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Rituximab and ABVD for Hodgkin's Patients

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma

Intervention: Rituximab (Drug); Adriamycin (Drug); Bleomycin (Drug); Vinblastine (Drug); Dacarbazine (DTIC) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Anas Younes, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

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.

Clinical Details

Official title: A Phase II Study of Rituximab + ABVD for Patients With Hodgkin's Disease

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD

Detailed description: Before treatment starts, patients will have a physical exam. Bone marrow samples will be taken. Blood samples (4 to 8 tablespoons) will be taken before and during the study. A chest x-ray, CT scans of the abdomen and pelvis, and a gallium scan will be done if necessary. Patients in this study will receive rituximab by vein over 3 to 8 hours weekly for 6 weeks in a row. ABVD will be injected over 3 hours every other week for a total of 12 treatments. On the cycles where both rituximab and ABVD are given, rituximab will be given on day 1, and ABVD will be given on day 2. Response to therapy will be determined after 3 months and at the end of therapy (6 months). At the end, patients may receive radiation therapy to areas of large masses. All treatments can be given in an outpatient setting. Scans and x-rays will be repeated if needed after completion of therapy and every 3 months from then on. If tumors do not shrink after 3 months of therapy, patients will be offered a different treatment. This is an investigational study. Although ABVD is considered the standard treatment for patients with Hodgkin's disease, the combination of ABVD with rituximab is considered investigational. All drugs involved in this study are commercially available and are approved by the FDA. Up to 85 patients will take part in this study. All will be enrolled at M. D. Anderson. This protocol is partially funded by a research grant from Genentech.

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

UT MD . Anderson Cancer Center, Houston, Texas 77030, United States
Additional Information

UT MD Anderson Cancer Center website

Starting date: March 2001
Last updated: May 20, 2013

Page last updated: August 23, 2015

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