drugset / Trial / NCT00008203

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

RandomizedTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclosporine Peptide 1.25 mg/kg Intravenous
Subject Interferon gamma-1b Protein / enzyme biologic 0.025 mg/m2 Subcutaneous
Subject aldesleukin Protein / enzyme biologic 1e+06 unknown Subcutaneous
Background Carboplatin Small molecule Intravenous
Background Cyclophosphamide Other / unclassified Intravenous
Background Thiotepa Other / unclassified Intravenous