Suspended

Immunotherapy of Colon Cancer With Autologous Perchloric Soluble Tumors Extracts

What is being tested

Corynebacterium granulosum P40

+ adjuvant therapy

BiologicalProcedure

Who is being recruted

Breast Diseases+21

+ Colonic Diseases

+ Digestive System Diseases

From 20 to 80 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: April 1971

See protocol details

Summary

Principal SponsorCentro Oncologico de Excelencia

Last updated: August 7, 2013

Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1971

Actual date on which the first participant was enrolled.

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

NCT00002455

Principal SponsorCentro Oncologico de Excelencia

Last updated: August 7, 2013

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesColonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueRectal DiseasesSkin DiseasesSkin NeoplasmsSkin and Connective Tissue DiseasesNeuroectodermal TumorsNevi and MelanomasNeuroendocrine TumorsBreast NeoplasmsColonic NeoplasmsMelanomaColorectal Neoplasms

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Centro Oncologico de Excelencia

Manuel B. Gonnet, ArgentinaOpen Centro Oncologico de Excelencia in Google Maps

SuspendedOne Study Center