Phase II Study of Combined Temozolomide and SGT-53 for Treatment of Recurrent Glioblastoma
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|ClinicalTrials.gov Identifier: NCT02340156|
Recruitment Status : Recruiting
First Posted : January 16, 2015
Last Update Posted : September 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|RECURRENT GLIOBLASTOMA||Genetic: SGT-53 Drug: Temozolomide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Combined Temozolomide and Targeted P53 Gene Therapy (SGT-53) for Treatment of Patients With Recurrent Glioblastoma|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
Experimental: SGT-53 with Temozolomide
SGT-53, at 3.6 mg DNA/infusion, will be administered twice weekly in a 28 day cycle starting on Day 1 (cycle 1), Day 29 (cycle 2) and Day 57 (cycle 3). Temozolomide (TMZ) will be administered by mouth daily on days 9-13 of each cycle. Patients who are responding to treatment may receive three additional cycles of SGT-53/TMZ therapy or continue on TMZ alone at investigator's discretion. Surgical resection of recurrent or progressive tumor for tumor analysis is an optional procedure. In these individuals SGT-53, at 3.6 mg DNA/infusion, will be administered twice (on days -1 and -3) in the week prior to surgery. Surgical resection is Day 0. 14-21 days post operatively and having recovered from the effects of surgery, the patients will then start cyclical TMZ with SGT-53 as described above.
SGT-53, at 3.6 mg DNA per infusion, will be administered twice per week for 3 weeks (on Day 1, 4, 8, 11, 15 and 18 of each cycle) for 3 cycles. If SGT-53-related toxicity occurs, the dose of SGT-53 will be de-escalated to 2.4 or 1.2 mg DNA/infusion when appropriate.Drug: Temozolomide
TMZ will be administered orally on days 9-13 of each cycle. In cycle 1, the dose of TMZ will be 150 mg/m². If the TMZ-related toxicities are tolerated in cycle 1, the dose of TMZ will be escalated to 200 mg/m² for cycle 2 and beyond. If TMZ-related toxicity occurs, the dose if TMZ will be de-escalated to 125 mg/m² (dose level -1), 100 mg/m² (dose level -2) or 75 mg/m² (dose level -3) when appropriate.
Other Name: Temodar
- Tumor response [ Time Frame: 6 months ]The 6 month progression-free survival (PFS) will be evaluated using RANO Response Criteria.
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later. ]The safety of the combination of SGT-53 and Temozolomide will be assessed by analysis of adverse experiences, clinical laboratory tests and physical examinations.
- Progression-free survival (PFS) [ Time Frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months. ]Progression-free survival is defined as the time from the date of enrollment to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurs earlier. Subjects who do not have disease progression or have not died will be censored at the date of the last tumor assessment on or prior to the clinical cutoff.
- Overall survival (OS) [ Time Frame: From date of registration until the date of death from any cause, assessed up to 180 months. ]Overall survival is defined as the time from the date of enrollment to the date of death from all causes.
- Anti-tumor Activity [ Time Frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months. ]The anti-tumor activity of the combination of SGT-53 and Temozolomide will be determined based upon the RANO criteria.
- Induction of apoptosis [ Time Frame: 3 days ]Flow cytometry or histological examination will be used to determine the level of apoptosis induced by SGT-53 in tumors resected 3 days after the first SGT-53 infusion (optional procedure)
- Nanoparticle tumor delivery [ Time Frame: 3 days ]As an indicator of nanoparticle delivery to the tumors, DNA PCR will be used to determine the presence of SGT-53 delivered exogenous wt p53 in the tumors. This analysis will be performed on any tumors resected 3 days after the first SGT-53 infusion (optional procedure)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02340156
|Contact: Kathy Hunterfirstname.lastname@example.org|
|Contact: Winnie Wuemail@example.com|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Kathy Hunter 713-745-5769 firstname.lastname@example.org|
|China Medical University Hospital||Recruiting|
|Taichung, Taiwan, 40447|
|Contact: Sophia Lin 886-937-722118 email@example.com|
|Contact: Ya-Hui Lin 886-978-523673 firstname.lastname@example.org|
|Principal Investigator: Der-Yang Cho, MD|
|Principal Investigator:||John deGroot, MD||M.D. Anderson Cancer Center|