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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002455
Recruitment Status : Unknown
Verified November 1998 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : August 7, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Colorectal Cancer Melanoma (Skin) Biological: Corynebacterium granulosum P40 Procedure: adjuvant therapy Phase 3

Detailed Description:


  • 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.


Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Immunotherapy of Colon Cancer With Autologous Perchloric Soluble Tumors Extracts
Study Start Date : April 1971

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Primary Outcome Measures :
  1. Recurrence
  2. Response to study parameters
  3. Survival rate

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 20 to 80


  • Not specified

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002455

Centro Oncologico de Excelencia
Gonnet, Buenos Aires, Argentina, 1987 MB
Sponsors and Collaborators
Centro Oncologico de Excelencia
Study Chair: Hugo Omar De Carli, MD Centro Oncologico de Excelencia

De Carli HO: Immunostimulation and follow-up in long term subclinical cancer. Buenos Aires. Argentina: Centro Oncologico de Excelencia. Identifier: NCT00002455     History of Changes
Other Study ID Numbers: ARG-CO/BR-1
CDR0000072435 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: November 1998

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