Dose Finding Study of Toxicity and Immunomodulatory Effects of Interleukin-2 Following Allogeneic Bone Marrow Transplantation in Patients at High Risk for Relapse
N/A
65 Years
Both
Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
Dose Finding Study of Toxicity and Immunomodulatory Effects of Interleukin-2 Following Allogeneic Bone Marrow Transplantation in Patients at High Risk for Relapse
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Paul V. O'Donnell, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Fred Hutchinson Cancer Research Center
Authority:
United States: Federal Government
Study ID:
CDR0000067162
NCT ID:
NCT00003962
Start Date:
April 1998
Completion Date:
Related Keywords:
- Leukemia
- Lymphoma
- Multiple Myeloma and Plasma Cell Neoplasm
- recurrent childhood acute lymphoblastic leukemia
- recurrent adult Hodgkin lymphoma
- refractory multiple myeloma
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- recurrent childhood lymphoblastic lymphoma
- recurrent childhood acute myeloid leukemia
- recurrent adult acute myeloid leukemia
- recurrent adult acute lymphoblastic leukemia
- recurrent/refractory childhood Hodgkin lymphoma
- chronic myelomonocytic leukemia
- acute undifferentiated leukemia
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent adult T-cell leukemia/lymphoma
- secondary acute myeloid leukemia
- AIDS-related peripheral/systemic lymphoma
- recurrent childhood small noncleaved cell lymphoma
- recurrent childhood large cell lymphoma
- recurrent mantle cell lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- Neoplasms
- Leukemia
- Lymphoma
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
Name | Location |
|---|---|
| Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
