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Combination Chemotherapy With Monoclonal Antibody Therapy in Treating Patients With Newly Diagnosed Non-Hodgkin's Lymphoma

This study is currently recruiting participants.
Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Combination Chemotherapy With Monoclonal Antibody Therapy 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
Brief 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.

Detailed Description

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 141.
  • 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)

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Active Control
Primary Outcome Measure  Compare progression-free survival rates of patients treated with CHOP chemotherapy alone, CHOP with rituximab, or CHOP followed by iodine-131 anti-CD20 antibody by Kaplan Meier survival curves at 2 or 5 years [ Designated as safety issue: No ]
Secondary Outcome Measure  Compare response rates (confirmed and unconfirmed complete and partial responses) by Cheson criteria at 4 weeks and 6 months after completion of therapy and then annually [ Designated as safety issue: No ]
Compare toxicities by NCI CTC at 4 weeks and 6 months after completion of therapy and then annually [ Designated as safety issue: Yes ]
Condition  Lymphoma
Intervention  Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: rituximab
Drug: tositumomab and iodine I 131 tositumomab
Drug: vincristine
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  500
Start Date  March 2001
Completion Date
Eligibility Criteria 

DISEASE CHARACTERISTICS:

  • Histologically confirmed previously untreated bulky stage II or stage III or IV follicular non-Hodgkin's lymphoma

    • Grade I-III disease
  • CD20 antigen positive
  • Fewer than 5,000/mm^3 circulating lymphoid cells on a WBC differential count
  • Bidimensionally measurable disease
  • Bone marrow aspiration and biopsy within the past 42 days
  • No clinical evidence of 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/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • No impaired cardiac status, including:

    • Severe coronary artery disease
    • Cardiomyopathy
    • Congestive heart failure
    • Serious arrhythmia
  • Ejection fraction at least lower limit of normal by MUGA or 2-D echocardiogram for questionable cardiac history

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:

  • No prior monoclonal antibodies for cancer

Chemotherapy:

  • No prior chemotherapy for lymphoma

    • Prior prednisone for non-lymphoma related illnesses allowed

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy for lymphoma

Surgery:

  • See Disease Characteristics
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00006721
Organization ID CDR0000068321
Secondary IDs †† SWOG-S0016, CALGB-50102, ECOG-SWOG-S0016
Study Sponsor  Southwest Oncology Group
Collaborators †† National Cancer Institute (NCI)
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
Investigators 
Study Chair:     Oliver W. Press, MD, PhD     Fred Hutchinson Cancer Research Center    
Study Chair:     Myron S. Czuczman, MD     Roswell Park Cancer Institute    
Study Chair:     Sandra J. Horning, MD     Stanford University    
Information Provided By National Cancer Institute (NCI)
Verification Date July 2008
First Received Date  December 6, 2000
Last Updated Date July 3, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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