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Comparison of Biological Therapies Following Combination Chemotherapy and Bone Marrow or Peripheral Stem Cell Transplantation in Women With Stage II or Stage III Breast Cancer

NCT00008203 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2013-02-04

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Biological therapy may interfere with the growth of the cancer cells. It is not yet known which post-transplant biological therapy regimen is more effective for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of cyclosporine and interferon gamma to that of interleukin-2 following combination chemotherapy and bone marrow or peripheral stem cell transplantation in women who have stage II or stage III breast cancer.

Conditions

Interventions

BIOLOGICAL

aldesleukin

BIOLOGICAL

recombinant interferon gamma

DRUG

carboplatin

DRUG

cyclophosphamide

DRUG

cyclosporine

DRUG

thiotepa

PROCEDURE

autologous bone marrow transplantation

PROCEDURE

peripheral blood stem cell transplantation

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Herbert Irving Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Charles S. Hesdorffer, MD · Herbert Irving Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-05-31
Primary Completion
2005-12-31
Completion
2008-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00008203 on ClinicalTrials.gov