- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002882
Interferon Alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma
Adjuvant Therapy for Melanoma Patients With Regional Lymph Node Metastases With Interferon Alfa-2B vs. Biochemotherapy Using Cisplatin + Vinblastine + DTIC + Interferon Plus IL-2
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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:
|
Experimental: IFN-A Therapy Schedule B
Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks.
|
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:
|
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.
|
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:
Infusion for a total of 96 hours on days 1-4
Other Names:
IV Days 1-4
Other Names:
IVPB on day 1
Other Names:
IVPB on days 1-4
Other Names:
Patients receiving adjuvant radiotherapy will start adjuvant systemic therapy within 8 weeks from lymphadenectomy and a week after completion of and recovery from radiotherapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effectiveness of Interferon Alfa with/without Combination Chemotherapy + Interleukin-2 for Melanoma
Time Frame: 1 year
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1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Agop Y. Bedikian, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antineoplastic Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Antineoplastic Agents, Phytogenic
- Interferons
- Interferon-alpha
- Aldesleukin
- Cisplatin
- Interferon alpha-2
- Dacarbazine
- Interleukin-2
- Vinblastine
Other Study ID Numbers
- ID95-196
- P30CA016672 (U.S. NIH Grant/Contract)
- MDA-ID-95196 (Other Identifier: UT MD Anderson Cancer Center)
- MDA-DM-95196 (Other Identifier: UT MD Anderson Cancer Center)
- NCI-G96-1089
- CDR0000065188 (Registry Identifier: NCI PDQ)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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