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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Merck |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00787527 |
Purpose
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: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
| 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 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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
Drug: Cyclophosphamide
750 mg/m^2 by vien over 1 hour on Day 1 of 21 day cycle
Drug: Doxorubicin
50 mg/m^2 by vien over 15 minutes on Day 1 of 21 day cycle
Drug: Vincristine
1.4 mg/m^2 by vien 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: Barbara Pro, MD | 713-792-2860 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Barbara Pro, MD | |
| Principal Investigator: | Barbara Pro, MD | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | UT MD Anderson Cancer Center ( Barbara Pro, MD/Associate Professor ) |
| Study ID Numbers: | 2008-0484 |
| Study First Received: | November 6, 2008 |
| Last Updated: | October 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00787527 History of Changes |
| 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 |
|
Anticarcinogenic Agents Anti-Inflammatory Agents Prednisone Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Cyclophosphamide Antibiotics, Antineoplastic Hormones Sensory System Agents Lymphoma, T-Cell Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal |
Analgesics Lymphoma Alkylating Agents Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Mitosis Modulators Vorinostat Vincristine Enzyme Inhibitors Antimitotic Agents Protective Agents Glucocorticoids Immunosuppressive Agents |