S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborators: Cancer and Leukemia Group B; Children's Oncology Group; Eastern Cooperative Oncology Group; National Cancer Institute (NCI)
• Treatments: Aldesleukin; Cisplatin; Dacarbazine; Interferon-alpha; Interferons; Interleukin-2; Lenograstim; Vinblastine

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