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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01051557
First received: January 15, 2010
Last updated: July 6, 2016
Last verified: June 2016
Results First Received: March 17, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adult Anaplastic Astrocytoma
Adult Anaplastic Oligodendroglioma
Adult Diffuse Astrocytoma
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Adult Mixed Glioma
Adult Oligodendroglioma
Recurrent Adult Brain Neoplasm
Interventions: Other: Laboratory Biomarker Analysis
Drug: Perifosine
Drug: Temsirolimus
Procedure: Therapeutic Conventional Surgery

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
1 (Temsirolimus: 15 mg/wk) Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
2 (Temsirolimus: 25 mg/wk) Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
3 (Temsirolimus: 50 mg/wk) Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
4 (Temsirolimus: 75 mg/wk) Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
5 (Temsirolimus: 115 mg/wk) Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
6 (Temsirolimus: 170 mg/wk) Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose ) Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28

Participant Flow:   Overall Study
    1 (Temsirolimus: 15 mg/wk)     2 (Temsirolimus: 25 mg/wk)     3 (Temsirolimus: 50 mg/wk)     4 (Temsirolimus: 75 mg/wk)     5 (Temsirolimus: 115 mg/wk)     6 (Temsirolimus: 170 mg/wk)     7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )  
STARTED     4     3     6     3     8     6     6  
COMPLETED     0     0     0     0     1     0     0  
NOT COMPLETED     4     3     6     3     7     6     6  
Physician Decision                 1                 0                 0                 0                 0                 0                 0  
disease progression                 3                 3                 5                 2                 4                 3                 1  
Withdrawal by Subject                 0                 0                 1                 0                 2                 0                 1  
Adverse Event                 0                 0                 0                 1                 1                 3                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1 (Temsirolimus: 15 mg/wk) Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
2 (Temsirolimus: 25 mg/wk) Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
3 (Temsirolimus: 50 mg/wk) Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
4 (Temsirolimus: 75 mg/wk) Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
5 (Temsirolimus: 115 mg/wk) Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
6 (Temsirolimus: 170 mg/wk) Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose ) Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
Total Total of all reporting groups

Baseline Measures
    1 (Temsirolimus: 15 mg/wk)     2 (Temsirolimus: 25 mg/wk)     3 (Temsirolimus: 50 mg/wk)     4 (Temsirolimus: 75 mg/wk)     5 (Temsirolimus: 115 mg/wk)     6 (Temsirolimus: 170 mg/wk)     7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )     Total  
Number of Participants  
[units: participants]
  4     3     6     3     8     6     6     36  
Age  
[units: participants]
               
<=18 years     0     0     0     0     0     0     0     0  
Between 18 and 65 years     4     2     6     3     7     5     5     32  
>=65 years     0     1     0     0     1     1     1     4  
Gender  
[units: participants]
               
Female     1     1     3     2     3     2     0     12  
Male     3     2     3     1     5     4     6     24  
Region of Enrollment  
[units: participants]
               
United States     4     3     6     3     8     6     6     36  



  Outcome Measures

1.  Primary:   Maximum Tolerated Dose of Temsirolimus   [ Time Frame: 28 days ]

2.  Primary:   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)   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Thomas Kaley
Organization: Memorial Sloan Kettering Cancer Center
phone: 212-639-5122
e-mail: kaleyt@mskcc.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01051557     History of Changes
Other Study ID Numbers: NCI-2011-01409
NCI-2011-01409 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MSKCC-09058
09-058
CDR0000663573
09-058 ( Other Identifier: Memorial Sloan-Kettering Cancer Center )
8249 ( Other Identifier: CTEP )
P30CA008748 ( US NIH Grant/Contract Award Number )
U01CA069856 ( US NIH Grant/Contract Award Number )
Study First Received: January 15, 2010
Results First Received: March 17, 2016
Last Updated: July 6, 2016
Health Authority: United States: Food and Drug Administration