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Rapamycin Therapy in Head and Neck Squamous Cell Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )
ClinicalTrials.gov Identifier:
NCT01195922
First received: September 3, 2010
Last updated: January 18, 2017
Last verified: January 2017
Results First Received: October 27, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Mouth Neoplasms
Head and Neck Neoplasms
Tongue Neoplasms
Carcinoma, Squamous Cell
Intervention: Drug: Sirolimus

  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
Subjects were recruited from the National Institute of Health (NIH) as well as the Medical University of South Carolina (MUSC). Recruitment began 5/16/2011 with a total of 37 subjects consented; 34 at MUSC and 3 and NIH. Of the 37 consented, 16 subjects received study intervention and completed the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
37 participants signed consent, 16 participants received study drug.

Reporting Groups
  Description
Sirolimus Rapamycin (sirolimus), dispensed as either tablets or an oral solution for patients with dysphagia was administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Dose reductions to 3 mg by mouth once per day were implemented if levels of rapamycin > 20 ng/ml occurred on Days 8 or 15.

Participant Flow:   Overall Study
    Sirolimus
STARTED   16 
COMPLETED   16 
NOT COMPLETED   0 



  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.
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Reporting Groups
  Description
Sirolimus Rapamycin (sirolimus), which will be dispensed as either tablets or an oral solution for patients with dysphagia (see Section 0), will be administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Serum rapamycin levels will be obtained on Days 8, 15, 22, and 28 (if rapamycin is > 3 ng/ml at Day 28, the subject will return daily, or as is convenient, for testing until rapamycin is ≤ 3 ng/ml). Dose reduction to 3 mg by mouth once per day will occur if trough levels of rapamycin > 20 ng/ml occur on Days 8 or 15 (see Appendix A, Study Calendar for visit windows). If a dose is decreased at Day 8, it will not be increased at Day 15 regardless of serum rapamycin levels. If subjects receiving 3 mg have levels > 20 ng/ml at Day 15, rapamycin will be reduced to 2 mg once per day. Rapamycin will cease on Day 21 regardless of level.

Baseline Measures
   Sirolimus 
Overall Participants Analyzed 
[Units: Participants]
 16 
Age 
[Units: Years]
Median (Standard Deviation)
 63  (11.48) 
Gender 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      16 100.0% 
Region of Enrollment 
[Units: Participants]
 
United States   16 


  Outcome Measures
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1.  Primary:   Percent (%) Change in Levels of pS6, pAKt473, and Ki-67   [ Time Frame: 21 days post treatment with rapamycin ]

2.  Primary:   Percent (%) Changes in Tumor Size, Blood Flow, and Standardized Uptake Value   [ Time Frame: 21 days post treatment with rapamycin ]

3.  Primary:   Percent (%) Change in Clinical and Laboratory Evaluations for Safety   [ Time Frame: Percent (%) change from Pre to Post treatement (~21 days) ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: D. J. Silvio Gutkind
Organization: University of California San Diego
phone: (858) 534 5980
e-mail: sgutkind@ucsd.edu


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )
ClinicalTrials.gov Identifier: NCT01195922     History of Changes
Other Study ID Numbers: 100180
Study First Received: September 3, 2010
Results First Received: October 27, 2016
Last Updated: January 18, 2017