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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute Merck |
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Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00762255 |
The purpose of the this study is to see if an investigations cancer treatment called vorinostat can be combined with the irinotecan/bevacizumab regimen safely.
Condition | Intervention | Phase |
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Glioblastoma |
Drug: Vorinostat, Bevacizumab and Irinotecan Study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Trial of Vorinostat in Combination With Bevacizumab and Irinotecan in Recurrent Glioblastoma |
Estimated Enrollment: | 21 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | January 2013 |
Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Dose Escalation - Irinotecan and bevacizumab are given IV on days 1 and 15 of each cycle. Vorinostat is given orally on days 1-7 and 15-21 of each cycle.
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Drug: Vorinostat, Bevacizumab and Irinotecan Study
Determine maximum tolerated dose for treatment.
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B: Experimental
MTD - Treatment at maximum tolerated dose
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Drug: Vorinostat, Bevacizumab and Irinotecan Study
Determine maximum tolerated dose for treatment.
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Drug Administration: (A cycle is 28 days) Irinotecan and bevacizumab are given IV on days 1 and 15 of each cycle. Vorinostat is given orally on days 1-7 and 15-21 of each cycle.
Vorinostat (provided in 100mg capsules) begins at a dose of 200mg/day, escalating to 300mg/day and then to a maximum of 400mg/day. Vorinostat will be taken prior to irinotecan and bevacizumab on days 1 and 15. The drug should be administered at the same time every day for days 2-7 and 16-21. Patients will be treated prophylactically with compazine 30 minutes prior to vorinostat which, in turn, should be taken 30 minutes prior to a meal whenever possible.
Irinotecan is given at a dose of 125mg/m2. Bevacizumab is given at a dose of 10mg/kg.
MTD will be defined by toxicities occurring during the first 4 weeks of therapy. Three patients will be treated at dose level one and can be enrolled simultaneously. They must be observed for DLT for at least 4 weeks from treatment day 1. Page 15 of the protocol outlines the dose escalation parameters. At least 9 patients will be treated at the MTD. If DLT is not achieved in any cohort of up to a dose level of 400mg/day of vorinostat, further dose escalations will not be made. This dose will then become the recommended dose.
Patients demonstrating evidence of benefit may be treated up to a maximum of 24 cycles, at the investigator's discretion.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
H. Lee Moffitt Cancer Center & Research Institute, Inc. | |
Tampa, Florida, United States, 33612 |
Principal Investigator: | Prakash Chinnaiyan, M.D. | H. Lee Moffitt Cancer Center & Research Institute, Inc. |
Responsible Party: | H. Lee Moffitt Cancer Center & Research Institute, Inc. ( Prokash Chinnaiyan ) |
Study ID Numbers: | MCC-15629, Merck 33726, IRB 107179 |
Study First Received: | September 29, 2008 |
Last Updated: | August 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00762255 History of Changes |
Health Authority: | United States: Institutional Review Board |
recurrent glioblastoma multiple agents immunotherapy chemotherapy brain and nervous system |
Anticarcinogenic Agents Anti-Inflammatory Agents Glioblastoma Astrocytoma Vorinostat Irinotecan Bevacizumab Angiogenesis Inhibitors Recurrence Neuroectodermal Tumors |
Analgesics, Non-Narcotic Neoplasms, Germ Cell and Embryonal Neuroepithelioma Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Glioma Antirheumatic Agents Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
Anticarcinogenic Agents Anti-Inflammatory Agents Glioblastoma Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Irinotecan Neoplasms, Nerve Tissue Physiological Effects of Drugs Bevacizumab Sensory System Agents Neoplasms, Germ Cell and Embryonal Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Growth Inhibitors Angiogenesis Modulating Agents |
Glioma Analgesics Neoplasms by Histologic Type Astrocytoma Growth Substances Vorinostat Enzyme Inhibitors Angiogenesis Inhibitors Protective Agents Pharmacologic Actions Neuroectodermal Tumors Neoplasms Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents |