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

Lymphoma Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma

• NCT number: NCT01404936
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 2
• Start date: July 1996
• Completion date: December 2011