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

Primary Purpose

Malignant Gliomas, CNS, Brain Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Perifosine

About this trial

This is an interventional treatment trial for Malignant Gliomas focused on measuring Malignant Gliomas, CNS, Brain Cancer, Cancer, Perifosine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Determine Metabolic Effects of Perifosine on Malignant Gliomas by PET Imaging

Full Information

NCT ID

NCT00590954

First Posted

December 26, 2007

Last Updated

September 22, 2020

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Keryx Biopharmaceuticals, Keryx / AOI Pharmaceuticals, Inc., Online Collaborative Oncology Group, University of Wisconsin, Madison, Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT00590954

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

May 2006 (Actual)

Primary Completion Date

November 11, 2019 (Actual)

Study Completion Date

November 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Keryx Biopharmaceuticals, Keryx / AOI Pharmaceuticals, Inc., Online Collaborative Oncology Group, University of Wisconsin, Madison, Columbia University

4. Oversight

5. Study Description

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.

Detailed Description

This is a phase II study of the small molecule inhibitor perifosine (NSC 639966, D21266, KRX-0401) in the treatment of patients with recurrent glioblastoma multiforme (GBM) and other recurrent malignant gliomas. The goal of the phase II study is to determine efficacy as measured by the progressionfree survival rate after 6 months of treatment. Secondary goals include determination of molecular and metabolic effects of perifosine by tissue analysis and PET imaging. In addition, when cytoreductive surgery is recommended as part of the standard of care at study entry, patients will be considered for a "surgical arm." In this case, patients will receive perifosine for 5-10 days before surgery during which tumor will be aliquoted both for diagnostic purposes and for molecular effects of the drug in vivo and for analysis of drug penetration into tumor tissue.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Gliomas, CNS, Brain Cancer, Cancer

Keywords

Malignant Gliomas, CNS, Brain Cancer, Cancer, Perifosine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Perifosine

Other Intervention Name(s)

NSC 639966, D21266, KRX-0401

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Determine Metabolic Effects of Perifosine on Malignant Gliomas by PET Imaging

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Kaley, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan-Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mskcc.org

Description

Memorial Sloan-Kettering web site

Learn more about this trial

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

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