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Phase III Study of Maintenance Immunotherapy With Corynebacterium granulosum P40 in Patients With Colon Cancer, Breast Cancer, or Melanoma With Minimal Residual Disease After Surgical Resection

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Related Publications
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III

Treatment

Closed

20 to 80

Other

ARG-CO/BR-1
NCT00002455

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.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

See Disease Characteristics

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

Expected Enrollment

Not specified

Outcomes

Primary Outcome(s)

Recurrence
Response to study parameters
Survival rate

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.

Related Publications

De Carli HO: Immunostimulation and follow-up in long term subclinical cancer. Buenos Aires. Argentina: Centro Oncologico de Excelencia.

Trial Contact Information

Trial Lead Organizations

Centro Oncologico de Excelencia

Hugo Omar De Carli, MD, Protocol chair
Ph: 54-21-84-3119

Registry Information

Official Title		Immunotherapy of Colon Cancer with Autologous Perchloric Soluble Tumors Extracts

Trial Start Date		1971-04-01

Registered in ClinicalTrials.gov		NCT00002455

Date Submitted to PDQ		1997-08-18

Information Last Verified		1998-11-24

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.