Overview

This trial is active, not recruiting.

Conditions breast cancer, colorectal cancer, melanoma (skin)
Treatments corynebacterium granulosum p40, adjuvant therapy
Phase phase 3
Sponsor Centro Oncologico de Excelencia
Start date April 1971
Trial identifier NCT00002455, ARG-CO/BR-1, CDR0000072435

Summary

RATIONALE: Immunotherapy uses different ways to stimulate the immune system and stop cancer cells from growing. Immunotherapy biological extracts may be useful as adjuvant therapy in treating patients who have had surgery for breast cancer, colon cancer, or melanoma.

PURPOSE: Phase III trial to study the effectiveness of Corynebacterium granulosum extract as maintenance immunotherapy following surgery in treating patients with breast cancer, colon cancer, or melanoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Primary Outcomes

Measure
Recurrence
time frame:
Response to study parameters
time frame:
Survival rate
time frame:

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

DISEASE CHARACTERISTICS: - Diagnosis of colon cancer, breast cancer, or melanoma with minimal residual disease (at least 90% of tumor mass resected) after surgical resection - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 20 to 80 Sex: - Not specified Menopausal status: - Not specified 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 - See Disease Characteristics

Additional Information

Official title Immunotherapy of Colon Cancer With Autologous Perchloric Soluble Tumors Extracts
Description OBJECTIVES: - Determine the survival of patients with colon cancer, breast cancer, or melanoma with minimal residual disease after surgical resection treated with maintenance immunotherapy using Corynebacterium granulosum P40. - Determine leucocyte adherence inhibition, an indication of metastases, over time in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified by center and are matched with case-controls by disease type and stage. Beginning 2 weeks after surgical resection, patients receive Corynebacterium granulosum P40 subcutaneously weekly for 6 weeks, followed by rest for 3 months. Treatment continues for life. Patients are followed for survival. PROJECTED ACCRUAL: Not specified
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).