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Interferon Alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma
This study has been completed.

First Received on November 1, 1999.   Last Updated on December 12, 2011   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by (Responsible Party): M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00002882
  Purpose

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.


Condition Intervention Phase
Melanoma
Skin Cancer
 Biological: Aldesleukin (IL-2)
Biological: Recombinant Interferon Alfa (IFN-A)
Drug: Cisplatin
Drug: Dacarbazine
Drug: Vinblastine
Procedure: Adjuvant Therapy
 Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma Skin Cancer
Drug Information available for: Cisplatin Interferon alfa-2a Interferon alfa-2b Interleukin-2 Aldesleukin Interferon alfa-n1 Vinblastine sulfate Vinblastine Dacarbazine Interferons
U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Effectiveness of Interferon Alfa with/without Combination Chemotherapy + Interleukin-2 for Melanoma [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: November 1995
Study Completion Date: April 2006
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IFN-A Therapy Schedule A
Schedule A: IV Interferon alfa-2b (IFN-A) induction 5 times a week for 4 weeks followed by subcutaneous IFN-A maintenance 3 times a week for 48 weeks.
 Biological: 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

Other Names:
  • interferon alfa-2b
  • IFN-A
Experimental: IFN-A Therapy Schedule B
Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks.
 Biological: 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

Other Names:
  • interferon alfa-2b
  • IFN-A
Experimental: Adjuvant Biochemotherapy
Cisplatin IV Days 1-4; Vinblastine IVPB Days 1-4; Dacarbazine (DTIC) IVPB on Day 1; IFN-A is given subcutaneously on days 1-5; IL-2 continuous infusion for 96 hours on Days 1-4. Each course repeated every 21 days for 4 courses.
 Biological: Aldesleukin (IL-2)
Infusion for a total of 96 hours on days 1-4
Other Names:
  • IL-2
  • Interleukin-2
  • Proleukin
Biological: 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

Other Names:
  • interferon alfa-2b
  • IFN-A
Drug: Cisplatin
IV Days 1-4
Other Names:
  • CDDP
  • Platinol
  • Platinol-AQ
Drug: Dacarbazine
IVPB on day 1
Other Names:
  • dacarbazine
  • DTIC
Drug: Vinblastine
IVPB on days 1-4
Other Name: Velban
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   10 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002882

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Agop Y. Bedikian, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
UT MD Anderson Cancer Center Website  This link exits the ClinicalTrials.gov site

Publications:
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 trial of biochemotherapy versus interferon-alpha-2b for adjuvant therapy in patients at high risk for melanoma recurrence. Melanoma Res. 2009 Feb;19(1):42-9.

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00002882     History of Changes
Other Study ID Numbers: ID95-196, P30CA016672, MDA-ID-95196, MDA-DM-95196, NCI-G96-1089, CDR0000065188
Study First Received: November 1, 1999
Last Updated: December 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
stage III melanoma

Additional relevant MeSH terms:
Skin Neoplasms
Melanoma
Neoplasms by Site
Neoplasms
Skin Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Adjuvants, Immunologic
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
 Interferons
Aldesleukin
Cisplatin
Dacarbazine
Interleukin-2
Vinblastine
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances

ClinicalTrials.gov processed this record on February 09, 2012



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