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

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	No Study Results Posted


	Related Studies

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

This study is ongoing, but not recruiting participants.

Study NCT00002455. Last updated on July 23, 2008. Information provided by National Cancer Institute (NCI)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

Immunotherapy of Colon Cancer With Autologous Perchloric Soluble Tumors Extracts

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.

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

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment

Primary Outcome Measure ^†

Recurrence [ Designated as safety issue: No ]
Response to study parameters [ Designated as safety issue: No ]
Survival rate [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Condition ^†

Breast Cancer
Colorectal Cancer
Melanoma (Skin)

Intervention ^†

Drug: Corynebacterium granulosum P40
Procedure: adjuvant therapy

MEDLINE PMIDs

Links

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

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Start Date ^†

April 1971

Completion Date

Eligibility 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

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Argentina

Administrative Information Fields

NCT ID ^†

NCT00002455

Organization ID

CDR0000072435

Secondary IDs ^††

ARG-CO/BR-1

Study Sponsor ^†

Centro Oncologico de Excelencia

Collaborators ^††

Investigators ^†

Study Chair:

Hugo Omar De Carli, MD

Centro Oncologico de Excelencia

Information Provided By

National Cancer Institute (NCI)

Verification Date

November 1998

First Received Date ^†

November 1, 1999

Last Updated Date

July 23, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.