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

Primary Purpose

Breast Cancer, Colorectal Cancer, Melanoma (Skin)

Status

Unknown status

Phase

Phase 3

Locations

Argentina

Study Type

Interventional

Intervention

Corynebacterium granulosum P40

adjuvant therapy

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring 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

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centro Oncologico de Excelencia

Outcomes

Primary Outcome Measures

Recurrence

Response to study parameters

Survival rate

Secondary Outcome Measures

Full Information

NCT ID

NCT00002455

First Posted

November 1, 1999

Last Updated

August 6, 2013

Sponsor

Centro Oncologico de Excelencia

1. Study Identification

Unique Protocol Identification Number

NCT00002455

Brief Title

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

Official Title

Immunotherapy of Colon Cancer With Autologous Perchloric Soluble Tumors Extracts

Study Type

Interventional

2. Study Status

Record Verification Date

November 1998

Overall Recruitment Status

Unknown status

Study Start Date

April 1971 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Centro Oncologico de Excelencia

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

Corynebacterium granulosum P40

Intervention Type

Procedure

Intervention Name(s)

adjuvant therapy

Primary Outcome Measure Information:

Title

Recurrence

Title

Response to study parameters

Title

Survival rate

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hugo Omar De Carli, MD

Organizational Affiliation

Centro Oncologico de Excelencia

Official's Role

Study Chair

Facility Information:

Facility Name

Centro Oncologico de Excelencia

City

Gonnet

State/Province

Buenos Aires

ZIP/Postal Code

1987 MB

Country

Argentina

12. IPD Sharing Statement

Citations:

Citation

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

Results Reference

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

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