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

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ClinicalTrials.gov Identifier: NCT01404936
Recruitment Status : Completed
First Posted : July 28, 2011
Results First Posted : February 1, 2013
Last Update Posted : February 1, 2013
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: Interferon-2A Drug: Adriamycin Drug: Bleomycin Drug: Velban Drug: Dacarbazine Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 1996
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hodgkin Disease

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404936


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

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01404936    
Other Study ID Numbers: DM96-060
First Posted: July 28, 2011    Key Record Dates
Results First Posted: February 1, 2013
Last Update Posted: February 1, 2013
Last Verified: January 2013
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:
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Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Interferons
Interferon-alpha
Interferon alpha-2
Doxorubicin
Liposomal doxorubicin
Bleomycin
Dacarbazine
 Vinblastine
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators