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

NCT00005959 | Unknown Phase 2

• 3 other identifiers: CDR0000067940AMGEN-GCSF-990756NCI-V00-1593
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 27

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.

Conditions

Lymphoma

Keywords

stage III grade 3 follicular lymphoma; stage III adult diffuse small cleaved cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage III adult diffuse large cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage III adult Burkitt lymphoma; stage IV grade 3 follicular lymphoma; stage IV adult diffuse small cleaved cell lymphoma; stage IV adult diffuse mixed cell lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult immunoblastic large cell lymphoma; stage IV adult Burkitt lymphoma; contiguous stage II grade 3 follicular lymphoma; contiguous stage II adult diffuse small cleaved cell lymphoma; contiguous stage II adult diffuse mixed cell lymphoma; contiguous stage II adult immunoblastic large cell lymphoma; contiguous stage II adult diffuse large cell lymphoma; contiguous stage II adult Burkitt lymphoma; noncontiguous stage II grade 3 follicular lymphoma; noncontiguous stage II adult diffuse small cleaved cell lymphoma; noncontiguous stage II adult diffuse mixed cell lymphoma; noncontiguous stage II adult immunoblastic large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult Burkitt lymphoma

Interventions

filgrastim BIOLOGICAL

rituximab BIOLOGICAL

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

prednisone DRUG

vincristine sulfate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Amgen: lead

Study Sites (27)

Montgomery Cancer Center

Montgomery, Alabama, 36106, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Providence Saint Joseph Medical Center - Burbank

Burbank, California, 91505, United States

Location

Cancer and Blood Institute of the Desert

Rancho Mirage, California, 92270, United States

Location

Southeast Florida Hematology-Oncology Group

Fort Lauderdale, Florida, 33308, United States

Location

Oncology-Hematology Group of South Florida

Miami, Florida, 33176, United States

Location

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

Hematology-Oncology Associates, PA

Pensacola, Florida, 32501, United States

Location

Hutchinson Clinic, P.A.

Hutchinson, Kansas, 67502, United States

Location

Hematology/Oncology Care Inc.

Crestview Hills, Kentucky, 41017, United States

Location

Maine Center for Cancer Medicine and Blood Disorders

Scarborough, Maine, 04074, United States

Location

Associates in Oncology and Hematology

Rockville, Maryland, 20850, United States

Location

North Shore Cancer Center

Peabody, Massachusetts, 01960, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Lakeland Medical Center - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

Bond Clinic

Rolla, Missouri, 65401, United States

Location

Midwest Hematology Oncology Consultants, Ltd.

St Louis, Missouri, 63136, United States

Location

Hematology Oncology Associates

Morristown, New Jersey, 07962, United States

Location

New Mexico Oncology-Hematology

Albuquerque, New Mexico, 87109, United States

Location

HemOnCare, P.C.

Brooklyn, New York, 11235, United States

Location

Our Lady of Mercy Medical Center

The Bronx, New York, 10466, United States

Location

N.W. Carolina Oncology & Hematology, P.A.

Hickory, North Carolina, 28603, United States

Location

Oncology/Hematology Care, Inc.

Cincinnati, Ohio, 45219, United States

Location

University of Tennessee, Memphis

Memphis, Tennessee, 38163, United States

Location

Intermountain Hematology/Oncology Associates, Inc.

Salt Lake City, Utah, 84124, United States

Location

Vermont Center for Cancer Medicine, Inc.

Colchester, Vermont, 05446, United States

Location

Hematology & Oncology Associates of Virginia

Richmond, Virginia, 23226, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Immunoblastic; Burkitt Lymphoma

Interventions

Filgrastim; Rituximab; Cyclophosphamide; Doxorubicin; Prednisone; Vincristine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Carol Brannan, BS, BSN

  Amgen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: December 17, 2003
• Study Start: December 1, 1999
• Last Updated: December 4, 2013

Record last verified: 2002-06

Locations

US (27)