Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02238496 : Perifosine and Torisel (Temsirolimus) for Recurrent/Progressive Malignant Gliomas
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Histologically confirmed intracranial glioblastoma (GBM), including sub variants

- At least 15 unstained slides or at least 1 tissue blocks must be collected from at
least one prior surgery.

- Received prior radiotherapy and prior temozolomide as treatment for the malignant
glioma

- Recovered from toxic effects of prior therapies and at least 2 weeks must have
elapsed since any prior signaling pathway modulators; in general, at least 4 weeks
must have elapsed from any other anticancer therapy

- Able to undergo contrast enhanced magnetic resonance imaging (MRI) scans or CT scans

- Shown unequivocal evidence for contrast enhancing tumor progression by MRI or CT in
comparison to a prior scan

- Age > or = 18 years

- Karnofsky Performance Status > or = 70

- Life expectancy of > 8 weeks

- Normal organ and marrow function, adequate liver function, and adequate renal
function before starting therapy

- Platelet count of at least 100,000/mm3 on at least 2 consecutive blood draws at least
1 week apart with results stable or trending upward

- Normal coagulation

- Cholesterol level < or = 350 mg/dl and triglycerides level < or = 400 mg/dl

- Women of child-bearing potential and men must agree to use adequate contraception
prior to study entry and for the duration of study participation

- Women of childbearing potential must have a negative beta-human chorionic
gonadotropin (B-hCG) pregnancy test documented within 7 days prior to treatment

- Women must agree not to breast feed

- Ability to understand and the willingness to sign a written informed consent document

- Ability to swallow tablets

Group A (medical) specific inclusion criteria:

- Fulfill all of the general inclusion criteria

- At least 3 months between any prior brain radiotherapy and initiation of study
therapy

- MRI/CT must demonstrate measurable enhancing tumor of at least 1cm squared in
cross-sectional area to allow assessment of radiographic response

- On stable or decreasing dose of corticosteroids for a minimum of 5 days before the
baseline MRI/CT

- The baseline brain MRI/CT must be performed less than 15 days prior to initiation of
study treatment. Otherwise it must be repeated

Group B (surgical) specific inclusion criteria:

- Fulfill all of the general inclusion criteria

- Have cytoreductive surgery as part of their routine care for recurrent tumor

- Have cytoreductive surgery as part of their routine care for recurrent tumor

- A brain MRI/CT must be performed less than 15 days prior to initiation of study
treatment. Otherwise it must be repeated

Exclusion Criteria:

- There is no limit on the number or type of prior chemotherapies except:

1. convection enhanced delivery, catheter based intra-tumoral treatment, or
carmustine (BCNU)/Gliadel® wafers

2. stereotactic radiosurgery, or re-irradiation of any type

3. agent designed to inhibit mTOR or PI3K/AKT

4. direct Vascular Endothelial Growth Factor (VEGF)/Vascular Endothelial Growth
Factor Receptors (VEGFR) inhibitors

- Smoking or plan to smoke tobacco or marijuana during study therapy

- Plan to eat grapefruit or drink grapefruit juice during study therapy

- Receiving any other investigational agents concurrently with study treatment

- Taking hepatic Enzyme Inducing Anti-Epileptic Drug (EIAED)

- Taking medications that are inducers or inhibitors of Cytochrome P450 3A4 (CYP3A4)
for at least two weeks prior to study treatment

- Uncontrolled intercurrent illness

- HIV-positive patients on combination antiretroviral therapy

- Other active concurrent malignancy

- History of gout which can be exacerbated by perifosine

- Known history of allergic reactions attributed to compounds of similar chemical or
biologic composition to temsirolimus or perifosine

- Therapeutic anticoagulation

- History of hemorrhagic or ischemic stroke

- Prior intratumoral bleeding must be evaluated with a non-contrast head CT to exclude
acute blood prior to start of treatment
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02238496      |      Link to official Clinicaltrials.gov listing
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