Skip to main content
OpenTrials
Completed

NCT Number: NCT01404936

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interferon-2A

Drug

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

Other names: Interferon-Alfa-2a, Roferon-A

Adriamycin

Drug

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

Other names: Doxorubicin, Rubex

Bleomycin

Drug

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

Other names: Bleomycin Sulfate, BLM

Velban

Drug

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

Other names: Vinblastine

Dacarbazine

Drug

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

Other names: DTIC-DOME

Primary outcomes

  1. Participants' Response

    Time frame: After 6 courses (3 months)

    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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • Schering-Plough

Registry information

Official study title

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

Important dates

Study start
1996
Primary completion
2011
Study completion
2011
First posted
Jul 28, 2011
Registry last updated
Feb 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.