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Phase I/II Study of the Poly (ADP-ribose) Polymerase-1 (PARP-1) Inhibitor BSI-201 in Patients With Newly Diagnosed Malignant Glioma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma

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Trial Information

Phase I/II Study of the Poly (ADP-ribose) Polymerase-1 (PARP-1) Inhibitor BSI-201 in Patients With Newly Diagnosed Malignant Glioma


Inclusion Criteria:



1. Patients must be at least 18 years of age

2. 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)

3. 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

4. Patients must be able to provide written informed consent

5. 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

6. Patients must have a Mini Mental Status Exam score of > 15

7. 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)

1. Patients must have histologically proven supratentorial malignant glioma (anaplastic
astrocytoma, anaplastic oligodendroglioma or glioblastoma multiforme)

2. 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

3. 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

4. Patients must have Gadolinium MRI or contrast CT scan within 28 days of starting
treatment

Exclusion Criteria:

1. 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

2. 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

3. Patients receiving concurrent therapy for their tumor (i.e. chemotherapeutics or
investigational agents)

4. 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

5. 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)

1. Patients who have had repeat craniotomy for tumor therapy after receiving RT and TMZ
treatment

2. 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the Maximum Tolerated Dose (MTD) of BSI-201, administered as an IV infusion in patients with newly diagnosed malignant glioma when given with temozolomide (TMZ) after the completion of standard radiation therapy and concomitant TMZ

Outcome Time Frame:

10 weeks

Safety Issue:

Yes

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

TCD11616

NCT ID:

NCT00687765

Start Date:

May 2008

Completion Date:

December 2012

Related Keywords:

  • Glioblastoma
  • patients with newly diagnosed glioblastoma
  • Glioblastoma
  • Glioma

Name

Location

Research SiteAlabaster, Alabama  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteBaltimore, Maryland  
Research SiteBeverly, Massachusetts  
Research SiteBattle Kreek, Michigan  
Research SiteAsheville, North Carolina  
Research SiteAllentown, Pennsylvania