 

DISEASE CHARACTERISTICS:

Histologically confirmed melanoma that is metastatic and unresectable

Measurable, progressive disease (by physical exam and/or noninvasive imaging)

No prior irradiation of indicator lesions
No CNS metastases (confirmed by CT or MRI)

PATIENT CHARACTERISTICS:

Age:

18 to 70

Performance status:

Karnofsky 60-100%

Life expectancy:

Greater than 3 months

Hematopoietic:

WBC at least 2,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

No serious hepatic disease

Renal:

Creatinine no greater than 1.65 mg/dL
No serious renal disease

Cardiovascular:

No serious cardiac disease

Pulmonary:

No serious pulmonary disease

Other:

No organ allograft
No autoimmune disease
No uncontrolled infection
No active peptic ulcer
No hyper or hypothyroidism
No requirement for corticosteroids
No second malignancy except basal cell skin carcinoma or carcinoma in situ of the cervix
Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No prior immunotherapy with interleukin-2
No prior interferon alfa in combination with cisplatin or dacarbazine

Chemotherapy:

No prior chemotherapy with cisplatin in combination with dacarbazine
More than 3 months since prior chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

Prior radiotherapy allowed

Surgery:

Not specified
No Results Posted