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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 1998 by National Cancer Institute (NCI). Recruitment status was Active, not recruiting

First Received on November 1, 1999. Last Updated on February 6, 2009 History of Changes

Sponsor:	Centro Oncologico de Excelencia
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002455

Purpose

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.

Condition	Intervention	Phase
Breast Cancer Colorectal Cancer Melanoma (Skin)	Biological: Corynebacterium granulosum P40 Procedure: adjuvant therapy	Phase III

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Immunotherapy of Colon Cancer With Autologous Perchloric Soluble Tumors Extracts

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Colorectal Cancer Melanoma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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

Study Start Date:

April 1971

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

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002455

Locations

Argentina
Centro Oncologico de Excelencia
Gonnet, Buenos Aires, Argentina, 1987 MB

Sponsors and Collaborators

Centro Oncologico de Excelencia

Investigators

Study Chair:

Hugo Omar De Carli, MD

Centro Oncologico de Excelencia

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00002455 History of Changes
Other Study ID Numbers:	CDR0000072435, ARG-CO/BR-1
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Breast Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Melanoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms

Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on February 09, 2012