Cytokine-Based Immunotherapy Following High-Dose Chemotherapy and Autologous Stem Cell Transplantation
- 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
Anastasios Raptis, MD
Cancer Treatment Centers of America
United States: Federal Government
|Midwestern Regional Medical Center||Zion, Illinois 60099|