Rituximab and ABVD for Hodgkin's Patients

M.D. Anderson Cancer Center

Status and phase: Completed; Phase 2

Conditions: Lymphoma

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00504504

ID00-218

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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85 participants in 1 patient group

Rituximab + ABVD Chemotherapy

Experimental group

Description:

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.

Treatment:

Drug: Dacarbazine (DTIC)

Drug: Rituximab

Drug: Adriamycin

Drug: Vinblastine

Drug: Bleomycin