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

Study Overview
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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.

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.

Official Title
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A Phase II Study of a-Interferon With Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD) for Patients With Hodgkin's Disease

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: Interferon-2A
* Drug: Adriamycin
* Drug: Bleomycin
* Drug: Velban
* Drug: Dacarbazine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Must have adequate bone marrow reserve Absolute neutrophil count (ANC) > 1,000/uL, Platelets > 100,000 Left ventricular ejection fraction (LVEF) >/= 50%, serum creatinine < 2mg/dl, serum bilirubin < 2mg/dl Exclusion Criteria: No prior therapy with Mustargen Oncovin Procarbazine Prednisone (MOPP). No severe pulmonary disease including Chronic obstructive pulmonary disease (COPD) and asthma.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interferon-2A + Chemotherapy<br>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) | Drug: Interferon-2A<br>* 4 (x106 IU/m^2) subcutaneously on days 1-4.<br>* Other names: Roferon-A;Drug: Adriamycin<br>* 25 mg/m^2 by vein on day 4.<br>* Other names: Rubex;Drug: Bleomycin<br>* 10 mg/m^2 by vein on day 4.<br>* Other names: BLM;Drug: Velban<br>* 6 mg/m^2 by vein on day 4.<br>* Other names: Vinblastine;Drug: Dacarbazine<br>* 375 mg/m^2 by vein on day 4.<br>* Other names: DTIC-DOME;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants' Response | Complete Response (CR): Disappearance of all clinical evidence of active tumors for a minimum of 8 weeks. Partial Response (PR): 50% or greater decrease in sum of products all measured lesions persisting for at least 4 weeks. No Change: Steady state or change of +/- 25% of tumor size and no progression for minimum of 8 weeks with no appearance of new lesions. Progressive Disease: > 25 % increase in size of any measurable lesion or appearance of significant new lesions. | After 6 courses (3 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphoma, Hodgkin's Disease, Stage III and IV, Adriamycin, Doxorubicin, Rubex, Bleomycin, Bleomycin Sulfate, BLM, Dacarbazine, DTIC-DOME, Interferon-2A, Interferon-Alfa-2a, Roferon-A, Velban, Vinblastine