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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Schering-Plough |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01404936 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: Interferon-2A Drug: Adriamycin Drug: Bleomycin Drug: Velban Drug: Dacarbazine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
| Enrollment: | 35 |
| Study Start Date: | July 1996 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
Drug: Adriamycin
25 mg/m^2 by vein on day 4.
Other Names:
Drug: Bleomycin
10 mg/m^2 by vein on day 4.
Other Names:
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
|
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Anas Younes, MD | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01404936 History of Changes |
| Other Study ID Numbers: | DM96-060 |
| Study First Received: | July 26, 2011 |
| Last Updated: | December 12, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
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 Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Interferon-alpha Interferon Alfa-2a Interferons Bleomycin Dacarbazine Doxorubicin Vinblastine |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Antibiotics, Antineoplastic Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |