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Dose Finding Study of Toxicity and Immunomodulatory Effects of Interleukin-2 Following Allogeneic Bone Marrow Transplantation in Patients at High Risk for Relapse

Phase 1
65 Years
Not Enrolling
Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm

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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

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

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:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Paul V. O'Donnell, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center


United States: Federal Government

Study ID:




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



Johns Hopkins Oncology Center Baltimore, Maryland  21287