Clinical Trial Details
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NCT01051557 : Temsirolimus and Perifosine in Treating Patients With Recurrent or Progressive Malignant Glioma
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Phase I and II: Histologically confirmed intracranial malignant glioma*, including
one of the following cell types:

- Glioblastoma

- Anaplastic astrocytoma

- Anaplastic oligodendroglioma

- Anaplastic oligoastrocytoma (also called anaplastic mixed gliomas)

- Malignant glioma not otherwise specified (NOS)

- Phase I: Histologically confirmed low-grade (WHO grade II) gliomas (e.g., low-grade
astrocytoma, low-grade oligodendroglioma, low-grade oligoastrocytoma [mixed gliomas],
or low-grade glioma NOS) allowed provided there is radiographic evidence of malignant
transformation by MRI or CT scan but histologic confirmation of high-grade
(malignant) transformation would not be otherwise undertaken for routine clinical
care (phase I)

- Unstained slides or tissue blocks available from ? 1 prior surgery

- Frozen tissue requested if available

- Mandatory for phase II

- Must have received prior radiotherapy and temozolomide

- Must have unequivocal evidence of tumor progression by baseline MRI or CT scan (in
comparison to a prior scan) OR have recently undergone resection for
recurrent/progressive disease

- Must be on a stable or decreasing dose of corticosteroids for ? 5 days before
baseline MRI/CT scan (and PET scan for patients enrolled in the phase II portion
of the study)

- Stable corticosteroids are not required for patients undergoing surgery on
the surgical substudy portion of the phase II study

- Measurable disease not required for patients who recently underwent resection as long
as progressive disease led to the surgery and the histology of the most recent
surgery documented recurrent/progressive/persistent malignant glioma

- If cytoreductive surgery is planned for tumor recurrence at the time of
enrollment, such patients may be eligible for the surgical substudy (Phase II
only), taking temsirolimus and perifosine pre-operatively and then re-initiating
such therapy after recovering from the effects of surgery

- Karnofsky performance status 60-100%

- Life expectancy > 8 weeks

- WBC ? 2,000/mm^3

- ANC ? 1,500/mm^3

- Platelet count ? 100,000/mm^3

- Hemoglobin ? 10 g/dL (transfusion allowed)

- Bilirubin < 2 times upper limit of normal (ULN)

- SGOT and/or SGPT < 2 times ULN

- Calcium normal

- Phosphorus normal

- Creatinine < 1.5 mg/dL

- Cholesterol ? 350 mg/dL

- Triglycerides ? 400 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must agree to use effective contraception

- No 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 (phase II)

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to temsirolimus or perifosine

- No concurrent uncontrolled illness including, but not limited to, any of the

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness and/or social situation that would limit compliance with
study requirements

- No other concurrent anticancer therapy (including chemotherapy, radiotherapy,
hormonal therapy, or immunotherapy)

- Recovered from prior therapy

- At least 6 weeks since prior radiotherapy or nitrosoureas

- At least 4 weeks since prior temozolomide

- At least 4 weeks since prior direct inhibitors of VEGF/VEGFR (e.g., bevacizumab
[Avastin], aflibercept [VEGF Trap], cediranib [AZD2171], or XL-184 [BMS 907351])

- At least 4 weeks since prior investigational agents or cytotoxic therapy

- At least 3 weeks since prior procarbazine

- At least 2 weeks since prior vincristine

- At least 2 weeks since prior and no concurrent enzyme-inducing anti-epileptic drugs

- At least 1 week since prior non-cytotoxic agents (e.g., interferon, tamoxifen,
thalidomide, or cis-retinoic acid)

- No prior mTOR inhibitors (e.g., temsirolimus, sirolimus, or everolimus) (phase II)

- No prior perifosine or other AKT-targeting agents (phase II)

- No prior treatment with convection-enhanced delivery, other catheter-based
intra-tumoral treatment, or carmustine/Gliadel wafers (phase II)

- Prior stereotactic radiosurgery (including gamma-knife or cyber-knife) for newly
diagnosed or recurrent disease, or re-irradiation of any type allowed provided there
is confirmation of true progressive disease (rather than radiation necrosis) by
surgical documentation of recurrent/progressive disease (phase II)

- No other concurrent investigational agents

- No concurrent combination antiretroviral therapy for HIV-positive patients
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