NCT00002455

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1971

Completed
28.6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

August 7, 2013

Status Verified

November 1, 1998

First QC Date

November 1, 1999

Last Update Submit

August 6, 2013

Conditions

Breast CancerColorectal CancerMelanoma (Skin)

Keywords

stage I colon cancerstage II colon cancerstage III colon cancerstage I breast cancerstage II breast cancerstage IIIA breast cancerrecurrent breast cancerrecurrent colon cancerstage I melanomastage II melanomastage III melanomarecurrent melanoma

Outcome Measures

Primary Outcomes (3)

  • Recurrence

  • Response to study parameters

  • Survival rate

Interventions

Corynebacterium granulosum P40BIOLOGICAL
adjuvant therapyPROCEDURE

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Centro Oncologico de Excelencia

Manuel B. Gonnet, Buenos Aires, 1987 MB, Argentina

Location

Related Publications (1)

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

    BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsMelanomaColonic Neoplasms

Interventions

Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin Neoplasms

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Hugo Omar De Carli, MD

    Centro Oncologico de Excelencia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

April 1, 1971

Last Updated

August 7, 2013

Record last verified: 1998-11

Locations

AR(1)