Clinical and Molecular-Metabolic Phase II Trial of Perifosine for Recurrent/Progressive Malignant Gliomas

NCT00590954 | Completed Phase 2 Results

• 1 other identifier: 06-044
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Gliomas; CNS; Brain Cancer; Cancer

Keywords

Malignant Gliomas; CNS; Brain Cancer; Cancer; Perifosine

Outcome Measures

Primary Outcomes (1)

• Determine the Efficacy of Perifosine in Patients With Recurrent/Progressive GBMs Not Taking EIAEDs as Measured by 6 Month Progression Free Survival/PFS.

  6 months

Secondary Outcomes (1)

• Determine Metabolic Effects of Perifosine on Malignant Gliomas by PET Imaging

  2 years

Study Arms (1)

Treatment

EXPERIMENTAL

Following a diagnosis of tumor recurrence or progression, all patients will receive perifosine monotherapy until toxicity, progression, or death.

Drug: Perifosine

Interventions

Perifosine DRUG

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.

Also known as: NSC 639966, D21266, KRX-0401

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have shown unequivocal evidence for tumor progression by MRI or CT scan.
• Patients must be on a stable or decreasing dose of corticosteroids for a minimum of 5 days before the baseline MRI and PET scans.
• Patients must have failed prior radiation therapy.
• Patients with prior therapy that included interstitial brachytherapy or stereotactic radiosurgery (including gamma-knife or cyber-knife) must have confirmation of true progressive disease rather than radiation necrosis based upon either PET or Thallium scanning, and/or MR spectroscopy, and/or MR Perfusion, and/or surgical documentation of disease.
• All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must have signed an authorization for the release of their protected health information.
• Age \> 18 years old, and with a life expectancy \> 8 weeks.
• Karnofsky Performance Status ≥ 50%
• Patients must have recovered from all acute toxicities from prior therapies. At least 28 days must have elapsed since prior radiation.
• Patients must have adequate bone marrow function
• Patients must agree to practice adequate contraception.

You may not qualify if:

• Patients must not be taking EIAEDs
• Patients must not have any significant medical illnesses or other history that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy.
• Patients with a 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 are ineligible.
• Patients must not have active infection or serious intercurrent medical illness.
• HIV-Positive patients receiving combination anti-retroviral therapy are excluded from the study due to possible retro-viral drug interactions.
• Patients must not have any disease that will obscure toxicity or dangerously alter drug metabolism.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Keryx Biopharmaceuticals: collaborator
• Keryx / AOI Pharmaceuticals, Inc.: collaborator
• Online Collaborative Oncology Group: collaborator
• University of Wisconsin, Madison: collaborator
• Columbia University: collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering web site

MeSH Terms

Conditions

Glioma; Brain Neoplasms; Neoplasms

Interventions

perifosine; octadecyl-(N,N-dimethylpiperidino-4-yl)-phosphate

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Thomas Kaley, MD
• Organization: Memorial Sloan Kettering Cancer Center

kaleyt@mskcc.org

212-639-5122

Study Officials

• Thomas Kaley, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 11, 2008
• Study Start: May 1, 2006
• Primary Completion: November 11, 2019
• Study Completion: November 11, 2019
• Last Updated: October 19, 2020
• Results First Posted: October 19, 2020

Record last verified: 2019-11

Locations

US (1)