Glendale, Arizona 85306

  • Melanoma (Skin)

Purpose:

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. 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. It is not yet known whether interferon alfa is more effective with or without combination chemotherapy and interleukin-2 for melanoma. PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without combination chemotherapy consisting of cisplatin, vinblastine, and dacarbazine, plus interleukin-2, in treating patients who have melanoma.


Study summary:

OBJECTIVES: - Compare the overall survival and disease-free survival of patients with high-risk melanoma treated with interferon alfa vs cisplatin, vinblastine, and dacarbazine plus interferon alfa and interleukin-2. - Compare the toxic effects of these treatment regimens in these patients. - Determine the relationship between minimal residual disease (MRD) status at 12 weeks and 52 weeks and overall survival of patients treated with these regimens. - Compare the effects of these treatment regimens on the MRD status of these patients. - Determine the relationship between clinical characteristics (number of involved lymph nodes, ulcerated primary, and extracapsular extension) and MRD in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to nodal status (N1 or N2 vs N3), degree of lymph node involvement (micrometastases only vs any macrometastases, including satellite/in-transit metastases), and ulceration of the primary tumor (yes vs no vs unknown primary). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive interferon alfa IV on days 1-5 of weeks 1-4 followed by interferon alfa subcutaneously (SC) on days 1, 3, and 5 of weeks 5-52 in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive cisplatin IV over 30 minutes followed by vinblastine IV on days 1-4. Patients also receive dacarbazine IV over 1 hour on day 1, interleukin-2 IV over 96 hours on days 1-4, and interferon alfa SC on days 1-5, 8, 10, and 12. In addition, patients receive filgrastim (G-CSF) SC on days 6-15. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 410 patients (205 per treatment arm) will be accrued for this study within 3 years.


Criteria:

DISEASE CHARACTERISTICS: - Histologically proven melanoma of cutaneous origin or from unknown primary at initial presentation of primary or first clinically detected nodal or satellite/in-transit recurrence - No distant metastases - No melanoma of ocular, mucosal, or other non-cutaneous origin - One of the following criteria must apply for patients with newly diagnosed melanoma OR a previously diagnosed primary with current subsequent, clinical, regional nodal disease and/or satellite/in-transit disease: - Ulcerated primary melanoma with 1 or more involved lymph nodes (micro/occult or macro/clinically overt) - Non-ulcerated or unknown primary melanoma with one macro/clinically overt lymph node metastasis, including a single matted nodal mass - No non-ulcerated or unknown primary tumor and a single micrometastatic lymph node - Non-ulcerated melanoma with two or more lymph node metastases (micro/occult or macro/clinically overt) and/or matted nodes - Any satellite/in transit metastasis with or without lymph node involvement - Patients with recurrent disease must have recurrent disease in the regional nodal basin of a prior complete lymphadenectomy - Multiple regional nodal basin involvement allowed if they are appropriate anatomic drainage basins for primary site - Patients must be disease free at time of enrollment based on the following surgical criteria: - Patients at initial presentation of melanoma must undergo adequate wide excision of primary lesion - Patients with previously diagnosed melanoma must have all disease resected with pathologically negative margins and no disease at primary site or second resection of primary - Full lymphadenectomy required of all patients including those with positive sentinel nodes or positive satellite/in-transit metastasis - No more than 56 days since prior lymphadenectomy OR surgery to remove recurrent disease after prior complete lymphadenectomy - Must be willing to participate in minimal residual disease studies if registered on the study on 3/1/2003 or later PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Zubrod 0-1 Life expectancy: - Not specified Hematopoietic: - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGOT or SGPT no greater than 2 times ULN - LDH and alkaline phosphatase no greater than 2 times ULN (above normal value requires a contrast-enhanced CT scan or MRI of liver) - No known recent hepatitis positivity by PCR Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 75 mL/min Cardiovascular: - No congestive heart failure - No coronary artery disease - No serious cardiac arrhythmia - No prior myocardial infarction - Normal cardiac stress test required if any of the following are present: - Over age 50 - Abnormal EKG - History of cardiac disease Pulmonary: - No symptomatic pulmonary disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No autoimmune disorders or conditions of immunosuppression - No other prior malignancy within the past 5 years except the following: - Adequately treated basal cell or squamous cell skin cancer - Carcinoma in situ of the cervix - Adequately treated stage I or II cancer in remission - HIV negative - No known AIDS or HIV-1 associated complex PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior immunotherapy, including interferon, interleukin, levamisole, or other biologic response modifiers - No other concurrent biologic therapy Chemotherapy: - No prior chemotherapy (including infusion or perfusion therapy) - No other concurrent chemotherapy Endocrine therapy: - No concurrent systemic corticosteroids or topical steroid creams - Concurrent steroid antihistamines allowed if no alternative - No concurrent hormonal therapy Radiotherapy: - No prior radiotherapy - Prior postlumpectomy radiotherapy for breast cancer allowed - No concurrent radiotherapy Surgery: - See Disease Characteristics - No concurrent surgery Other: - No concurrent anti-hypertensive medications (arm II only) - No concurrent immunosuppressive agents - No other concurrent anticancer therapy - Antihistamines allowed if no alternative medication suitable


NCT ID:

NCT00006237


Primary Contact:

Study Chair
Lawrence E. Flaherty, MD
Barbara Ann Karmanos Cancer Institute


Backup Contact:

N/A


Location Contact:

Glendale, Arizona 85306
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: July 30, 2021

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