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A Phase II Study of Temozolomide and O6-Benzylguanine (O6-BG) in Patients With Temozolomide-Resistant Anaplastic Glioma


Phase 2
18 Years
N/A
Not Enrolling
Both
Glioma, Astrocytoma, Oligodendroglioma, Oligoastrocytoma

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Trial Information

A Phase II Study of Temozolomide and O6-Benzylguanine (O6-BG) in Patients With Temozolomide-Resistant Anaplastic Glioma


This open-label, multicenter, phase II trial will assess the antitumor activity and safety
of temozolomide in combination with O6-BG in patients with temozolomide-resistant anaplastic
glioma.

Forty-one to 104 evaluable patients with temozolomide-resistant anaplastic glioma will be
enrolled in this study. Total accrual on this study will not exceed 116 patients. The
patients will receive daily temozolomide on 5 consecutive days (days 1-5) along with bolus
infusions of O6-BG on days 1, 3, and 5 and a continuous infusion of O6-BG beginning
immediately after the first bolus infusion and continuing until immediately prior to the
last bolus injection. Patients will be evaluated for AEs during the course of therapy.
Patients may receive treatment at the same dose level until appearance of significant
treatment-related toxicities, disease progression or withdrawal of consent.

Tumor response will be evaluated at the end of cycle 1, cycle 2 and then every two cycles
for the duration of therapy, using physical and neurological examinations and diagnostic
imaging.


Inclusion Criteria:



1. Patients with histologically documented anaplastic glioma (anaplastic astrocytoma,
anaplastic oligodendroglioma or mixed anaplastic oligoastrocytoma).

2. Temozolomide-resistant defined as patients who have progressed while receiving or
within 8 weeks of completing the last dose of temozolomide.

3. Disease progression >= 12 weeks after the completion of any radiotherapy.

4. If patient received chemotherapy or an investigational agent as part of their prior
therapy, the patient must recover from all toxicities (<= Grade 1) prior to
enrollment on this protocol.

5. Bi-dimensionally measurable disease on contrast-enhanced magnetic resonance imaging
study (MRI) performed within two weeks of study drug administration.

6. If patient received intratumoral chemotherapy or immunotherapy as part of their prior
therapy then histological confirmation of recurrence is mandated.

7. KPS >= 70%.

8. The following laboratory results:

- Absolute neutrophil count >= 1500 cells/microliter

- Platelet count >= 100,000 cells/microliter

- SGOT <= 2.5 x ULN

- Serum creatinine <= 1.5 x ULN

9. Signed informed consent approved by Institutional Review Board.

10. If sexually active, patients will take contraceptive measures for the duration of the
treatment.

11. For patients on corticosteroids, they must have been on a stable dose 1 week prior to
baseline MRI and the dose should not be escalated over entry dose level, if
clinically possible.

Exclusion Criteria:

1. Pregnant or breast feeding women.

2. Prior treatment with O6-BG plus temozolomide in combination.

3. Active infection requiring intravenous antibiotics.

4. Known diagnosis of Human Immunodeficiency Virus (HIV) infection (HIV testing is not
mandatory).

5. Patients with a history of another primary malignancy that is currently clinically
significant or currently requires active intervention.

6. Patients unwilling or unable to comply with the protocol.

7. Patients who have received stereotactic radiosurgery or brachytherapy as part of
their prior therapy.

8. Comedication that may interfere with study results; eg. immunosuppressive agents
other than corticosteroids.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

best objective response rate

Outcome Time Frame:

Month 1, 2 and every 2 months thereafter.

Safety Issue:

No

Principal Investigator

Jennifer Quinn, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Preston Robert Tisch Brain Tumor Center at Duke

Authority:

United States: Food and Drug Administration

Study ID:

O6BG 202

NCT ID:

NCT00389090

Start Date:

October 2006

Completion Date:

February 2009

Related Keywords:

  • Glioma
  • Astrocytoma
  • Oligodendroglioma
  • Oligoastrocytoma
  • temozolomide resistant
  • anaplastic glioma
  • anaplastic astrocytoma
  • anaplastic oligodendroglioma
  • anaplastic oligoastrocytoma
  • Astrocytoma
  • Glioma
  • Oligodendroglioma

Name

Location

AOI Pharmaceuticals Investigative SiteBerkeley, California  94704
AOI Pharmaceuticals Investigative SiteChicago, Illinois  60611
AOI Pharmaceuticals Investigative SiteOrlando, Florida  32804
AOI Pharmaceuticals Investigative SiteLexington, Kentucky  40536
AOI Pharmaceuticals Investigative SiteMinneapolis, Minnesota  54407
AOI Pharmaceuticals Investigative SiteDurham, North Carolina  27710
AOI Pharmaceuticals Investigative SiteGreenville, South Carolina  29605
AOI Pharmaceuticals Investigative SiteDallas, Texas  75246
AOI Pharmaceuticals Investigative SiteSalt Lake City, Utah  84132