Phase II Study of Combined Temozolomide and SGT-53 for Treatment of Recurrent Glioblastoma

Stopped early · Phase 2

Conditions studied: RECURRENT GLIOBLASTOMA

In brief

This Phase II clinical trial is an open label, single arm, multicenter study of the combination of intravenously administered SGT-53 and oral temozolomide in patients with confirmed glioblastoma who have proven tumor recurrence or progression. The objective of this trial is to assess 6 month progression free survival (PFS), overall survival (OS), anti-tumor activity, safety and possibly to evaluate, nanoparticle delivery to tumor site, and the induction of apoptosis in the tumor..

Key facts

Study ID

NCT02340156

Run by

SynerGene Therapeutics, Inc.

People needed

1

Starts

2014-12-01

Expected to finish

2018-11-01

Last updated by the study team

2021-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed glioblastoma or gliosarcoma in 1st, 2nd or 3rd relapse.
• Radiographic demonstration of disease progression following prior therapy
• Measurable disease on MRI performed within 14 days prior to registration.
• Male or female patients ≥ 18 years of age.
• Recurrent disease with an:
• interval of ≥ 3 months following radiotherapy + TMZ;
• interval of ≥ 14 days between end of surgery and start of protocol therapy for patients who have undergone surgery for recurrent disease.
• Patients who tolerated previous administration with TMZ
• Recovery from the effects of prior therapy:
• 4 weeks from cytotoxic agents
• 6 weeks from nitrosoureas
• 4 weeks from any investigational agent
• 1 week from non-cytotoxic agents
• 12 weeks from radiotherapy
• Karnofsky performance status ≥ 60%.
• Complete blood count/differential at screening with adequate bone marrow function
• If patient is receiving steroids, must be on stable or decreasing steroid dose within 5 days prior to treatment initiation with SGT-53.
• Patients must be willing to forego other cytotoxic and non-cytotoxic drug or radiation therapy against the tumor while enrolled in the study.
• Women of childbearing potential must have a negative serum beta-HCG pregnancy test documented within 3 days prior to study initiation.
• Women of childbearing potential must agree to use two reliable methods of contraception from screening and up to 30 days after discontinuation of study treatment
• Males not naturally or surgically sterile, who have a female partner of childbearing potential, must agree to use two reliable methods of contraception from screening and up to 30 days after discontinuation of study treatment
• Acceptable liver function
• Acceptable blood sugar control
• Urinalysis: No clinically significant abnormalities.
• PT and PTT ≤ 1.5 X ULN

You may not qualify if…

• Histology other than astrocytoma grade IV
• Tumor foci detected below the tentorium or beyond the cranial vault.
• Glioblastoma or gliosarcoma disease with leptomeningeal spread.
• Patients with a history of any other cancer, unless in complete remission, and off all therapy for that disease for a minimum of 5 years
• Patients with serum aspartate aminotransferase, alanine aminotransferase > 2.5 X the upper limit of normal (ULN) and bilirubin >1.5 ULN
• Moderate to severe hepatic impairment.
• Positive results from HIV serology testing, if any available.
• Supine systolic blood pressure < 100 mmHg or supine diastolic blood pressure < 50 mmHg at screening and baseline
• Renal insufficiency or serum creatinine >1.5 X ULN at screening.
• Females who are pregnant or lactating or plan to become pregnant during the course of this study.
• Substance or alcohol abuse or dependence, within 12 months prior to screening.
• Prior chemotherapy for recurrent GBM with nitrosourea compounds including Gliadel® wafers or bevacizumab.
• Prior focal radiotherapy within 3 months of screening.
• Planned treatment, or treatment with any investigational drug within 4 weeks prior to screening.
• Severe, active co-morbidity
• Patients who are currently taking Coumadin or Coumadin derivatives other than to maintain patency of venous access lines.
• Requiring renal dialysis
• Receiving hematopoietic growth factors
• Have significant baseline neuropathies
• Had prior exposure to gene vector delivery products within 6 months
• Any condition that prevents compliance with the protocol or adherence to therapy.
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
• Treated with antibiotics for infection within one week prior to study entry.
• Fever (> 38.1°C)
• Have diastolic blood pressure of > 90 mm Hg resting at baseline despite medication.

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States
• China Medical University Hospital — Taichung, Taiwan

Full record on ClinicalTrials.gov

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