CHOP-Rituximab Augmented With GM-CSF in Patients With Previously Untreated Diffuse Large B Cell Non-Hodgkin's Lymphoma

• Status: Terminated
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary goal of this study is to determine the effects (good and bad) of Granulocyte-macrophage colony stimulating factor (GM-CSF) in combination with Cytoxan, Adriamycin, Vincristine, Prednisone, Rituximab (CHOP-R) on diffuse Large B cell Non-Hodgkin's lymphoma (DLBCL). The standard of care for DLBCL is the combination of drugs known as CHOP-Rituximab (CHOP-R). The drugs that make up CHOP-R are the chemotherapy drugs cyclophosphamide, doxorubicin and vincristine, prednisone and rituximab. GM-CSF is a drug that stimulates the immune system by increasing the numbers of white blood cells. Previous research has shown that GM-CSF might help rituximab to be more effective in treating lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Bayer; Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Dana-Farber Cancer Institute
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• Histologically confirmed diagnosis of diffuse large B cell Non-Hodgkin's lymphoma with characteristic immunophenotypic profile

• Patient has not received any prior anti-cancer therapy for lymphoma

• Tumor tissue confirmed to express the cluster of differentiation antigen 20 antigen by flow cytometry or immunohistochemistry

• Measurable disease as defined by a tumor mass of 1cm or greater in one dimension

• Stage II (abdominal-not radiotherapy appropriate), III, or IV disease

• Age > 18 years

• Performance Status of 0-2

• Laboratory parameters as outlined in protocol

• Patient agrees to use birth control

Exclusion Criteria:

• Known central nervous system involvement by lymphoma

• Serious uncontrolled concurrent illness such as active coronary artery disease, severe lung disease, heart failure, active alcohol abuse, active concurrent malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix

• Any evidence of prior natural exposure to Hepatitis B

• Active rheumatologic disease which may be exacerbated by GM-CSF

• Cardiac ejection fraction less than 45%

• Known HIV disease

• Patient is pregnant or nursing

• Patient is receiving other investigational drugs