TREATMENT OF METASTATIC MELANOMA WITH DTIC, CDDP AND IFN ALPHA WITH OR WITHOUT IL-2: A RANDOMIZED PHASE III TRIAL


Phase 2
18 Years
70 Years
Not Enrolling
Both
Melanoma (Skin)

Thank you

Trial Information

TREATMENT OF METASTATIC MELANOMA WITH DTIC, CDDP AND IFN ALPHA WITH OR WITHOUT IL-2: A RANDOMIZED PHASE III TRIAL


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Ulrich Keilholz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

Authority:

United States: Federal Government

Study ID:

EORTC-18951

NCT ID:

NCT00002669

Start Date:

June 1995

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

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