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

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ClinicalTrials.gov Identifier: NCT00389090
Recruitment Status : Terminated (AOI Pharma terminated the license agreement. IND Transferred to NCI)
First Posted : October 18, 2006
Last Update Posted : February 9, 2012
Sponsor:
Information provided by (Responsible Party):
Keryx / AOI Pharmaceuticals, Inc.

Study Description
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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
Glioma Astrocytoma Oligodendroglioma Oligoastrocytoma 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
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Study Type : Interventional  (Clinical Trial)
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 : October 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Temozolomide + O6BG Drug: Temozolomide and O6-Benzylguanine
O6BG + Temozolomide
Other Name: temodar


Outcome Measures
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Primary Outcome Measures :
  1. best objective response rate [ Time Frame: Month 1, 2 and every 2 months thereafter. ]

Secondary Outcome Measures :
  1. Safety Assessment [ Time Frame: Month 1, 2 and every 2 months thereafter ]
  2. progression-free survival [ Time Frame: every 6 months ]
  3. overall survival [ Time Frame: every 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389090


Locations
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United States, California
AOI Pharmaceuticals Investigative Site
Los Angeles, California, United States, 90033
United States, Florida
AOI Pharmaceuticals Investigative Site
Orlando, Florida, United States, 32804
United States, Illinois
AOI Pharmaceuticals Investigative Site
Chicago, Illinois, United States, 60611
AOI Pharmaceuticals Investigative Site
Evanston, Illinois, United States, 60201
United States, Kentucky
AOI Pharmaceuticals Investigative Site
Lexington, Kentucky, United States, 40536
AOI Pharmaceuticals Investigative Site
Louisville, Kentucky, United States, 40202
United States, Minnesota
AOI Pharmaceuticals Investigative Site
Minneapolis, Minnesota, United States, 54407
United States, North Carolina
AOI Pharmaceuticals Investigative Site
Durham, North Carolina, United States, 27710
United States, South Carolina
AOI Pharmaceuticals Investigative Site
Greenville, South Carolina, United States, 29605
United States, Texas
AOI Pharmaceuticals Investigative Site
Dallas, Texas, United States, 75246
AOI Pharmaceuticals Investigative Site
Houston, Texas, United States, 77024
United States, Utah
AOI Pharmaceuticals Investigative Site
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Keryx / AOI Pharmaceuticals, Inc.
Investigators
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Study Chair: Jennifer Quinn, MD Preston Robert Tisch Brain Tumor Center at Duke
More Information
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Responsible Party: Keryx / AOI Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00389090    
Other Study ID Numbers: O6BG 202
First Posted: October 18, 2006    Key Record Dates
Last Update Posted: February 9, 2012
Last Verified: February 2012
Keywords provided by Keryx / AOI Pharmaceuticals, Inc.:
temozolomide resistant
anaplastic glioma
anaplastic astrocytoma
anaplastic oligodendroglioma
anaplastic oligoastrocytoma
Additional relevant MeSH terms:
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Glioma
Astrocytoma
Oligodendroglioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
 Neoplasms, Nerve Tissue
Temozolomide
O(6)-benzylguanine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors