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

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)	Drug: Corynebacterium granulosum P40 Procedure: adjuvant therapy	Phase III

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer Colorectal Cancer Melanoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

Official Title:	Immunotherapy of Colon Cancer With Autologous Perchloric Soluble Tumors Extracts

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, Buenos Aires
	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

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000072435, ARG-CO/BR-1
First Received:	November 1, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00002455
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

Study placed in the following topic categories:

Digestive System Neoplasms

Skin Diseases

Gastrointestinal Diseases

Colonic Diseases

Breast Neoplasms

Intestinal Diseases

Rectal Diseases

Recurrence

Intestinal Neoplasms

Neuroendocrine Tumors

Melanoma

Neuroectodermal Tumors

Digestive System Diseases

Nevus, Pigmented

Neoplasms, Germ Cell and Embryonal

Neuroepithelioma

Gastrointestinal Neoplasms

Nevus

Colonic Neoplasms

Colorectal Neoplasms

Breast Diseases

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Neoplasms by Site

Neoplasms, Nerve Tissue

Nevi and Melanomas

ClinicalTrials.gov processed this record on August 28, 2008

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