Adjuvant Therapy for Melanoma Patients With Regional Lymph Node Metastases With Interferon Alfa-2B vs. Biochemotherapy Using Cisplatin + Vinblastine + DTIC + Interferon Plus IL-2
10 Years
70 Years
Both
Melanoma, Skin Cancer
Trial Information
Adjuvant Therapy for Melanoma Patients With Regional Lymph Node Metastases With Interferon Alfa-2B vs. Biochemotherapy Using Cisplatin + Vinblastine + DTIC + Interferon Plus IL-2
OBJECTIVES:
- Compare the efficacy of postoperative adjuvant therapy with interferon alfa-2b (IFN-A)
administered subcutaneously with or without IV induction vs concurrent biochemotherapy
including cisplatin, vinblastine, DTIC, IFN-A and IL-2 and in melanoma patients with
regional lymph node metastases that have been surgically resected.
- Determine the relative toxic effects associated with adjuvant therapy with IFN-A and
concurrent biochemotherapy including cisplatin, vinblastine, DTIC, IFN-A, and IL-2 and
their effect on the quality of life.
- Determine the prognostic value of detection of melanoma cells in the peripheral blood
using RT/PCR for tyrosinase mRNA.
OUTLINE: This is a randomized study. All patients are stratified according to prognostic
factors.
Patients are randomly allocated to 1 of 2 treatment options. Treatment 1 uses interferon
alfa-2b (IFN-A) therapy, and treatment 2 includes adjuvant biochemotherapy.
Patients who are randomized to IFN-A will be further stratified and randomized to one of two
interferon schedules.
- Schedule A: IV IFN-A induction 5 times a week for 4 weeks followed by subcutaneous
IFN-A maintenance 3 times a week for 48 weeks.
- Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks. Adjuvant biochemotherapy
begins immediately after registration on the study. Cisplatin is given IV on days 1-4;
vinblastine is given IVPB on days 1-4; dacarbazine (DTIC) is given IVPB on day 1; IFN-A
is given subcutaneously on days 1-5; IL-2 is given by continuous infusion for a total
of 96 hours on days 1-4. Each course of therapy is repeated every 21 days for 4
courses. Patients receiving adjuvant radiotherapy will start adjuvant systemic therapy
within 8 weeks from lymphadenectomy and a week after completion of and recovery from
radiotherapy.
PROJECTED ACCRUAL: A total of 200 patients (100 patients in each arm) will be entered.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically diagnosed malignant melanoma with regional lymph node metastases
- Undergone complete lymph node dissection and free of any residual tumor
- No greater than 90 days from diagnosis of regional lymph nodes metastases
- No distant or resected in-transit metastases
PATIENT CHARACTERISTICS:
Age:
- 10 to 66
- 66 to 70 if in excellent physical condition
Performance status:
- 0-2
Life expectancy:
- At least 12 months
Hematopoietic:
- Hemoglobin greater than 10 g/dL
- WBC greater than 3,000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.2 mg/dL
Renal:
- Creatinine no greater than 1.5 mg/dL
Other:
- No serious intercurrent illness that would compromise tolerance of therapy and long
term survival
- Must be able to participate in follow up for minimum of 5 years
- No second malignancy except:
- In situ cervical cancer
- Basal or squamous skin cancer
- Must be able to physically and emotionally tolerate biochemotherapy
- No history of pulmonary or cardiac dysfunction, e.g., cardiac rhythm disturbance,
congestive heart failure, coronary bypass, or impaired cardiac ejection fraction
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy with interferon or IL-2
- No concurrent immunomodulators
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- No concurrent steroids
Radiotherapy:
- Prior adjuvant local radiotherapy allowed for head and neck
Surgery:
- No greater than 8 weeks after definitive surgery for lymph node metastases
Other:
- No concurrent nonsteroid anti-inflammatory drugs, or other prostaglandin synthetase
inhibitors
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Effectiveness of Interferon Alfa with/without Combination Chemotherapy + Interleukin-2 for Melanoma
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Agop Y. Bedikian, MD
Investigator Role:
Study Chair
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
ID95-196
NCT ID:
NCT00002882
Start Date:
November 1995
Completion Date:
April 2006
Related Keywords:
- Melanoma
- Skin Cancer
- stage III melanoma
- Skin Neoplasms
- Melanoma
Name | Location |
|---|---|
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
