Overview

This trial is active, not recruiting.

Condition melanoma (skin)
Treatment polyvalent melanoma vaccine
Phase phase 2
Sponsor CancerVax Corporation
Start date July 2005
Trial identifier NCT00128583, CDR0000439529, CV-MMAIT-5-001

Summary

RATIONALE: Vaccines made from tumor cells may help the body build an effective immune response to kill tumor cells.

PURPOSE: This phase II trial is studying vaccine therapy to see how well it works in treating patients with malignant melanoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Response
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed malignant melanoma - At least 1 in-transit skin lesion measuring 3-10 mm in the longest diameter PATIENT CHARACTERISTICS: Age - 18 to 80 Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified

Additional Information

Official title Response of In-Transit Melanoma to Systemic Treatment With the Specific Active Immunotherapeutic Agent, Canvaxin™
Description OBJECTIVES: - Determine the response in patients with in-transit cutaneous malignant melanoma treated with active immunotherapy comprising polyvalent melanoma vaccine (Canvaxin™). OUTLINE: This is an open-label, multicenter study. Patients receive polyvalent melanoma vaccine (Canvaxin™) subcutaneously to the armpit and groin areas every 2 weeks for approximately 10 weeks (5 doses) and then every 4 weeks for up to approximately 1 year of total treatment (total of 15 doses). Patients with no evidence of response at week 24 receive no further treatment. Patients whose disease continues to respond after completion of study treatment are eligible for a new study in which they will continue treatment with polyvalent melanoma vaccine (Canvaxin™). After completion of study treatment, patients are followed at 30 days. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).