Rituximab and ABVD for Hodgkin's Patients

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00504504
First received: July 19, 2007
Last updated: May 20, 2013
Last verified: May 2013
  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 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD [ Time Frame: Baseline to 5 Years or until disease progression ] [ Designated as safety issue: No ]
    Five year Event Free Survival (EFS) is proportion of surviving participants who remain event free out of total participants at 5 years after receiving Rituximab + ABVD (RABVD). Event-free Survival (EFS) analyzed every 6 months.


Enrollment: 85
Study Start Date: March 2001
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab + ABVD Chemotherapy
Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
Drug: Rituximab
375 mg/m^2 by vein over 3 to 8 hours weekly for 6 weeks in a row.
Other Name: Rituxan
Drug: Adriamycin
25 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
Other Names:
  • Doxorubicin
  • Rubex
Drug: Bleomycin
10 U/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
Other Names:
  • Bleomycin sulfate
  • Blenoxane
  • BLM
Drug: Vinblastine
6 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
Other Names:
  • Vinblastine Sulfate
  • Velban
Drug: Dacarbazine (DTIC)
375 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
Other Name: DTIC-Dome

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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504504

Locations
United States, Texas
UT MD . Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genentech
Investigators
Principal Investigator: Anas Younes, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
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
Results First Received: May 20, 2013
Last Updated: May 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on April 14, 2014