Clinical Trials Directory

Trials / Completed

CompletedNCT01051557

Temsirolimus and Perifosine in Treating Patients With Recurrent or Progressive Malignant Glioma

Phase I/II Trial of Temsirolimus and Perifosine for Recurrent or Progressive Malignant Gliomas

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
36 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase I/II trial studies the side effects and best dose of temsirolimus when given together with perifosine and to see how well it works in treating patients with recurrent or progressive malignant glioma. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as perifosine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving temsirolimus with perifosine may be an effective treatment for malignant glioma.

Detailed description

PRIMARY OBJECTIVES: I. Define the maximum tolerated dose (MTD) of temsirolimus in combination with perifosine in patients with recurrent or progressive malignant glioma who are not taking enzyme-inducing anti-epileptic drugs (EIAEDs). (Phase I) II. Determine the efficacy of temsirolimus in combination with perifosine in patients with recurrent/progressive glioblastomas (GBMs) not taking EIAEDs as measured by 6 month progression-free survival (6mPFS) and radiographic response rates. (Phase II) SECONDARY OBJECTIVES: I. Characterize the safety profile of perifosine and temsirolimus. II. Estimate median overall and progression-free survival. III. Explore the association of pre-treatment molecular phenotype with response to treatment. IV. Explore molecular effects during treatment including phosphatidylinositol-3 kinase (PI3K)/protein kinase B (AKT)/mammalian target of rapamycin (mTOR)/ribosomal protein S6 kinase (S6K) and rat sarcoma (RAS)/mitogen-activated protein kinase kinase (MEK)/mitogen-activated protein kinase (ERK) signaling, proliferation, and apoptosis. OUTLINE: This is a phase I dose-escalation study of temsirolimus, followed by a phase II study. PHASE I: Patients receive temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22 and perifosine orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive temsirolimus and perifosine as in phase I. Some patients may also undergo cytoreductive surgery. After completion of study therapy, patients are followed up every 3 months.

Conditions

Interventions

TypeNameDescription
OTHERLaboratory Biomarker AnalysisCorrelative studies
DRUGPerifosineGiven PO
DRUGTemsirolimusGiven IV
PROCEDURETherapeutic Conventional SurgeryUndergo cytoreductive surgery

Timeline

Start date
2010-01-27
Primary completion
2018-11-16
Completion
2020-09-30
First posted
2010-01-18
Last updated
2021-07-19
Results posted
2016-04-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01051557. Inclusion in this directory is not an endorsement.