Brief Summary

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

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Oct 2006

Geographic Reach

1 country

12 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.3 years study duration

Study Start

First participant enrolled

October 1, 2006

Completed

15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2006

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed

8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed

Last Updated

February 9, 2012

Status Verified

February 1, 2012

Enrollment Period

1.7 years

First QC Date

October 16, 2006

Last Update Submit

February 7, 2012

Conditions

Glioma Astrocytoma Oligodendroglioma Oligoastrocytoma

Keywords

temozolomide resistantanaplastic gliomaanaplastic astrocytomaanaplastic oligodendrogliomaanaplastic oligoastrocytoma

Outcome Measures

Primary Outcomes (1)

best objective response rate
Month 1, 2 and every 2 months thereafter.

Secondary Outcomes (3)

Safety Assessment
Month 1, 2 and every 2 months thereafter
progression-free survival
every 6 months
overall survival
every 6 months

Study Arms (1)

Temozolomide + O6BG

EXPERIMENTAL

Drug: Temozolomide and O6-Benzylguanine

Interventions

Temozolomide and O6-BenzylguanineDRUG

O6BG + Temozolomide

Also known as: temodar

Temozolomide + O6BG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients with histologically documented anaplastic glioma (anaplastic astrocytoma, anaplastic oligodendroglioma or mixed anaplastic oligoastrocytoma).
Temozolomide-resistant defined as patients who have progressed while receiving or within 8 weeks of completing the last dose of temozolomide.
Disease progression \>= 12 weeks after the completion of any radiotherapy.
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.
Bi-dimensionally measurable disease on contrast-enhanced magnetic resonance imaging study (MRI) performed within two weeks of study drug administration.
If patient received intratumoral chemotherapy or immunotherapy as part of their prior therapy then histological confirmation of recurrence is mandated.
KPS \>= 70%.
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
Signed informed consent approved by Institutional Review Board.
If sexually active, patients will take contraceptive measures for the duration of the treatment.
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.

You may not qualify if:

Pregnant or breast feeding women.
Prior treatment with O6-BG plus temozolomide in combination.
Active infection requiring intravenous antibiotics.
Known diagnosis of Human Immunodeficiency Virus (HIV) infection (HIV testing is not mandatory).
Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention.
Patients unwilling or unable to comply with the protocol.
Patients who have received stereotactic radiosurgery or brachytherapy as part of their prior therapy.
Comedication that may interfere with study results; eg. immunosuppressive agents other than corticosteroids.

Contact the study team to confirm eligibility.