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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00389090
Other study ID # O6BG 202
Secondary ID
Status Terminated
Phase Phase 2
First received October 16, 2006
Last updated February 7, 2012
Start date October 2006
Est. completion date February 2009

Study information

Verified date February 2012
Source Keryx / AOI Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 32
Est. completion date February 2009
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Temozolomide and O6-Benzylguanine
O6BG + Temozolomide

Locations

Country Name City State
United States AOI Pharmaceuticals Investigative Site Chicago Illinois
United States AOI Pharmaceuticals Investigative Site Dallas Texas
United States AOI Pharmaceuticals Investigative Site Durham North Carolina
United States AOI Pharmaceuticals Investigative Site Evanston Illinois
United States AOI Pharmaceuticals Investigative Site Greenville South Carolina
United States AOI Pharmaceuticals Investigative Site Houston Texas
United States AOI Pharmaceuticals Investigative Site Lexington Kentucky
United States AOI Pharmaceuticals Investigative Site Los Angeles California
United States AOI Pharmaceuticals Investigative Site Louisville Kentucky
United States AOI Pharmaceuticals Investigative Site Minneapolis Minnesota
United States AOI Pharmaceuticals Investigative Site Orlando Florida
United States AOI Pharmaceuticals Investigative Site Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
Keryx / AOI Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary best objective response rate Month 1, 2 and every 2 months thereafter. No
Secondary Safety Assessment Month 1, 2 and every 2 months thereafter Yes
Secondary progression-free survival every 6 months No
Secondary overall survival every 6 months No
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