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Interleukin-2 Following Bone Marrow Transplantation in Treating Patients With Hematologic Cancer

This study has been completed.

Sponsors and Collaborators: Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003962
  Purpose

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.

PURPOSE: Phase I trial to study the effectiveness of interleukin-2 following bone marrow transplantation in treating patients who have hematologic cancer at risk of relapse.


Condition Intervention Phase
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Drug: aldesleukin
Phase I

Genetics Home Reference related topics:   aceruloplasminemia    hemophilia   

MedlinePlus related topics:   Bone Marrow Transplantation    Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood    Lymphoma    Multiple Myeloma   

ChemIDplus related topics:   Aldesleukin    Interleukin-2   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Dose Finding Study of Toxicity and Immunomodulatory Effects of Interleukin-2 Following Allogeneic Bone Marrow Transplantation in Patients at High Risk for Relapse

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   April 1998

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003962

Locations
United States, Maryland
Johns Hopkins Oncology Center    
      Baltimore, Maryland, United States, 21287

Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Paul V. O'Donnell, MD, PhD     Fred Hutchinson Cancer Research Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067162, JHOC-98040902, JHOC-J9825, NCI-H99-0033
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003962
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent childhood acute lymphoblastic leukemia  
recurrent adult Hodgkin lymphoma  
refractory plasma cell neoplasm  
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

Study placed in the following topic categories:
Chronic myelomonocytic leukemia
Lymphoma, Mantle-Cell
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Small non-cleaved cell lymphoma
Lymphoma, large-cell, immunoblastic
Hemorrhagic Disorders
Multiple myeloma
Neoplasm Metastasis
Acute myeloid leukemia, adult
Hodgkin Disease
Lymphoma, Large B-Cell, Diffuse
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Blood Coagulation Disorders
Leukemia, B-cell, chronic
Acute myelogenous leukemia
Leukemia, Myeloid
Multiple Myeloma
Aldesleukin
Hodgkin lymphoma, childhood
B-cell lymphomas
Leukemia, T-Cell
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Hodgkin's disease
Hematologic Neoplasms
Blood Protein Disorders

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-HIV Agents
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Antiviral Agents
Pharmacologic Actions
Neoplasms
Anti-Retroviral Agents
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Cardiovascular Diseases
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2008




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