Clinical Trial Details
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NCT02340156 : Phase II Study of Combined Temozolomide and SGT-53 for Treatment of Recurrent Glioblastoma
PhasePhase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- 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

- 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

- Have recovered from any previous therapy side effects or toxicities

- Organ function characterized by = Grade 1

Exclusion Criteria:

- 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

- 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

- 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.

- Serious nonmalignant disease

- Enrollment in a concomitant clinical study

- Have a history of hypersensitivity reaction to any of the components of Temozolomide

- Have a history of hypersensitivity to dacarbazine (DTIC)
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