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
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002455
First received: November 1, 1999
Last updated: August 6, 2013
Last verified: November 1998

November 1, 1999
August 6, 2013
April 1971
Not Provided
  • Recurrence [ Designated as safety issue: No ]
  • Response to study parameters [ Designated as safety issue: No ]
  • Survival rate [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00002455 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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

Interventional
Phase 3
Primary Purpose: Treatment
  • Breast Cancer
  • Colorectal Cancer
  • Melanoma (Skin)
  • Biological: Corynebacterium granulosum P40
  • Procedure: adjuvant therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
Not Provided
Not Provided
Not Provided

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT00002455
ARG-CO/BR-1, CDR0000072435
Not Provided
Not Provided
Centro Oncologico de Excelencia
Not Provided
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