Rituximab and ABVD for Hodgkin's Patients

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

• To determine the feasibility, toxicity, and efficacy of Rituximab with standard dose ABVD combination chemotherapy.

ABVD combination chemotherapy consists of Adriamycin, Bleomycin, Vinblastine and DTIC.

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

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Genentech, Inc.
• Treatments: Bleomycin; Dacarbazine; Doxorubicin; Liposomal doxorubicin; Rituximab; Vinblastine

Criteria

Inclusion Criteria:

1. Hodgkin's disease patients who relapse after radiation therapy alone and previously untreated patients with stage II bulky, III and IV who are eligible for ABVD.

2. Must have histologically proven diagnosis of Hodgkin's disease (Nodular sclerosis or mixed cellularity).

3. Must have bidimensionally measurable disease.

4. Must sign a consent form.

5. Must be older than 16 years of age.

6. Must have adequate bone marrow reserve (ANC > 1,000/microL, Platelet > 100,000/microL

7. Left Ventricular Ejection Fraction (LVEF) >/= 50% by multigated acquisition (MUGA) scan or echocardiogram.

8. Serum creatinine < 2 mg/dl, serum bilirubin < 2 mg/dl

Exclusion Criteria:

1. HIV positive.

2. Pregnant women and women of child bearing age who are not practicing adequate contraception.

3. Prior chemotherapy.

4. Severe pulmonary disease including Chronic obstructive pulmonary disease (COPD) and asthma.