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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 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma Multiforme

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Authority:

United States: Food and Drug Administration

Study ID:

021-003

NCT ID:

NCT00394628

Start Date:

October 2006

Completion Date:

Related Keywords:

  • Glioblastoma Multiforme
  • Glioblastoma Multiforme
  • Radiotherapy
  • temozolomide
  • adjuvant temozolomide
  • Glioblastoma

Name

Location

Duke University Medical CenterDurham, North Carolina  27710
Henry Ford Health SystemsDetroit, Michigan  48202
University of California, Los AngelesLos Angeles, California  
Baylor Research InstituteDallas, Texas  75246
Northwestern University Feinberg School of MedicineChicago, Illinois  60611