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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Merck |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00787527 |
Purpose
The goal of this clinical research study is to find out how well the drug Zolinza (vorinostat) works in combination with the drug combination called CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) to treat patients with untreated T-cell NHL. The safety of these drugs in combination and the best dose of vorinostat when given in combination with CHOP will also be studied.
Objectives:
Primary Objectives:
Phase I:
Determine the toxicity profile and the maximum tolerated dose (MTD) of vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP)
Phase II:
Secondary Objectives (Phase I and II):
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: Zolinza (vorinostat) Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone |
Phase I Phase II |
| 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 I/II of Vorinostat Plus CHOP in Untreated T-cell Non-Hodgkin's Lymphoma |
| Estimated Enrollment: | 52 |
| Study Start Date: | November 2008 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Zolinza + CHOP
Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)
|
Drug: Zolinza (vorinostat)
Starting dose of 100 mg capsules by mouth twice daily on Days 5-14 of 21 day cycle
Other Names:
Drug: Cyclophosphamide
750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle
Other Names:
Drug: Doxorubicin
50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle
Other Names:
Drug: Vincristine
1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle
Drug: Prednisone
100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Anas Younes, MD | 713-792-2860 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Anas Younes, MD 713-792-2860 | |
| Principal Investigator: Anas Younes, MD | |
| Principal Investigator: | Anas Younes, MD | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00787527 History of Changes |
| Other Study ID Numbers: | 2008-0484 |
| Study First Received: | November 6, 2008 |
| Last Updated: | December 14, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Lymphoma Non-Hodgkin's Lymphoma SAHA Vorinostat Suberoylanilide Hydroxamic Acid MSK-390 CHOP Cyclophosphamide Doxorubicin AD Hydroxydaunomycin hydrochloride Cytoxan |
Neosar Vincristine Prednisone Untreated T-cell T-cell NHL Peripheral T-cell lymphoma PTCL CD 30 Anaplastic large cell lymphoma Angioimmunoblastic T-cell lymphoma Intestinal T-cell lymphoma Subcutaneous panniculitic T-cell lymphoma |
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Vorinostat Doxorubicin Prednisone Vincristine Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal |