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

Glioblastoma Multiforme Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00394628
• Other study ID #: 021-003
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: October 31, 2006
• Last updated: May 29, 2007
• Start date: October 2006

Study information

• Verified date: May 2007
• Source: Novacea
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Drug:
• AQ4N

• Temozolomide

Procedure:
• Radiotherapy

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Baylor Research Institute	Dallas	Texas
United States	Henry Ford Health Systems	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Novacea

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Phase 2a: Rate of progression-free survival at 6 months.
Secondary	Phase 2a: Rate of progression-free survival at 12 months
Secondary	Percent of subjects alive at 12 months
Secondary	Duration of progression-free survival
Secondary	Time to progression
Secondary	Duration of overall survival