NCT00006237
S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma
PHASE3
COMPLETED
NCT00006237
INTERVENTIONAL
Phase III Trial of High Dose Interferon Alfa 2-b Versus Cisplatin, Vinblastine, DTIC Plus IL-2 and Interferon in Patients With High Risk Melanoma
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.
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
Melanoma (Skin)
- TREATMENT
-
- Type: BIOLOGICAL
- Name: interleukin-2
- Description: Given IV
- Arm Group Labels: Arm II
-
- Type: BIOLOGICAL
- Name: filgrastim
- Description: Given subcutaneously
- Arm Group Labels: Arm II
-
- Type: BIOLOGICAL
- Name: interferon alfa
- Description: Given IV and subcutaneously
- Arm Group Labels: Arm I, Arm II
-
- Type: DRUG
- Name: cisplatin
- Description: Given IV
- Arm Group Labels: Arm II
-
- Type: DRUG
- Name: dacarbazine
- Description: Given IV
- Arm Group Labels: Arm II
-
- Type: DRUG
- Name: vinblastine
- Description: Given IV
- Arm Group Labels: Arm II
- SWOG Cancer Research Network