S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Intervention: interleukin-2; filgrastim; interferon alfa; cisplatin; dacarbazine; vinblastine
Intervention description: Given IV; Given subcutaneously; Given IV and subcutaneously; Given IV; Given IV; Given IV
Intervention MeSH terms: Interferons; Interferon-alpha; Aldesleukin; Interleukin-2; Dacarbazine; Vinblastine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 432.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage III melanoma; recurrent melanoma

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.
    

Eligibility 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