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

NCT ID: NCT00002455

Last Updated: 2013-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

1971-04-30

Brief Summary

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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

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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

Conditions

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Breast Cancer Colorectal Cancer Melanoma (Skin)

Keywords

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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

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Corynebacterium granulosum P40

Intervention Type BIOLOGICAL

adjuvant therapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Oncologico de Excelencia

OTHER

Sponsor Role lead

Principal Investigators

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Hugo Omar De Carli, MD

Role: STUDY_CHAIR

Centro Oncologico de Excelencia

Locations

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Centro Oncologico de Excelencia

Manuel B. Gonnet, Buenos Aires, Argentina

Site Status

Countries

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Argentina

References

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

Reference Type BACKGROUND

Other Identifiers

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CDR0000072435

Identifier Type: REGISTRY

Identifier Source: secondary_id

ARG-CO/BR-1

Identifier Type: -

Identifier Source: org_study_id