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


Phase 2
N/A
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Participants' Response

Outcome Description:

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.

Outcome Time Frame:

After 6 courses (3 months)

Safety Issue:

No

Principal Investigator

Anas Younes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

DM96-060

NCT ID:

NCT01404936

Start Date:

July 1996

Completion Date:

December 2011

Related Keywords:

  • Lymphoma
  • 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
  • Hodgkin Disease
  • Lymphoma

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030