Status:
COMPLETED
Study of the Poly (ADP-ribose) Polymerase-1 (PARP-1) Inhibitor BSI-201 in Patients With Newly Diagnosed Malignant Glioma
Lead Sponsor:
Sanofi
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The phase I portion of study is designed to determine the Maximum Tolerated Dose (MTD) of BSI-201 with two clinically relevant dosing regimens of temozolomide (TMZ). Secondary objectives in the phase ...
Eligibility Criteria
Inclusion
- Patients must be at least 18 years of age
- Patients must have a Karnofsky performance status \> 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
- Patients must have the following hematologic, renal and liver function (i.e. Absolute neutrophil count \> 1500/mm3, Platelets \> 100,000/mm3, creatinine \< 1.7 mg/dl, total bilirubin ≤ 1.5 mg/dl, transaminases \< 4 times above the upper limits of the institutional normal
- Patients must be able to provide written informed consent
- Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Women of childbearing potential must have a negative pregnancy test. The anti-proliferative activity of this experimental drug as well as the standard drug (temozolomide) may be harmful to the developing fetus or nursing infant
- Patients must have a Mini Mental Status Exam score of \> 15
- Patients must have tumor tissue form completed and signed by a pathologist. See section 9.6 for details
- Phase I Criteria (Phase I Patients ONLY)
- Patients must have histologically proven supratentorial malignant glioma (anaplastic astrocytoma, anaplastic oligodendroglioma or glioblastoma multiforme)
- Patients must have received at least 80% of planned temozolomide and radiation therapy with no grade 3 or grade 4 toxicity attributed to the temozolomide
- Patients must have received planned treatment with radiation therapy and concomitant temozolomide at least 28 days but no more than 49 days prior to starting treatment on this study
- Patients must have Gadolinium MRI or contrast CT scan within 28 days of starting treatment
Exclusion
- Patients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety
- Patients who are pregnant or breast-feeding. The anti-proliferative activity of this experimental drug and temozolomide may be harmful to the developing fetus or nursing infant
- Patients receiving concurrent therapy for their tumor (i.e. chemotherapeutics or investigational agents)
- Patients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin. Patients who have been free of disease (any prior malignancy) for greater than five years are eligible for this study
- Patients cannot be receiving cytochrome P450-inducing anticonvulsants (EIAEDs; e.g., phenytoin, carbamazepine, phenobarbital, primidone, oxcarbazepine) and must not have taken them for at least 10 days
- Phase I Ineligibility Criteria (Phase I Patients ONLY)
- Patients who have had repeat craniotomy for tumor therapy after receiving RT and TMZ treatment
- Patients who received other chemotherapeutics or investigational agents in addition to their radiation therapy and concomitant temozolomide treatment. Patients who have received Gliadel wafers are eligible for this study
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00687765
Start Date
July 1 2008
End Date
June 1 2015
Last Update
September 14 2022
Active Locations (8)
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1
Research Site
Birmingham, Alabama, United States, 35294
2
Research Site
Tampa, Florida, United States, 33612
3
Research Site
Atlanta, Georgia, United States, 30322
4
Research Site
Baltimore, Maryland, United States