Cytokine-Based Immunotherapy Following High-Dose Chemotherapy and Autologous Stem Cell Transplantation
aldesleukin
+ recombinant interferon alfa
+ sargramostim
Urogenital Diseases+114
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: April 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Diagnosis of one of the following cancers and undergoing high dose chemotherapy with autologous stem cell rescue (ASCR): Metastatic breast cancer Multiple myeloma Hodgkin's disease Recurrent or refractory low, intermediate, or high grade non-Hodgkin's lymphoma Acute myelogenous leukemia beyond first remission Acute lymphoblastic leukemia beyond first remission Ovarian cancer Refractory malignancy and measurable or evaluable disease (at time of ASCR) Hormone receptor status: Not specified A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: Not specified Menopausal status: Not specified Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Midwestern Regional Medical Center
Zion, United StatesOpen Midwestern Regional Medical Center in Google Maps