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



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:October 2006

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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

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.


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.
We found this trial at
5
sites
3310 Live Oak St
Dallas, Texas 75204
(214) 820-2687
Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
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Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Detroit, Michigan 48202
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Detroit, MI
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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