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

Trial Information

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

OBJECTIVES:

- 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
transplantation.

- 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
disease.

- 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
immunomodulation arms.

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
0.

- 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
counts.

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.