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Perifosine and Torisel (Temsirolimus) for Recurrent/Progressive Malignant Gliomas

NCT02238496 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-05-25

No results posted yet for this study

Summary

The purpose of this study is to test the effectiveness of a drug called temsirolimus in combination with a drug called perifosine in treating brain tumors that have continued to grow after previous treatment. Temsirolimus is an intravenous drug approved by the FDA for treatment of other cancers (kidney cancer, certain types of lymphoma) but not for brain tumors. Perifosine is a pill that has not been approved by the FDA which blocks a messenger that tells cancer cells to grow. Research suggests that combined treatment with both drugs is better than either alone, and that it is reasonably safe.

Conditions

  • Brain Tumor, Recurrent
  • Glioblastoma
  • Anaplastic Astrocytoma
  • Anaplastic Oligodendroglioma
  • Mixed Glioma

Interventions

PROCEDURE

Cytoreductive surgery

Standard of care/routine cytoreductive glioma resection surgery. Arm B only.

DRUG

Perifosine

Perifosine is a pill that has not been approved by the FDA which blocks a messenger that tells cancer cells to grow.

DRUG

Temsirolimus

Temsirolimus is an intravenous drug approved by the FDA for treatment of other cancers (kidney cancer, certain types of lymphoma) but not for brain tumors.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • AEterna Zentaris

    collaborator INDUSTRY

  • Andrew B Lassman, MD

    lead OTHER

Principal Investigators

  • Andrew B. Lassman, MD · Columbia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-08
Primary Completion
2017-10-27
Completion
2021-02-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02238496 on ClinicalTrials.gov