Dose Finding Study of Toxicity and Immunomodulatory Effects of Interleukin-2 Following Allogeneic Bone Marrow Transplantation in Patients at High Risk for Relapse
aldesleukin
Blood Protein Disorders+49
+ Bone Marrow Diseases
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: April 1, 1998
Actual date on which the first participant was enrolled.OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of interleukin-2 following allogeneic T-cell depleted bone marrow transplant in patients with hematologic malignancies at high risk of relapse. II. Determine the optimal dose of interleukin-2 in this regimen which will result in maximal natural killer cell and lymphokine activated killer cell activity in vitro. OUTLINE: This is a dose escalation study. Patients receive CD34+ stem cell augmented donor bone marrow on day 0 on another protocol. Patients then receive interleukin-2 (IL-2) subcutaneously on day 30. Treatment continues for 12 weeks in the absence of dose limiting toxicity. Cohorts of 4 patients receive escalating doses of IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose prior to that which causes at least grade 3 toxicity. PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 12-18 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.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.Until 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Any of the following diagnoses eligible: Acute myelogenous leukemia beyond first complete remission Acute lymphoblastic leukemia Chemotherapy resistant non-Hodgkin's lymphoma Chemotherapy resistant Hodgkin's disease Multiple myeloma Primary refractory acute leukemia Secondary leukemia Chronic myelomonocytic leukemia No chronic myelogenous leukemia, aplastic anemia, or myelofibrosis HLA identical related donor required PATIENT CHARACTERISTICS: Age: 0.5 to 65 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characterisitics Hepatic: Bilirubin less than 2.5 mg/dL (unless Gilbert's syndrome present) Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No active congestive heart failure, arrhythmia, or angina pectoris No myocardial infarction within past 12 months Pulmonary: No requirement for oxygen Other: Afebrile for greater than 48 hours No active, serious infection (e.g., sepsis, mucormycosis, or uncontrolled aspergillosis) No debilitating medical or psychiatric illness that would preclude compliance Not pregnant Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplant Chemotherapy: See Disease Characteristics Endocrine therapy: No concurrent corticosteroids 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
Johns Hopkins Oncology Center
Baltimore, United StatesOpen Johns Hopkins Oncology Center in Google Maps