Study of a-Interferon With Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD) With Hodgkin's Disease

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-07-31

Study Completion Date

2011-12-31

Brief Summary

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This is a clinical research study of interferon (IFN) plus chemotherapy with the standard combination of Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD). The treatment will be given to patients with Hodgkin's disease. The study will look at whether adding IFN to ABVD improves the immune response against Hodgkin's disease, and will determine whether the toxicity of ABVD is increased by adding IFN.

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Detailed Description

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Each treatment cycle will last 2 weeks. On days 1 - 4 of each cycle, patients will be given a shot of IFN under the skin. On day 4, patients will be given ABVD through a vein over one-hour.

The plan is for patients to receive 12 cycles of treatment. However, patients will leave the study if they have severe side effects or if the cancer grows or spreads. They will also leave if the cancer does not improve after 6 cycles. Patient who leave the study will be offered other treatments. A maximum of 35 patients will be treated with that dose.

Before the first treatment, patient will have a physical exam, blood tests, and a heart scan. Within 1 month of starting treatment, patients will have a chest X-ray, CT scans of the abdomen and pelvis, and a gallium scan.

During the study, patient will have blood tests every week and a physical exam every 2 weeks. The X-ray, CT scans, and gallium scan will be repeated after cycles 6 and 12.

All the drugs in this study are approved by the U.S. Food and Drug Administration and are available by prescription. ABVD is a standard treatment for Hodgkin's disease; IFN is an investigational treatment for Hodgkin's disease. About 35 patients will be enrolled in the study. All treatment will be given in the outpatient clinic at M.D. Anderson Cancer Center.

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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Interferon-2A + Chemotherapy

Interferon-2A 4 (x106 IU/m\^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m\^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)

Group Type EXPERIMENTAL

Interferon-2A

Intervention Type DRUG

4 (x106 IU/m\^2) subcutaneously on days 1-4.

Adriamycin

Intervention Type DRUG

25 mg/m\^2 by vein on day 4.

Bleomycin

Intervention Type DRUG

10 mg/m\^2 by vein on day 4.

Velban

Intervention Type DRUG

6 mg/m\^2 by vein on day 4.

Dacarbazine

Intervention Type DRUG

375 mg/m\^2 by vein on day 4.

Interventions

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Interferon-2A

4 (x106 IU/m\^2) subcutaneously on days 1-4.

Intervention Type DRUG

Adriamycin

25 mg/m\^2 by vein on day 4.

Intervention Type DRUG

Bleomycin

10 mg/m\^2 by vein on day 4.

Intervention Type DRUG

Velban

6 mg/m\^2 by vein on day 4.

Intervention Type DRUG

Dacarbazine

375 mg/m\^2 by vein on day 4.

Intervention Type DRUG

Other Intervention Names

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Interferon-Alfa-2a Roferon-A Doxorubicin Rubex Bleomycin Sulfate BLM Vinblastine DTIC-DOME

Eligibility Criteria

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Inclusion Criteria

1. Hodgkin's disease patients who relapse after radiation therapy alone, or in combination with Novantrone, Oncovin, Velban, and Prednisone (NOVP); and previously untreated patients with stage III and IV who are eligible for standard ABVD therapy.
2. Must have adequate bone marrow reserve Absolute neutrophil count (ANC) \> 1,000/uL, Platelets \> 100,000
3. Left ventricular ejection fraction (LVEF) \>/= 50%, serum creatinine \< 2mg/dl, serum bilirubin \< 2mg/dl

Exclusion Criteria

1. No prior therapy with Mustargen Oncovin Procarbazine Prednisone (MOPP).
2. No severe pulmonary disease including Chronic obstructive pulmonary disease (COPD) and asthma.

Eligible Sex

ALL

Accepts Healthy Volunteers

No