Status:
COMPLETED
Safety and Efficacy Study of TH-302 CNS Penetration in Recurrent High Grade Astrocytoma Following Bevacizumab
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Conditions:
HIGH GRADE GLIOMA
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The Primary Objectives are: * To determine the extent by which TH-302 is able to penetrate the blood brain barrier and affect tumor tissue * To assess the safety of single dose TH-302 in patients wit...
Detailed Description
Single center, dose-escalation, prospective study with TH-302 single dose at 575 mg/m2 or placebo administered preoperatively, followed by postoperative combination therapy bevacizumab at 10mg/kg ever...
Eligibility Criteria
Inclusion
- At least 18 years of age
- Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
- Histologically confirmed high grade astrocytoma
- Progression following both standard combined modality treatment with radiation and temozolomide chemotherapy, as well as anti-angiogenic therapy (ie, bevacizumab)
- Recovered from toxicities of prior therapy to grade 0 or 1
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Acceptable liver function
- Acceptable renal function
- Acceptable hematologic status
- All women of childbearing potential must have a negative serum pregnancy test and male and female subjects must agree to use effective means of contraception (surgical sterilization or the use or barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose
Exclusion
- The subject is receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin (LMWH) before the first dose of study drug.
- The subject has evidence of acute intracranial or intratumoral hemorrhage either by MRI or computerized tomography (CT) scan. Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin are eligible.
- The subject is unable to undergo MRI scan (eg, has pacemaker).
- The subject has received enzyme-inducing anti-epileptic agents within 14 days of study drug (eg, carbamazepine, phenytoin, phenobarbital, primidone).
- The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grade ≤ 1 from AEs (except alopecia, anemia and lymphopenia) due to surgery, antineoplastic agents, investigational drugs, or other medications that were administered prior to study drug.
- The subject has evidence of wound dehiscence
- Severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, symptoms due to hypoxemia or oxygen saturation \<90% by pulse oximetry after a 2 minute walk) or in the opinion of the investigator any physiological state likely to cause normal tissue hypoxia
- The subject is pregnant or breast-feeding.
- The subject has serious intercurrent illness
- The subject has inherited bleeding diathesis or coagulopathy with the risk of bleeding.
- The subject has received any of the following prior anticancer therapy:
- Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy (RIT), or intra-operative radiotherapy (IORT). Note: stereotactic radiosurgery (SRS) is allowed
- Antiangiogenic agents whose primary mode of action is through the VEGF signaling within 21 days prior to first dose of study drug (surgical subjects only)
- Non-bevacizumab systemic therapy (including investigational agents and small-molecule kinase inhibitors) or non-cytotoxic hormonal therapy (eg, tamoxifen) within 7 days or 5 half-lives, whichever is shorter, prior first dose of study drug
- Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug
- Nitrosoureas or mitomycin C within 42 days, or metronomic/protracted low-dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days, prior to first dose of study drug
- Prior treatment with carmustine wafers
- Prior treatment with TH-302
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01403610
Start Date
June 1 2011
End Date
October 1 2015
Last Update
July 24 2019
Active Locations (1)
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1
Cancer Therapy & Research Center at UTHSCSA
San Antonio, Texas, United States, 78229