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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 1998 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002455
First Posted: January 27, 2003
Last Update Posted: August 7, 2013
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.
Information provided by:
National Cancer Institute (NCI)
  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 3

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:


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

Primary Outcome Measures:
  • Recurrence
  • Response to study parameters
  • Survival rate

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Publications:
De Carli HO: Immunostimulation and follow-up in long term subclinical cancer. Buenos Aires. Argentina: Centro Oncologico de Excelencia.

ClinicalTrials.gov Identifier: NCT00002455     History of Changes
Other Study ID Numbers: ARG-CO/BR-1
CDR0000072435 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: November 1, 1999
First Posted: January 27, 2003
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
Melanoma
Colorectal Neoplasms
Colonic Neoplasms
Neoplasms by Site
Neoplasms
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