ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 31 of 539 for:    cutaneous [CONDITION] AND "lymphoma "[CONDITION]

Everolimus in Treating Cutaneous T-cell Lymphoma (CTCL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01637090
Recruitment Status : Terminated (Poor enrollment)
First Posted : July 10, 2012
Results First Posted : October 31, 2016
Last Update Posted : January 12, 2017
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Adam Lerner, Boston Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cutaneous T-Cell Lymphoma
Intervention Drug: Everolimus
Enrollment 3
Recruitment Details This study was actively recruiting from within the investigator's own praceice from June 2012 through May 2015 in the hematology/oncology multidisciplinary clinic.
Pre-assignment Details  
Arm/Group Title All Patients on Study
Hide Arm/Group Description

Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.

This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.

Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity.

Period Title: Overall Study
Started 3
Completed 0
Not Completed 3
Arm/Group Title All Patients on Study
Hide Arm/Group Description

Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.

This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.

Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity.

Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  33.3%
>=65 years
2
  66.7%
[1]
Measure Description: greater than or equal to 18 years
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
0
   0.0%
Male
3
 100.0%
1.Primary Outcome
Title Efficacy of Treatment
Hide Description Determine the efficacy of everolimus in the treatment of CTCL as overall response rate (ORR)
Time Frame 12 months after beginning treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was pre-maturely terminated. No data were collected for the Outcome Measure
Arm/Group Title All Patients on Study
Hide Arm/Group Description:

Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.

This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.

Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Time to Response
Hide Description Determine time to response (TTR)/duration of objective response (DOR)
Time Frame three months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was pre-maturely terminated. No data were collected for the Outcome Measure
Arm/Group Title All Patients on Study
Hide Arm/Group Description:

Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.

This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.

Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Progression-free Survival
Hide Description Determine progression-free survival of CTCL patients treated with everolimus
Time Frame two years after discontinuing study treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was pre-maturely terminated. No data were collected for the Outcome Measure
Arm/Group Title All Patients on Study
Hide Arm/Group Description:

Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.

This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.

Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Hide Description Determine the adverse event profile and tolerability of everolimus in patients with CTCL
Time Frame Up to one year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients on Study
Hide Arm/Group Description:

Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.

This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.

Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity.

Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
3
5.Secondary Outcome
Title Effect of mTOR on Tumors
Hide Description Determine mTOR (mammilian target of rapamycin) pathway activation and number of regulatory T cells (Tregs) in pre-treated tumor tissue and evaluate changes following treatment
Time Frame one year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was pre-maturely terminated. No data were collected for the Outcome Measure
Arm/Group Title All Patients on Study
Hide Arm/Group Description:

Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.

This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.

Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event reporting was to be collected for up to one year.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Patients on Study
Hide Arm/Group Description

Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.

This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.

Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity.

All-Cause Mortality
All Patients on Study
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Patients on Study
Affected / at Risk (%) # Events
Total   3/3 (100.00%)    
General disorders   
fatigue * 1  1/3 (33.33%)  1
Infections and infestations   
skin infection * 1 [1]  1/3 (33.33%)  1
Skin and subcutaneous tissue disorders   
pruritis * 1  1/3 (33.33%)  1
Rash * 1  1/3 (33.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
cellulitis
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Patients on Study
Affected / at Risk (%) # Events
Total   0/3 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Adam Lerner, MD
Organization: Boston Medical Center
Phone: 617-638-8265
Responsible Party: Adam Lerner, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01637090     History of Changes
Other Study ID Numbers: H-30213
First Submitted: April 2, 2012
First Posted: July 10, 2012
Results First Submitted: September 12, 2016
Results First Posted: October 31, 2016
Last Update Posted: January 12, 2017