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

Breast Cancer Clinical Trial

Official title:

Immunotherapy of Colon Cancer With Autologous Perchloric Soluble Tumors Extracts

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00002455
• Other study ID #: ARG-CO/BR-1
• Secondary ID: CDR0000072435
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: August 6, 2013
• Start date: April 1971

Study information

• Verified date: November 1998
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Colorectal Cancer
• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• Corynebacterium granulosum P40

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
Argentina	Centro Oncologico de Excelencia	Gonnet	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Centro Oncologico de Excelencia

Country where clinical trial is conducted

Argentina, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence			No
Primary	Response to study parameters			No
Primary	Survival rate			No