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

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)