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

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01404936
First received: July 26, 2011
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: Interferon-2A
Drug: Adriamycin
Drug: Bleomycin
Drug: Velban
Drug: Dacarbazine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of a-Interferon With Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD) for Patients With Hodgkin's Disease

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Participants' Response [ Time Frame: After 6 courses (3 months) ] [ Designated as safety issue: No ]
    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.


Enrollment: 35
Study Start Date: July 1996
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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)
Drug: Interferon-2A
4 (x106 IU/m^2) subcutaneously on days 1-4.
Other Names:
  • Interferon-Alfa-2a
  • Roferon-A
Drug: Adriamycin
25 mg/m^2 by vein on day 4.
Other Names:
  • Doxorubicin
  • Rubex
Drug: Bleomycin
10 mg/m^2 by vein on day 4.
Other Names:
  • Bleomycin Sulfate
  • BLM
Drug: Velban
6 mg/m^2 by vein on day 4.
Other Name: Vinblastine
Drug: Dacarbazine
375 mg/m^2 by vein on day 4.
Other Name: DTIC-DOME

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404936

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Schering-Plough
Investigators
Principal Investigator: Anas Younes, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01404936     History of Changes
Other Study ID Numbers: DM96-060
Study First Received: July 26, 2011
Results First Received: December 21, 2012
Last Updated: January 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Interferon-alpha
Interferon Alfa-2a
Interferons
Bleomycin
Dacarbazine
Doxorubicin
Vinblastine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014