Clinical Trial: Rituximab With or Without Interleukin-12 in Treating Patients With Non-Hodgkin's Lymphoma

This study is no longer recruiting patients.

Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)


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-12 may kill cancer cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Combining rituximab with interleukin-12 may kill more cancer cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of rituximab with or without interleukin-12 in treating patients who have non-Hodgkin's lymphoma.

Condition Treatment or Intervention Phase
Waldenstrom's Macroglobulinemia
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent diffuse small lymphocytic/marginal zone lymphoma
recurrent mantle cell lymphoma
 Drug: interleukin-12
 Drug: rituximab
 Procedure: anti-cytokine therapy
 Procedure: antiangiogenesis therapy
 Procedure: antibody therapy
 Procedure: biological response modifier therapy
 Procedure: cytokine therapy
 Procedure: growth factor antagonist therapy
 Procedure: interleukin therapy
 Procedure: monoclonal antibody therapy
Phase II

MedlinePlus related topics:  Blood and Blood Disorders;   Immune System and Disorders;   Lymphatic Diseases;   Lymphoma;   Vascular Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Randomized Study of Rituximab With or Without Interleukin-12 in Patients With B-Cell Non-Hodgkin's Lymphoma

Further Study Details: 


OUTLINE: This is a randomized, multicenter study. Patients are stratified according to histology (mantle cell lymphoma vs other) and International Prognostic Factor Index (low and low-intermediate risk vs high-intermediate and high risk). Patients are randomized to 1 of 2 treatment arms.

Patients are followed every 3 months for 1 year and then every 6 months for up to 4 years.

PROJECTED ACCRUAL: A total of 90 patients (45 per treatment arm) will be accrued for this study within 3 years.


Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both



  • Histologically confirmed CD20-positive B-cell non-Hodgkin's lymphoma
  • Previously treated low-grade lymphoma considered incurable with standard therapy
  • Grade I or II follicular lymphoma
  • Lymphoplasmacytic lymphoma
  • Small lymphocytic lymphoma
  • Nodal marginal zone lymphoma
  • Extranodal marginal zone lymphoma of MALT type
  • Splenic marginal zone lymphoma
  • Previously treated mantle cell lymphoma allowed
  • Meets one of the following criteria for measurable disease:
  • Bidimensional diameter at least 1.5 cm by 1.5 cm on physical exam
  • At least 2 cm in one dimension by CT scan, MRI, or plain radiograph imaging
  • Palpable spleen at least 5 cm below the left costal margin
  • No CNS involvement by lymphoma 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.


  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 12 weeks


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 75,000/mm^3
  • Hemoglobin at least 8 g/dL


  • Bilirubin no greater than 3 times upper limit of normal (ULN)
  • AST and ALT no greater than 3 times ULN
  • Alkaline phosphatase no greater than 3 times ULN


  • Creatinine no greater than 2 times ULN


  • No New York Heart Association class III or IV heart disease
  • No history of angina


  • No uncontrolled peptic ulcer disease
  • No uncontrolled infection
  • No other active malignancy
  • No autoimmune-related phenomena (e.g., antinuclear antibody less than 2 times ULN, rheumatoid factor less than 2 times ULN, and negative direct Coombs)
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


  • Prior stem cell transplantation allowed
  • More than 12 months since prior rituximab
  • No prior interleukin-12
  • No other concurrent immunotherapy


  • Recovered from prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:


  • No concurrent radiotherapy


  • Not specified


  • Any number of prior therapies allowed

Location Information

      CCOP - Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States

      Mayo Clinic, Jacksonville,  Florida,  32224,  United States

      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States

      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61602,  United States

      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States

      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States

      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States

      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States

      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States

      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States

      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States

      CentraCare Health Plaza, Saint Cloud,  Minnesota,  56303,  United States

      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States

      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States

North Dakota
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States

      Medcenter One Health System, Bismarck,  North Dakota,  58501-5505,  United States

      CCOP - Toledo Community Hospital, Toledo,  Ohio,  43623-3456,  United States

      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States

South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States

      Rapid City Regional Hospital, Rapid City,  South Dakota,  57709,  United States

      CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay,  Wisconsin,  54301,  United States

Canada, Saskatchewan
      Allan Blair Cancer Centre, Regina,  Saskatchewan,  S4T 7T1,  Canada

Study chairs or principal investigators

Stephen M. Ansell, MD, PhD,  Study Chair,  Mayo Clinic Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068994; NCCTG-N0087
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  November 9, 2001 Identifier:  NCT00026182
Health Authority: Unspecified processed this record on 2005-04-08

Cache Date: April 9, 2005