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

Sponsor
Keryx / AOI Pharmaceuticals, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT00389090
Collaborator
(none)
32
Enrollment
12
Locations
1
Arm
28.1
Duration (Months)
2.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Temozolomide and O6-Benzylguanine
 Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Temozolomide and O6-Benzylguanine (O6-BG) in Patients With Temozolomide-Resistant Anaplastic Glioma
Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
Jun 1, 2008
Actual Study Completion Date :
Feb 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Temozolomide + O6BG

Drug: Temozolomide and O6-Benzylguanine
O6BG + Temozolomide
Other Names:
  • temodar

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Safety Assessment [Month 1, 2 and every 2 months thereafter]

    2. progression-free survival [every 6 months]

    3. overall survival [every 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. Signed informed consent approved by Institutional Review Board.

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

    3. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AOI Pharmaceuticals Investigative Site Los Angeles California United States 90033
    2 AOI Pharmaceuticals Investigative Site Orlando Florida United States 32804
    3 AOI Pharmaceuticals Investigative Site Chicago Illinois United States 60611
    4 AOI Pharmaceuticals Investigative Site Evanston Illinois United States 60201
    5 AOI Pharmaceuticals Investigative Site Lexington Kentucky United States 40536
    6 AOI Pharmaceuticals Investigative Site Louisville Kentucky United States 40202
    7 AOI Pharmaceuticals Investigative Site Minneapolis Minnesota United States 54407
    8 AOI Pharmaceuticals Investigative Site Durham North Carolina United States 27710
    9 AOI Pharmaceuticals Investigative Site Greenville South Carolina United States 29605
    10 AOI Pharmaceuticals Investigative Site Dallas Texas United States 75246
    11 AOI Pharmaceuticals Investigative Site Houston Texas United States 77024
    12 AOI Pharmaceuticals Investigative Site Salt Lake City Utah United States 84132

    Sponsors and Collaborators

    • Keryx / AOI Pharmaceuticals, Inc.

    Investigators

    • Study Chair: Jennifer Quinn, MD, Preston Robert Tisch Brain Tumor Center at Duke

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Keryx / AOI Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT00389090
    Other Study ID Numbers:
    • O6BG 202
    First Posted:
    Oct 18, 2006
    Last Update Posted:
    Feb 9, 2012
    Last Verified:
    Feb 1, 2012
    Keywords provided by Keryx / AOI Pharmaceuticals, Inc.
    temozolomide resistant
    anaplastic glioma
    anaplastic astrocytoma
    anaplastic oligodendroglioma
    anaplastic oligoastrocytoma
    Additional relevant MeSH terms:
    Glioma
    Astrocytoma
    Oligodendroglioma
    Temozolomide
    O(6)-benzylguanine

    Study Results

    No Results Posted as of Feb 9, 2012