High-Dose Chemotherapy Followed By Autologous Hematopoietic Stem Cell Support And One Of Two Regimens Aimed At Modifying Immune Reconstitution In Women With High Risk Stage 2 And Stage 3 Breast Cancer
- Determine the response, disease-free survival (DFS), and overall survival of women with
high-risk stage II or III breast cancer treated with high-dose cyclophosphamide,
thiotepa, and carboplatin with autologous marrow and/or peripheral blood stem cell
- Determine the safety of immunomodulation consisting of cyclosporine and interferon
gamma versus low-dose interleukin-2 in this patient population.
- Determine parameters associated with immune activation and autologous graft-versus-host
- Determine which immunomodulation regimen is more efficacious with respect to DSF.
OUTLINE: This is a randomized study. Patients are stratified according to stage (II vs III),
age, lymph node status, and inflammatory histology. Patients are randomized to one of two
Autologous harvest of at least 1 million CD34+ cells /kg or 400 million mononuclear cells/kg
must be achieved.
All patients receive cyclophosphamide IV continuously and thiotepa IV continuously over 96
hours on days -6 through -3 and carboplatin IV over 5 hours daily on days -6 through -3.
Patients undergo autologous bone marrow and/or peripheral blood stem cell transfusion on day
- Arm I: Patients receive cyclosporine IV over 4 hours twice a day, beginning on day 0
and continuing until discharge from the hospital, and interferon gamma subcutaneously
(SC) every 2 days on days 7-28.
- Arm II: Patients receive interleukin-2 SC daily for 28 days following recovery of blood
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then annually for 5 years.
PROJECTED ACCRUAL: A total of 70 patients (30 with stage II disease and 40 with stage III
disease) will be accrued over 2 years.
Allocation: Randomized, Primary Purpose: Treatment
Charles S. Hesdorffer, MD
Herbert Irving Comprehensive Cancer Center
United States: Federal Government
|Herbert Irving Comprehensive Cancer Center||New York, New York 10032|