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

NCT00002882 | Completed Phase 3

• 6 other identifiers: ID95-196P30CA016672MDA-ID-95196MDA-DM-95196NCI-G96-1089CDR0000065188
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melanoma; Skin Cancer

Keywords

stage III melanoma

Outcome Measures

Primary Outcomes (1)

• Effectiveness of Interferon Alfa with/without Combination Chemotherapy + Interleukin-2 for Melanoma

  1 year

Study Arms (3)

IFN-A Therapy Schedule A

EXPERIMENTAL

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 Schedule B

EXPERIMENTAL

Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks.

Biological: Recombinant Interferon Alfa (IFN-A)

Adjuvant Biochemotherapy

EXPERIMENTAL

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); Biological: Recombinant Interferon Alfa (IFN-A); Drug: Cisplatin; Drug: Dacarbazine; Drug: Vinblastine; Procedure: Adjuvant Therapy

Interventions

Aldesleukin (IL-2) BIOLOGICAL

Infusion for a total of 96 hours on days 1-4

Also known as: IL-2, Interleukin-2, Proleukin

Adjuvant Biochemotherapy

Recombinant Interferon Alfa (IFN-A) BIOLOGICAL

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

Also known as: interferon alfa-2b, IFN-A

Adjuvant Biochemotherapy; IFN-A Therapy Schedule A; IFN-A Therapy Schedule B

Cisplatin DRUG

IV Days 1-4

Also known as: CDDP, Platinol, Platinol-AQ

Adjuvant Biochemotherapy

Dacarbazine DRUG

IVPB on day 1

Also known as: DTIC

Adjuvant Biochemotherapy

Vinblastine DRUG

IVPB on days 1-4

Also known as: Velban

Adjuvant Biochemotherapy

Adjuvant Therapy PROCEDURE

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

Adjuvant Biochemotherapy

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Related 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 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. doi: 10.1097/CMR.0b013e328314b84a.

  PMID: 19430405 RESULT

Related Links

• UT MD Anderson Cancer Center Website

MeSH Terms

Conditions

Melanoma; Skin Neoplasms

Interventions

aldesleukin; Interleukin-2; Interferon-alpha; Interferon alpha-2; Cisplatin; Dacarbazine; Vinblastine; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Interferon Type I; Interferons; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Agop Y. Bedikian, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: November 1, 1995
• Primary Completion: August 1, 2003
• Study Completion: April 1, 2006
• Last Updated: December 13, 2011

Record last verified: 2011-12

Locations

US (1)