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Rituximab Plus Interleukin-2 in Treating Patients With Hematologic Cancer
This study is ongoing, but not recruiting participants.
Study NCT00010192   Information provided by National Cancer Institute (NCI)
First Received: February 2, 2001   Last Updated: February 6, 2009   History of Changes

February 2, 2001
February 6, 2009
December 2000
 
 
 
Complete list of historical versions of study NCT00010192 on ClinicalTrials.gov Archive Site
 
 
 
Rituximab Plus Interleukin-2 in Treating Patients With Hematologic Cancer
A Phase I Trial Of Rituximab And Interleukin-2

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining rituximab with interleukin-2 may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of rituximab plus interleukin-2 in treating patients who have hematologic cancer.

OBJECTIVES:

  • Determine the dose-limiting toxicity of rituximab followed by low-dose and intermediate-dose pulse interleukin-2 (IL-2) in patients with CD20-positive B-cell lymphoid malignancy.
  • Determine the maximum tolerated dose of intermediate-dose pulse IL-2 in this patient population.
  • Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a dose-escalation study of intermediate-dose pulse interleukin-2 (IL-2).

Patients receive rituximab IV on days 1, 8, 15, and 22. Patients then receive low-dose IL-2 subcutaneously (SC) on days 29-39, 43-53, 57-67, and 71-81, and intermediate-dose IL-2 SC on days 40-42, 54-56, 68-70, and 82-84.

Cohorts of 3-6 patients receive escalating doses of intermediate-dose pulse IL-2 until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 1 year.

Phase I
Interventional
Treatment
  • Leukemia
  • Lymphoma
  • Biological: aldesleukin
  • Biological: rituximab
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically or immunophenotypically proven CD20-positive B-cell lymphoproliferative disorder

    • Recurrent or progressive low-grade B-cell lymphoma with at least one prior chemotherapy regimen (may have included monoclonal antibody)
    • Relapsed intermediate-grade or high-grade B-cell lymphoma or B-lineage acute lymphoblastic leukemia and patient not a candidate for, refused, or failed prior hematopoietic stem cell transplantation
  • No chronic lymphocytic leukemia or lymphoma with more than 5,000/mm3 circulating lymphoma cells
  • Measurable or evaluable disease
  • Must have failed standard curative therapy
  • No CNS or leptomeningeal metastasis NOTE: 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:

  • 18 and over

Performance status:

  • Karnofsky 70-100% OR
  • ECOG 0-1

Life expectancy:

  • At least 4 months

Hematopoietic:

  • Absolute neutrophil count at least 1,000/mm^3
  • Hemoglobin at least 10 g/dL (transfusion allowed)
  • Platelet count at least 50,000/mm^3

Hepatic:

  • AST no greater than upper limit of normal (ULN)
  • Bilirubin no greater than 1.5 times ULN
  • Hepatitis B surface antigen negative

Renal:

  • Creatinine no greater than ULN

Cardiovascular:

  • No prior unstable coronary artery disease
  • No New York Heart Association class III or IV congestive heart failure

Pulmonary:

  • DLCO and FEV1 at least 50% of predicted

Other:

  • HIV negative
  • No other concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No infection requiring IV antibiotic therapy within the past 4 weeks
  • No other major illness that would preclude study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • Prior antibody therapy allowed
  • Prior interleukin-2 or interferon alfa allowed

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy

Endocrine therapy:

  • At least 4 weeks since prior systemic corticosteroids

Radiotherapy:

  • At least 4 weeks since prior radiotherapy

Surgery:

  • At least 4 weeks since prior surgery
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00010192
 
CDR0000068454, OSU-00H0223, OSU-0037, NCI-130
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
Study Chair: Pierluigi Porcu, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
October 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP