CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
Perifosinedrug
Likely dose
Perifosine 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00590954
NCT00590954Phase 2Completed
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Clinical and Molecular-Metabolic Phase II Trial of Perifosine for Recurrent/Progressive Malignant Gliomas

Memorial Sloan Kettering Cancer Center·interventional·Posted Jan 11, 2008·Updated Oct 19, 2020

In Brief

A Phase 2 clinical trial evaluating Perifosine for Malignant Gliomas and 3 related conditions. Completed, enrolled 32 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Gliomas, CNS, Brain Cancer, Cancer
CountriesUnited States
CollaboratorsKeryx Biopharmaceuticals, Keryx / AOI Pharmaceuticals, Inc., Online Collaborative Oncology Group, University of Wisconsin, Madison, Columbia University

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 11, 2008
Enrollment StartMay 1, 2006
Primary CompletionNov 11, 2019
TodayJul 2, 2026
Enrollment to primary: 13.5 yearsPosted 18.5 years ago

Interventions

Perifosinedrug

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.