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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Novacea.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Novacea
ClinicalTrials.gov Identifier:
NCT00394628
First received: October 31, 2006
Last updated: May 29, 2007
Last verified: May 2007
  Purpose

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 Intervention Phase
Glioblastoma Multiforme
Drug: AQ4N
Drug: Temozolomide
Procedure: Radiotherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novacea:

Primary Outcome Measures:
  • 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.
  • Phase 2a: Rate of progression-free survival at 6 months.

Secondary Outcome Measures:
  • Phase 2a: Rate of progression-free survival at 12 months
  • Percent of subjects alive at 12 months
  • Duration of progression-free survival
  • Time to progression
  • Duration of overall survival

Estimated Enrollment: 60
Study Start Date: October 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394628

Locations
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

No publications provided

ClinicalTrials.gov Identifier: NCT00394628     History of Changes
Other Study ID Numbers: 021-003
Study First Received: October 31, 2006
Last Updated: May 29, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Novacea:
Glioblastoma Multiforme
Radiotherapy
temozolomide
adjuvant temozolomide

Additional relevant MeSH terms:
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
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014