Rituximab Followed by Combination Chemotherapy in Treating Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma

NCT00006669 | Withdrawn Phase 2

• 3 other identifiers: CDR0000068283WHC-99365NCI-V00-1630
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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 kill cancer cells. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of rituximab followed by combination chemotherapy in treating patients who have refractory or recurrent non-Hodgkin's lymphoma.

Conditions

Lymphoma

Keywords

recurrent grade 3 follicular lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse large cell lymphoma

Interventions

rituximab BIOLOGICAL

sargramostim BIOLOGICAL

EPOCH regimen DRUG

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

etoposide DRUG

prednisone DRUG

vincristine sulfate DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Diagnosis of intermediate grade B-cell CD20+ non-Hodgkin's lymphoma Failed to achieve initial complete response (CR) after at least 2 courses of standard chemotherapy OR Relapsed after CR and not eligible for autologous bone marrow transplant Measurable disease defined as one of the following: Bidimensionally measurable disease at least 2 cm in diameter by radiograph or CT scan Enlarged spleen extending at least 2 cm below the costal due to lymphomatous involvement Enlarged liver with focal lesions on CT scan or biopsy proven lesions Lymphomatous hepatic involvement must be biopsy proven for the liver to be sole area of measurable disease No evidence of CNS involvement 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: ECOG 0-3 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3\* Platelet count at least 100,000/mm3\* \*unless there is bone marrow involvement with lymphoma Hepatic: Bilirubin less than 3 mg/dL AST/ALT less than 2 times normal Renal: Creatinine less than 2.1 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: LVEF greater than 45% by MUGA or echocardiogram Other: No prior malignancy within the past 10 years except squamous cell carcinoma or basal cell carcinoma of the skin or cervical cancer No evidence of infection HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior rituximab

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

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (2)

Washington Cancer Institute

Washington D.C., District of Columbia, 20010, United States

Location

Franklin Square Hospital Center

Baltimore, Maryland, 21237, United States

Location

MeSH Terms

Conditions

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

Interventions

Rituximab; sargramostim; EPOCH protocol; Cyclophosphamide; Doxorubicin; Etoposide; 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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and 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; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; 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

• Sein Aung, MD

  Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2000
• First Posted: May 4, 2004
• Study Start: September 1, 1999
• Primary Completion: January 1, 2000
• Study Completion: January 1, 2000
• Last Updated: October 27, 2021

Record last verified: 2001-05

Locations

US (2)