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

NCT01404936 | Completed Phase 2 Results

• 1 other identifier: DM96-060
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Interferon-2A + Chemotherapy

EXPERIMENTAL

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; Drug: Adriamycin; Drug: Bleomycin; Drug: Velban; Drug: Dacarbazine

Interventions

Interferon-2A DRUG

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

Also known as: Interferon-Alfa-2a, Roferon-A

Interferon-2A + Chemotherapy

Adriamycin DRUG

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

Also known as: Doxorubicin, Rubex

Interferon-2A + Chemotherapy

Bleomycin DRUG

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

Also known as: Bleomycin Sulfate, BLM

Interferon-2A + Chemotherapy

Velban DRUG

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

Also known as: Vinblastine

Interferon-2A + Chemotherapy

Dacarbazine DRUG

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

Also known as: DTIC-DOME

Interferon-2A + Chemotherapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Schering-Plough: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Website

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Interferon alpha-2; Doxorubicin; Bleomycin; Vinblastine; Dacarbazine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Glycopeptides; Glycoconjugates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Anas Younes, MD / Professor
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Anas Younes, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: July 28, 2011
• Study Start: July 1, 1996
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 1, 2013
• Results First Posted: February 1, 2013

Record last verified: 2013-01

Locations

US (1)