Rituximab in Treating Patients With Hodgkin's Lymphoma

Not Recruiting

Trial ID: NCT00003820

Purpose

Phase 2 trial to study the effectiveness of rituximab in treating patients who have lymphocyte-predominant Hodgkin's lymphoma.

Official Title

Phase 2 Trial to Evaluate the Efficacy of Anti-CD20 Antibody in Patients With Lymphocyte Predominant Hodgkin's Disease

Stanford Investigator(s)

Richard Hoppe
Richard Hoppe

Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology

Eligibility

INCLUSION CRITERIA

* Age ≥ 3 years
* Lymphocyte-predominant Hodgkin's disease (LPHD) of B-cell lineage
* Biopsy-confirmed expression of CD20 antigen
* At least one tumor mass measuring \> 1.0 cm in largest dimension
* No evidence of active infection
* Subjects at high risk of Hepatitis B virus (HBV) infection should be screened prior to enrollment.
* Performance status of 0 to 2
* Absolute neutrophil count (ANC) \> 1500/mL
* Platelet count \> 50,000/mL
* Serum creatinine (Cr) \< 1.5 x upper limit of normal (ULN)
* Alkaline phosphatase \< 2 x ULN, unless related to primary disease
* Bilirubin \< 2 x ULN, unless related to primary disease
* Aspartate transaminase (AST) and alanine transaminase (ALT) \< 2 x ULN, unless related to primary disease
* Subjects must be able to read and sign Institutional Review Board-approved informed consent

EXCLUSION CRITERIA

* Life expectancy at least 12 weeks
* Evidence of other active malignancies other than cured carcinomas in situ of the cervix or basal cell carcinoma of the skin
* Active HBV infection or hepatitis.
* Serious non-malignant disease (eg, congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections)
* Concomitant or treatment within prior 4 weeks with radiotherapy or chemotherapy (within prior 6 weeks for nitrosourea compounds)
* Concurrent treatment with prednisone or other systemic steroid medication
* Treatment with any investigational drug within 30 days prior to entry into the study
* Treatment with any investigational drug within 5 half-lives of that drug prior to entry into the study
* Major surgery, other than diagnostic surgery, within 4 weeks
* Any other conditions which, in the opinion of the investigator and/or sponsor, would compromise other protocol objectives
* Female patients must be of non-childbearing potential or using adequate contraception with a negative pregnancy test at study entry

Intervention(s):

drug: Rituximab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sarah Daadi
6507256456

New Trial Alerts