Study of a-Interferon With Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD) With Hodgkin's Disease
|ClinicalTrials.gov Identifier: NCT01404936|
Recruitment Status : Completed
First Posted : July 28, 2011
Results First Posted : February 1, 2013
Last Update Posted : February 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: Interferon-2A Drug: Adriamycin Drug: Bleomycin Drug: Velban Drug: Dacarbazine||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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)
4 (x106 IU/m^2) subcutaneously on days 1-4.
25 mg/m^2 by vein on day 4.
10 mg/m^2 by vein on day 4.
6 mg/m^2 by vein on day 4.
Other Name: Vinblastine
375 mg/m^2 by vein on day 4.
Other Name: DTIC-DOME
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404936
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Anas Younes, MD||UT MD Anderson Cancer Center|