Interferon Alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002882
• Other study ID #: ID95-196
• Secondary ID: P30CA016672MDA-I
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: December 12, 2011
• Start date: November 1995
• Est. completion date: April 2006

Study information

• Verified date: December 2011
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known whether interferon alfa plus combination chemotherapy and interleukin-2 is more effective than interferon alfa alone in treating patients with melanoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without combination chemotherapy plus interleukin-2 in treating patients with melanoma.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 2006
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Skin Cancer

Intervention

Biological:
• Aldesleukin (IL-2)
Infusion for a total of 96 hours on days 1-4
• Recombinant Interferon Alfa (IFN-A)
IFN-A Therapy Groups: 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 Group: IFN-A is given subcutaneously on days 1-5

Drug:
• Cisplatin
IV Days 1-4
• Dacarbazine
IVPB on day 1
• Vinblastine
IVPB on days 1-4

Procedure:
• Adjuvant Therapy
Patients receiving adjuvant radiotherapy will start adjuvant systemic therapy within 8 weeks from lymphadenectomy and a week after completion of and recovery from radiotherapy.

Locations

Country	Name	City	State
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kim KB, Legha SS, Gonzalez R, Anderson CM, Johnson MM, Liu P, Papadopoulos NE, Eton O, Plager C, Buzaid AC, Prieto VG, Hwu WJ, Frost AM, Alvarado G, Hwu P, Ross MI, Gershenwald JE, Lee JE, Mansfield PF, Benjamin RS, Bedikian AY. A randomized phase III tri — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of Interferon Alfa with/without Combination Chemotherapy + Interleukin-2 for Melanoma		1 year	No

External Links

•   UT MD Anderson Cancer Center Website