Clinical and Molecular-Metabolic Phase II Trial of Perifosine for Recurrent/Progressive Malignant Gliomas
Condition: Malignant Gliomas; CNS; Brain Cancer; Cancer
MeSH terms: Glioma; Brain Neoplasms
Intervention: Perifosine
Intervention description: Dosing will be continuous, and for the purpose of this trial a cycle will be defined as 28 days. Perifosine will be given as a 600 mg loading dose on day 1. The loading dose will be divided into 4 equal doses of 150 mg each. The first 3 doses should be given with food in the adult day hospital to allow intravenous antiemetic prophylaxis, and 4th dose at bedtime at home. The interval between doses of perifosine should be no less than 4 hours. On day 2, patients will start the maintenance dose of 100 mg daily at bedtime at home.
In addition to baseline serum, all patients will have weekly serum drawn during weeks 2-4.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Malignant Gliomas; CNS; Brain Cancer; Cancer; Perifosine

Summary:

      The purpose of this study is to test the effectiveness of perifosine in preventing further
      tumor growth using the established optimal dose of the drug. A second goal is to determine if
      perifosine can block the molecules in the tumor that drive it to divide and grow.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have shown unequivocal evidence for tumor progression by MRI or CT scan.

          -  Patients must be on a stable or decreasing dose of corticosteroids for a minimum of 5
             days before the baseline MRI and PET scans.

          -  Patients must have failed prior radiation therapy.

          -  Patients with prior therapy that included interstitial brachytherapy or stereotactic
             radiosurgery (including gamma-knife or cyber-knife) must have confirmation of true
             progressive disease rather than radiation necrosis based upon either PET or Thallium
             scanning, and/or MR spectroscopy, and/or MR Perfusion, and/or surgical documentation
             of disease.

          -  All patients must sign an informed consent indicating that they are aware of the
             investigational nature of this study. Patients must have signed an authorization for
             the release of their protected health information.

          -  Age > 18 years old, and with a life expectancy > 8 weeks.

          -  Karnofsky Performance Status ≥ 50%

          -  Patients must have recovered from all acute toxicities from prior therapies. At least
             28 days must have elapsed since prior radiation.

          -  Patients must have adequate bone marrow function

          -  Patients must agree to practice adequate contraception.

        Exclusion Criteria:

          -  Patients must not be taking EIAEDs

          -  Patients must not have any significant medical illnesses or other history that in the
             investigator's opinion cannot be adequately controlled with appropriate therapy or
             would compromise the patient's ability to tolerate this therapy.

          -  Patients with a history of any other cancer (except non-melanoma skin cancer or
             carcinoma in-situ of the cervix), unless in complete remission and off of all therapy
             for that disease for a minimum of 3 years are ineligible.

          -  Patients must not have active infection or serious intercurrent medical illness.

          -  HIV-Positive patients receiving combination anti-retroviral therapy are excluded from
             the study due to possible retro-viral drug interactions.

          -  Patients must not have any disease that will obscure toxicity or dangerously alter
             drug metabolism.