Intervention: Temozolomide
Trial phase: Phase 2
ATC code: L01AX03
SMILES: Cn1nnc2c(C(N)=O)ncn2c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: SGT-53, at 3.6 mg DNA/infusion, was 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) was administered by mouth daily on days 9-13 of each cycle.
Eligibility criteria:
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 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
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 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.
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)