Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells. It is not yet known which monoclonal antibody plus combination chemotherapy regimen is more effective in treating non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is comparing 2 different monoclonal antibodies given together with combination chemotherapy to see how well they work in treating patients with newly-diagnosed non-Hodgkin's lymphoma.

Official Title

A Phase III Trial of CHOP Plus Rituximab vs CHOP Plus Iodine-131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) for Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas

Details

OBJECTIVES:

  • Compare the progression-free survival and overall survival of patients with newly diagnosed follicular non-Hodgkin's lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) with or without either rituximab or iodine I 131 tositumomab (monoclonal antibody anti-B1). (CHOP chemotherapy alone arm closed to accrual as of 12/15/02)
  • Compare the response rate of these patients treated with these regimens.
  • Compare the toxic effects of these regimens in these patients.
  • Compare the molecular remission rates of this patient population treated with these regimens.
  • Determine the incidence and time to development of human anti-mouse antibody positivity.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to whether microglobulin is greater than upper limit of normal (yes vs no). Patients are randomized to 1 of 3 treatment arms. (Arm I closed to accrual as of 12/15/02)

  • Arm I (CHOP only): Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
  • Arm II (CHOP + rituximab): Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and
  • Arm III (CHOP + tositumomab): Patients receive chemotherapy as in arm I and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141.

Patients are followed on day 200, at 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 500 patients (250 per treatment arm) will be accrued for this study within 5.5 years. (Arm I closed to accrual as of 12/15/02)

Keywords

Lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, Non-Hodgkin Lymphoma, Prednisone, Cyclophosphamide, Rituximab, Doxorubicin, Vincristine, tositumomab, CHOP + rituximab, CHOP + tositumomab

Eligibility

For people ages 18 years and up

DISEASE CHARACTERISTICS:

  • Histologically confirmed previously untreated bulky stage II or stage III or IV follicular non-Hodgkin's lymphoma
    • Grade I-III disease
  • Cluster of differentiation antigen 20 (CD20) antigen positive
  • Fewer than 5,000/mm3 circulating lymphoid cells on a white blood cell (WBC) differential count
  • Bidimensionally measurable disease
  • Bone marrow aspiration and biopsy within the past 42 days
  • No clinical evidence of central nervous system (CNS) involvement by lymphoma

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics
  • Granulocyte count greater than 1,500/mm3
  • Platelet count greater than 100,000/mm3

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

Other:

  • No hypersensitivity to iodine
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 6 months after study participation
  • HIV negative
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Chemotherapy:

  • No prior chemotherapy for lymphoma
    • Prior prednisone for non-lymphoma related illnesses allowed

Endocrine therapy:

  • Not specified

Radiotherapy:

Surgery:

  • See Disease Characteristics

Locations

  • University of California Davis Cancer Center
    Sacramento California 95817 United States
  • California Pacific Medical Center - California Campus
    San Francisco California 94118 United States
  • Alta Bates Summit Comprehensive Cancer Center
    Berkeley California 94704 United States
  • Marin Cancer Institute at Marin General Hospital
    Greenbrae California 94904 United States
  • Sutter Health - Western Division Cancer Research Group
    Greenbrae California 94904 United States
  • Peninsula Medical Center
    Burlingame California 94010 United States
  • Stanford Cancer Center
    Stanford California 94305-5824 United States
  • Sutter Solano Medical Center
    Vallejo California 94589 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
SWOG Cancer Research Network
ID
NCT00006721
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 571 people participating
Last Updated