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AQ4N in Combination With Radiotherapy and Temozolomide in Subjects With Newly Diagnosed Glioblastoma Multiforme

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00394628
Recruitment Status : Unknown
Verified May 2007 by Novacea.
Recruitment status was:  Recruiting
First Posted : November 1, 2006
Last Update Posted : May 30, 2007
Sponsor:
Information provided by:
Novacea

Study Description
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Brief Summary:

Phase 1b of the study, will evaluate the safety and tolerability of AQ4N treatment at three different dose levels.

Phase 2a of the study, will further evaluate the safety, tolerability, and in addition efficacy of AQ4N treatment at a tolerated dose selected from Phase 1b.


Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Drug: AQ4N Drug: Temozolomide Procedure: Radiotherapy Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2a, Multicenter, Open-Label Study of AQ4N in Combination With Radiation Therapy and Temozolomide, to Evaluate the Safety, Tolerability, and Efficacy in Subjects With Newly Diagnosed Glioblastoma Multiforme
Study Start Date : October 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Phase 1b: Evaluation of the safety and tolerability of AQ4N in combination with radiation therapy and temozolomide (TEMODAR®)for the treatment of glioblastoma multiforme (GBM). Dose levels for the Phase 2a will be selected.
  2. Phase 2a: Rate of progression-free survival at 6 months.

Secondary Outcome Measures :
  1. Phase 2a: Rate of progression-free survival at 12 months
  2. Percent of subjects alive at 12 months
  3. Duration of progression-free survival
  4. Time to progression
  5. Duration of overall survival

Eligibility Criteria
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Information from the National Library of Medicine

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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:

  • Histologically proven intracranial Glioblastoma Multiforme (GBM) with diagnosis established by biopsy or resection within 5 weeks prior to enrollment.
  • Cranial MRI or contrast CT performed 14 days prior to study entry. Subjects without measurable or assessable disease are eligible.
  • Plan to begin partial brain radiotherapy within 24-72 hours after beginning AQ4N, and within 35 days (5 weeks) of the surgery, or if surgery cannot be performed, the biopsy that confirms GBM diagnosis. Radiation therapy must be given by external beam to a partial brian field in daily fractions of 2.0 Gy, to a planned total dose to the tumor of 60.0 Gy over 6 weeks.
  • Age equal to or greater than 18 years and life expectancy > 10 weeks.
  • Karnofsky performance status of > 60.
  • Adequate bone marrow, liver and renal functions (tests must be performed within 14 days prior to enrollment).
  • Negative serum or urine pregnancy test (females of childbearing potential only).
  • Willingness to use effective contraception (both males and females of child-bearing potential) throughout the study and for at least 2 months after study treatment.
  • Able and willing to give informed consent.

Exclusion Criteria:

  • Previous radiotherapy to the brain.
  • Previous cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy directed against the brain tumor. Subjects who received Gliadel wafers will be excluded.
  • Subjects previously treated with enzyme-induced antiepileptic drugs (EIAEDs) must have discontinued treatment with these agent(s) greater than or equal to 2 weeks prior to enrollment.
  • A history of any other primary malignancy that has not been treated with curative intent and that has not been in complete remission for at least 2 years (exempt from the two year limit are non-melanoma skin cancer and cervical carcinoma in-situ on biopsy or a squamous intraepithelial lesion on PAP smear).
  • Active infection.
  • Any significant medical illnesses or toxicities that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the subjects' ability to tolerate this therapy. Subjects must not have any disease that will obscure toxicity or dangerously alter drug metabolism, e.g. congestive heart failure, moderate to severe liver and renal disease, other cancers.
  • Cardiac ejection fraction (LVEF) by multiple gated acquisition scan (MUGA) less than the institutional lower limit of normal.
  • Prior investigational therapy within the past 28 days.
  • Prior AQ4N therapy.
  • Hypersensitivity to AQ4N or to any ingredients contained in the drug formulation.
  • Hypersensitivity to temozolomide or to any ingredients contained in the drug formulation and dacarbazine (DTIC).
  • Pregnant or lactating women.
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): NCT00394628


Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States
Contact: Emese Filka    310-794-3521      
Principal Investigator: Tim Clughsey, MD         
United States, Illinois
Northwestern University Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Lilia Gallot    312-695-1363      
Principal Investigator: Jeffrey Raizer, MD         
United States, Michigan
Henry Ford Health Systems Recruiting
Detroit, Michigan, United States, 48202
Contact: Ruth Ann Beasse    313-916-3731    rbeasse1@hfhs.org   
Principal Investigator: Tom Mikkelsen, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Velmeca McCrea    919-684-5632    velmeca.mccrea@duke.edu   
Principal Investigator: David Reardon, MD         
United States, Texas
Baylor Research Institute Recruiting
Dallas, Texas, United States
Contact: Stephanie Peschka, RN    214-820-8685      
Principal Investigator: Karen Fink, MD         
Sponsors and Collaborators
Novacea
More Information
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ClinicalTrials.gov Identifier: NCT00394628    
Other Study ID Numbers: 021-003
First Posted: November 1, 2006    Key Record Dates
Last Update Posted: May 30, 2007
Last Verified: May 2007
Keywords provided by Novacea:
Glioblastoma Multiforme
Radiotherapy
temozolomide
adjuvant temozolomide
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents