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

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ClinicalTrials.gov 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)

November 1, 1999
January 27, 2003
August 7, 2013
April 1971
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  • Recurrence
  • Response to study parameters
  • Survival rate
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Complete list of historical versions of study NCT00002455 on ClinicalTrials.gov Archive Site
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Immunotherapy After Surgery in Treating Patients With Breast Cancer, Colon Cancer, or Melanoma
Immunotherapy of Colon Cancer With Autologous Perchloric Soluble Tumors Extracts

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.


  • 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.


Phase 3
Primary Purpose: Treatment
  • Breast Cancer
  • Colorectal Cancer
  • Melanoma (Skin)
  • Biological: Corynebacterium granulosum P40
  • Procedure: adjuvant therapy
Not Provided
De Carli HO: Immunostimulation and follow-up in long term subclinical cancer. Buenos Aires. Argentina: Centro Oncologico de Excelencia.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
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  • 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
Sexes Eligible for Study: All
20 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
CDR0000072435 ( Registry Identifier: PDQ (Physician Data Query) )
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Centro Oncologico de Excelencia
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Study Chair: Hugo Omar De Carli, MD Centro Oncologico de Excelencia
National Cancer Institute (NCI)
November 1998

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