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|NCT02340156 : Phase II Study of Combined Temozolomide and SGT-53 for Treatment of Recurrent Glioblastoma|
|Ages||Min: 18 Years Max: N/A|
- 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
- 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
- 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)
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02340156
| Link to official Clinicaltrials.gov listing