Clinical trial NCT01404936: Study of a-Interferon With Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD) With Hodgkin's Disease
Official title: A Phase II Study of a-Interferon With Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD) for Patients With Hodgkin's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Schering-Plough
First posted: 2011-07-28
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Participants' Response
timeFrame: After 6 courses (3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Anas Younes, MD
role: PRINCIPAL_INVESTIGATOR
References: