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Immunotherapy After Surgery in Treating Patients With Breast Cancer, Colon Cancer, or Melanoma

Immunotherapy of Colon Cancer With Autologous Perchloric Soluble Tumors Extracts

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002455
Enrollment
Unknown
Registered
2003-01-27
Start date
1971-04-30
Completion date
Unknown
Last updated
2013-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Colorectal Cancer, Melanoma (Skin)

Keywords

stage I colon cancer, stage II colon cancer, stage III colon cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, recurrent breast cancer, recurrent colon cancer, stage I melanoma, stage II melanoma, stage III melanoma, recurrent melanoma

Brief 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.

Detailed 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

Interventions

BIOLOGICALCorynebacterium granulosum P40
PROCEDUREadjuvant therapy

Sponsors

Centro Oncologico de Excelencia
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Recurrence
Response to study parameters
Survival rate

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026