Combination Chemotherapy Plus Rituximab in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma

Sponsor

Amgen (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00005959

Collaborator

(none)

Locations

Study Details

Study Description

Brief Summary

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. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with rituximab may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of rituximab plus combination chemotherapy in treating patients who have intermediate-grade or high-grade non-Hodgkin's lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Biological: filgrastim Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate	Phase 2

Detailed Description

OBJECTIVES: I. Determine the rate of complete response and partial response in patients with intermediate or high grade non-Hodgkin's lymphoma treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). II. Determine the toxicity of this regimen in these patients. III. Determine the disease-free and overall survival, time to response, and time to disease progression in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to the number of risk factors (0-2 vs 3-5). Risk factors include age (no greater than 60 vs greater than 60), tumor stage (II vs III or IV), number of extranodal sites (no more than 1 vs more than 1), performance status (0-1 vs 2-4), and serum LDH level (no greater than normal vs greater than normal). Patients receive rituximab IV on day 1; cyclophosphamide, doxorubicin, and vincristine IV on day 3; and oral prednisone on days 3-7. Patients over 60 also receive filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing until blood counts recover (all other patients receive G-CSF as secondary prophylaxis). Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who respond receive 2 more courses. Patients who have no measurable disease after 6 courses receive rituximab IV once weekly for 4 consecutive weeks. This treatment continues every 6 months for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who have measurable disease after 6 courses of chemotherapy receive 2 more courses for a maximum of 8 courses of CHOP, followed by maintenance therapy with rituximab (as described above). Patients are followed every 6 months for 2 years.

PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

Phase II Trial of Rituximab in Combination With CHOP Chemotherapy in Patients With Previously Untreated Intermediate or High Grade Non-Hodgkin's Lymphoma

Study Start Date :

Dec 1, 1999

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS: Histologically confirmed intermediate or high grade non-Hodgkin's lymphoma Stage II, III, or IV disease B-cell where lymphoid cells are CD20 or CD19 positive No mantle cell, lymphoblastic, or peripheral T-cell non-Hodgkin's lymphoma Measurable or evaluable disease No prior treatment for lymphoma No known CNS metastases 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 60-100% Life expectancy: At least 12 weeks Hematopoietic: Unless documented bone marrow disease:

Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic:

SGOT and SGPT no greater than 3 times upper limit of normal Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No history of severe heart disease, cardiomyopathy, or congestive heart failure LVEF normal by MUGA or echocardiogram Other: Not pregnant or nursing Fertile patients must use effective contraception No active infection as defined by: Clinical syndrome consistent with a viral or bacterial infection (e.g., influenza, upper respiratory infection, urinary tract infection) OR Fever with a clinical site of infection identified OR Microbiologically documented infection, including, but not limited to, bacteremia or septicemia No known HIV positivity No known sensitivity to E. coli derivatives (e.g., asparaginase, human insulin, human growth hormone, interferon alfa-2b) No other prior malignancy within the past 5 years except surgically cured basal or squamous cell skin cancer or carcinoma in situ of the cervix No psychiatric, addictive, or other disorder that may preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No concurrent biologic therapy except epoetin alfa No white blood cell transfusions Chemotherapy: See Disease Characteristics No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No concurrent radiotherapy Surgery: At least 2 weeks since prior major surgery Other: No other concurrent investigational therapy No prophylactic antibiotics

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montgomery Cancer Center	Montgomery	Alabama	United States	36106
2	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
3	Providence Saint Joseph Medical Center - Burbank	Burbank	California	United States	91505
4	Cancer and Blood Institute of the Desert	Rancho Mirage	California	United States	92270
5	Southeast Florida Hematology-Oncology Group	Fort Lauderdale	Florida	United States	33308
6	Mount Sinai Comprehensive Cancer Center	Miami Beach	Florida	United States	33140
7	Oncology-Hematology Group of South Florida	Miami	Florida	United States	33176
8	Hematology-Oncology Associates, PA	Pensacola	Florida	United States	32501
9	Hutchinson Clinic, P.A.	Hutchinson	Kansas	United States	67502
10	Hematology/Oncology Care Inc.	Crestview Hills	Kentucky	United States	41017
11	Maine Center for Cancer Medicine and Blood Disorders	Scarborough	Maine	United States	04074
12	Associates in Oncology and Hematology	Rockville	Maryland	United States	20850
13	North Shore Cancer Center	Peabody	Massachusetts	United States	01960
14	Henry Ford Hospital	Detroit	Michigan	United States	48202
15	Lakeland Medical Center - St. Joseph	Saint Joseph	Michigan	United States	49085
16	Bond Clinic	Rolla	Missouri	United States	65401
17	Midwest Hematology Oncology Consultants, Ltd.	Saint Louis	Missouri	United States	63136
18	Hematology Oncology Associates	Morristown	New Jersey	United States	07962
19	New Mexico Oncology-Hematology	Albuquerque	New Mexico	United States	87109
20	Our Lady of Mercy Medical Center	Bronx	New York	United States	10466
21	HemOnCare, P.C.	Brooklyn	New York	United States	11235
22	N.W. Carolina Oncology & Hematology, P.A.	Hickory	North Carolina	United States	28603
23	Oncology/Hematology Care, Inc.	Cincinnati	Ohio	United States	45219
24	University of Tennessee, Memphis	Memphis	Tennessee	United States	38163
25	Intermountain Hematology/Oncology Associates, Inc.	Salt Lake City	Utah	United States	84124
26	Vermont Center for Cancer Medicine, Inc.	Colchester	Vermont	United States	05446
27	Hematology & Oncology Associates of Virginia	Richmond	Virginia	United States	23226