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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
The goal of this clinical research study is to find the highest safe dose of vorinostat (SAHA) when given with Accutane (isotretinoin) and temozolomide to patients with malignant gliomas. The safety and effectiveness of this drug combination will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma Multiforme Anaplastic Glioma |
Drug: Vorinostat Drug: Isotretinoin Procedure: Surgical Resection Drug: Temozolomide |
Phase 1 Phase 2 |
| 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 2014 (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
|
|
|
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: | March 16, 2012 |
| 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 |