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Adjuvant Therapy for Melanoma Patients With Regional Lymph Node Metastases With Interferon Alfa-2B vs. Biochemotherapy Using Cisplatin + Vinblastine + DTIC + Interferon Plus IL-2

Phase 3
10 Years
70 Years
Not Enrolling
Melanoma, Skin Cancer

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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


- 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

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

PROJECTED ACCRUAL: A total of 200 patients (100 patients in each arm) will be entered.

Inclusion Criteria


- 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



- 10 to 66

- 66 to 70 if in excellent physical condition

Performance status:

- 0-2

Life expectancy:

- At least 12 months


- Hemoglobin greater than 10 g/dL

- WBC greater than 3,000/mm^3

- Platelet count greater than 100,000/mm^3


- Bilirubin no greater than 1.2 mg/dL


- Creatinine no greater than 1.5 mg/dL


- 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


Biologic therapy:

- No prior immunotherapy with interferon or IL-2

- No concurrent immunomodulators


- No prior chemotherapy

Endocrine therapy:

- No concurrent steroids


- Prior adjuvant local radiotherapy allowed for head and neck


- No greater than 8 weeks after definitive surgery for lymph node metastases


- No concurrent nonsteroid anti-inflammatory drugs, or other prostaglandin synthetase

Type of Study:


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:


Principal Investigator

Agop Y. Bedikian, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

November 1995

Completion Date:

April 2006

Related Keywords:

  • Melanoma
  • Skin Cancer
  • stage III melanoma
  • Skin Neoplasms
  • Melanoma



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009