|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Genentech |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00504504 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: Rituximab Drug: Adriamycin Drug: Bleomycin Drug: Vinblastine Drug: Dacarbazine (DTIC) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Rituximab + ABVD for Patients With Hodgkin's Disease |
| Estimated Enrollment: | 85 |
| Study Start Date: | March 2001 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Rituximab + ABVD Chemotherapy |
Drug: Rituximab
375 mg/m2 by vein over 3 to 8 hours weekly for 6 weeks in a row.
Other Name: Rituxan
Drug: Adriamycin
25 mg/m2 injected by vein over 3 hours every other week for a total of 12 treatments.
Other Names:
Drug: Bleomycin
10 U/m2 injected by vein over 3 hours every other week for a total of 12 treatments.
Other Names:
Drug: Vinblastine
6 mg/m2 injected by vein over 3 hours every other week for a total of 12 treatments.
Other Names:
Drug: Dacarbazine (DTIC)
375 mg/m2 injected by vein over 3 hours every other week for a total of 12 treatments.
Other Name: DTIC-Dome
|
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| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD . Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Anas Younes, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00504504 History of Changes |
| Other Study ID Numbers: | ID00-218 |
| Study First Received: | July 19, 2007 |
| Last Updated: | September 19, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Hodgkin's Disease Lymphoma Rituximab Rituxan Adriamycin Doxorubicin Rubex Bleomycin Bleomycin sulfate Blenoxane |
BLM Dacarbazine DTIC DTIC-Dome Vincristine Vinblastine Vinblastine Sulfate ABVD ABVD Chemotherapy Treatment |
|
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bleomycin Doxorubicin Rituximab Dacarbazine Vinblastine Antibiotics, Antineoplastic |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |