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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: | NCT00555399 |
Purpose
Objectives:
Phase I
1. To determine the maximum tolerated dose (MTD) of vorinostat/isotretinoin (cRA), temozolomide (TMZ)/cRA and vorinostat/cRA/TMZ combinations in adult patients with recurrent glioblastoma multiforme (GBM) and anaplastic gliomas.
Phase II
Primary objective:
To determine the efficacy of vorinostat/cRA versus TMZ/cRA versus vorinostat/cRA/TMZ in patients with recurrent GBM as determined by Progression Free Survival (PFS) using an adaptive randomization phase II trial design.
Secondary objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma Multiforme Anaplastic Glioma |
Drug: Vorinostat Drug: Isotretinoin Procedure: Surgical Resection Drug: Temozolomide |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I / II Adaptive Randomized Trial of Vorinostat, Isotretinoin and Temozolomide in Adults With Recurrent Glioblastoma Multiforme |
| Estimated Enrollment: | 189 |
| Study Start Date: | November 2007 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ph I: Arm 1 |
Drug: Vorinostat
Phase I/Arm 1: Level 0 = 300 mg PO x 14 days; Level I = 400 mg PO x 14 days; Level II = 500 mg PO x 14 days. Phase I/Arm 3: Level -II = 300 mg PO x 14 days; Level -I = 400 mg PO x 14 days; Level 0 = 400 mg PO x 14 days; Level I = 500 mg PO x 14 days. Other Names:
Drug: Isotretinoin
Phase I/Arm 1: Level 0 = 100 mg/m^2/day PO x 21 days; Level I = 100 mg/m^2/day PO x 21 days; Level II = 100 mg/m^2/day PO x 21 days. Phase I/Arm 2: Level 0 = 100 mg/m^2/day PO x 21 days; Level I = 100 mg/m^2/day PO x 21 days; Level II = 100 mg/m^2/day PO x 21 days. Phase I/Arm 3: Level -II = 100 mg/m^2/day PO x 21 days; Level -I = 100 mg/m^2/day PO x 21 days; Level 0 = 100 mg/m^2/day PO x 21 days; Level I = 100 mg/m^2/day PO x 21 days; Level II = 100 mg/m^2/day PO x 21 days. Other Names:
|
| Experimental: Ph I: Arm 2 |
Drug: Isotretinoin
Phase I/Arm 1: Level 0 = 100 mg/m^2/day PO x 21 days; Level I = 100 mg/m^2/day PO x 21 days; Level II = 100 mg/m^2/day PO x 21 days. Phase I/Arm 2: Level 0 = 100 mg/m^2/day PO x 21 days; Level I = 100 mg/m^2/day PO x 21 days; Level II = 100 mg/m^2/day PO x 21 days. Phase I/Arm 3: Level -II = 100 mg/m^2/day PO x 21 days; Level -I = 100 mg/m^2/day PO x 21 days; Level 0 = 100 mg/m^2/day PO x 21 days; Level I = 100 mg/m^2/day PO x 21 days; Level II = 100 mg/m^2/day PO x 21 days. Other Names:
Drug: Temozolomide
Phase I/Arm 2: All Levels = 150 mg/m2/day PO X 14 days. Phase I/Arm 3: Level 0 = 150 mg/m2/day PO X 14 days; Level I = 150 mg/m2/day PO X 14 days; Level -I = 125 mg/m2/day PO X 14 days; Level -II = 125 mg/m2/day PO X 14 days; Level -III = 100 mg/m2/day PO X 14 days. Other Name: Temodar
|
| Experimental: Ph I: Arm 3 |
Drug: Vorinostat
Phase I/Arm 1: Level 0 = 300 mg PO x 14 days; Level I = 400 mg PO x 14 days; Level II = 500 mg PO x 14 days. Phase I/Arm 3: Level -II = 300 mg PO x 14 days; Level -I = 400 mg PO x 14 days; Level 0 = 400 mg PO x 14 days; Level I = 500 mg PO x 14 days. Other Names:
Drug: Isotretinoin
Phase I/Arm 1: Level 0 = 100 mg/m^2/day PO x 21 days; Level I = 100 mg/m^2/day PO x 21 days; Level II = 100 mg/m^2/day PO x 21 days. Phase I/Arm 2: Level 0 = 100 mg/m^2/day PO x 21 days; Level I = 100 mg/m^2/day PO x 21 days; Level II = 100 mg/m^2/day PO x 21 days. Phase I/Arm 3: Level -II = 100 mg/m^2/day PO x 21 days; Level -I = 100 mg/m^2/day PO x 21 days; Level 0 = 100 mg/m^2/day PO x 21 days; Level I = 100 mg/m^2/day PO x 21 days; Level II = 100 mg/m^2/day PO x 21 days. Other Names:
Drug: Temozolomide
Phase I/Arm 2: All Levels = 150 mg/m2/day PO X 14 days. Phase I/Arm 3: Level 0 = 150 mg/m2/day PO X 14 days; Level I = 150 mg/m2/day PO X 14 days; Level -I = 125 mg/m2/day PO X 14 days; Level -II = 125 mg/m2/day PO X 14 days; Level -III = 100 mg/m2/day PO X 14 days. Other Name: Temodar
|
|
No Intervention: Ph II: Arm 1
Non-Surgical
|
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|
Ph II: Arm 2
Surgical Arm
|
Procedure: Surgical Resection
Surgical Resection for recurrent Glioblastoma Multiforme
|
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: Vinay K. Puduvalli, MD | 713-792-2883 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Vinay K. Puduvalli, MD | |
| Principal Investigator: | Vinay K. Puduvalli, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00555399 History of Changes |
| Other Study ID Numbers: | 2006-0709 |
| Study First Received: | November 6, 2007 |
| Last Updated: | September 12, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Glioblastoma Multiforme Anaplastic Glioma Vorinostat Suberoylanilide Hydroxamic Acid SAHA MSK-390 Zolinza Isotretinoin |
Accutane 13-cis-Retinoic Acid Carboplatin Paraplatin CBT Temozolomide Temodar |
|
Glioblastoma Glioma Astrocytoma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Isotretinoin Tretinoin Temozolomide |
Vorinostat Dacarbazine Dermatologic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents Keratolytic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Histone Deacetylase Inhibitors Enzyme Inhibitors |