Breast Cancer Clinical Trial
Official title:
Cytokine-Based Immunotherapy Following High-Dose Chemotherapy and Autologous Stem Cell Transplantation
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop
cancer cells from growing. Combining chemotherapy and peripheral stem cell transplantation
with biological therapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of biological therapy with sargramostim,
interleukin-2, and interferon alfa following chemotherapy and peripheral stem cell
transplantation in treating patients who have cancer.
OBJECTIVES:
- Determine the feasibility of therapy with sargramostim (GM-CSF), interleukin-2 and
interferon alfa following high dose chemotherapy and autologous stem cell rescue in
patients with high risk cancer.
- Determine the effect of this regimen on long-term leukocyte and platelet recovery
following high dose chemotherapy and stem cell rescue in these patients.
- Determine the cellular response to this regimen in these patients.
- Assess progression free and overall survival rates in these patients.
OUTLINE: This is a dose escalation study of interleukin-2 and interferon alfa.
Beginning 14 days after the autologous stem cell transplant, patients receive daily
subcutaneous injections of sargramostim (GM-CSF) on days 1-7 and daily intravenous
interleukin-2 on days 3-7, followed by 1 week of rest. Patients then receive a subcutaneous
injection of interferon alfa three times a week for 3 weeks followed by one more week of
rest. Treatment is repeated for four courses.
Cohorts of 10 patients each receive escalating doses of interleukin-2 and interferon alfa
until a maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which
no more than 3 of 10 patients experience dose limiting toxicity. Intrapatient dose
escalation occurs in courses 2-4, in the absence of dose limiting toxicity.
PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.
;
Primary Purpose: Treatment
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