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

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

February 6, 2009

Start Date ^ICMJE

April 1971

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Recurrence [ Designated as safety issue: No ]
Response to study parameters [ Designated as safety issue: No ]
Survival rate [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Recurrence
Response to study parameters
Survival rate

Change History

Complete list of historical versions of study NCT00002455 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Immunotherapy of Colon Cancer With Autologous Perchloric Soluble Tumors Extracts

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Breast Cancer
Colorectal Cancer
Melanoma (Skin)

Intervention ^ICMJE

Biological: Corynebacterium granulosum P40
Procedure: adjuvant therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Argentina

Administrative Information

NCT ID ^ICMJE

NCT00002455

Responsible Party

Study ID Numbers ^ICMJE

CDR0000072435, ARG-CO/BR-1

Study Sponsor ^ICMJE

Centro Oncologico de Excelencia

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Hugo Omar De Carli, MD

Centro Oncologico de Excelencia

Information Provided By

National Cancer Institute (NCI)

Verification Date

November 1998

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP