Rituximab and ABVD for Hodgkin's Patients

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2012-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Rituximab

Intervention Type DRUG

375 mg/m\^2 by vein over 3 to 8 hours weekly for 6 weeks in a row.

Adriamycin

Intervention Type DRUG

25 mg/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments.

Bleomycin

Intervention Type DRUG

10 U/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments.

Vinblastine

Intervention Type DRUG

6 mg/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments.

Dacarbazine (DTIC)

Intervention Type DRUG

375 mg/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments.

Interventions

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Rituximab

375 mg/m\^2 by vein over 3 to 8 hours weekly for 6 weeks in a row.

Intervention Type DRUG

Adriamycin

25 mg/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments.

Intervention Type DRUG

Bleomycin

10 U/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments.

Intervention Type DRUG

Vinblastine

6 mg/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments.

Intervention Type DRUG

Dacarbazine (DTIC)

375 mg/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments.

Intervention Type DRUG

Other Intervention Names

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Rituxan Doxorubicin Rubex Bleomycin sulfate Blenoxane BLM Vinblastine Sulfate Velban DTIC-Dome

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No