Combination of Temsirolimus and Sorafenib in the Treatment of Radioactive Iodine Refractory Thyroid Cancer

NCT01025453

Last updated date
Study Location
Memorial Sloan-Kettering at Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Thyroid Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients must have histopathologically confirmed at MSKCC thyroid carcinoma of follicular cell origin (D-TC-FCO), which includes papillary, follicular, Hürthle cell histology, or anaplastic along with their respective variants.

- Available pathology for RAF mutational testing (e.g., paraffin block or 5-10 unstained slides). It is not required that mutational testing be completed before starting the clinical study.

- Patients must have surgically inoperable and/or recurrent/metastatic disease.

- Patients must have a PET scan prior to the protocol start date and have at least one FDGavid lesion that has not been removed surgically or radiated (unless it has progressed by RECIST criteria after the completion of radiation therapy and is still FDG-avid). FDGavidity will be defined as any focus of increased FDG uptake greater than normal activity with SUV maximum levels greater than or equal to 3. PET scan can have been done at any time prior to the start of therapy, although it is recommended that it be done within 3 months prior to the start of therapy.

- Patients must have measurable disease by RECIST criteria, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan; performed ≤ 4 weeks of protocol start date.

- Patients must have progressive disease defined by at least one of the following occurring during or after previous treatment (including RAI treatment):

- The presence of new or progressive lesions on CT/MRI.

- New lesions on bone scan or PET scan.

- Rising thyroglobulin level (documented by a minimum of three consecutive rises, with an interval of > 1 week between each determination).

- Prior RAI therapy is allowed if > 3 months prior to initiation of therapy on this protocol and evidence of progression (as defined above) has been documented in the interim. A diagnostic study using <10 mCi of RAI is not considered RAI therapy.

- Patients may have received prior external beam radiation therapy to index lesions ≥ 4 weeks prior to initiation of therapy on this protocol if there has been documented progression by RECIST criteria. Prior external beam radiation therapy to the non-index lesions is allowed if ≥ 4 weeks prior to initiation of therapy on this protocol.

- ECOG performance status ≤ 2 (or Karnofsky performance status ≥ 60%).

- Patients must have normal organ and marrow function as defined below:

- Absolute neutrophil count ≥1,500/mcL

- Platelets ≥100,000/mcL

- Total bilirubin ≤ 1.5 X institutional ULN

- AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional ULN

- Creatinine ≤ 1.5 X institutional ULN OR

- Creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above 1.5 X institutional ULN [in this circumstance, either of a measured level based on a 24 hour urine collection, or a calculated level using the Cockcroft and Gault equation: (140 - age in years) X (weight in kg) X (0.85 if female)/72 X serum Cr may be used].

- International normalized ratio (INR) ≤ 1.5 (or in range INR, usually between 2 and 3, if patient is on a stable dose of therapeutic warfarin).

- *ULN = upper limit of normal

- **unless liver metastasis present in which AST/ALT should be < 5 x ULN.

- Ability to understand and the willingness to sign a written informed consent document.

- Age 21 years old or older.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Patients may not be receiving any other investigational agents.


- Patients with known history of active intraparenchymal brain metastasis within
previous 3 months.


- Serious or non-healing wound, ulcer, or bone fracture.


- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
within 28 days of treatment.


- Patients with a reported history of clinically active diverticulosis or diverticulitis
in the prior 3 years.


- Patients with clinically significant cardiovascular disease as defined by the
following:


- History of CVA within past 6 months


- Myocardial infarction, CABG or unstable angina within past 6 months


- New York Heart Association grade III or greater congestive heart failure or Canadian
Cardiovascular Class grade III or greater angina within past 6 months (Appendices B&C)
Clinically significant peripheral vascular disease within past 6 months


- Pulmonary embolism, DVT, or other thromboembolic event within past 6 months


- Uncontrolled coronary artery disease, angina, congestive heart failure, or ventricular
arrhythmia requiring acute medical management within past 6 months


- History of myocardial infarct, cerebrovascular accident, or transient ischemic event
within the past 6 month


- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection or psychiatric illness/social situations that would limit compliance with
study requirements.


- While the use of Angiotensin-Converting Enzyme (ACE) inhibitors is not absolutely
excluded, efforts should be made to see if patients on ACE inhibitors can be taken off
the medication or switched to another medication.


- Pregnant women will be ineligible; breastfeeding should be discontinued if the mother
is treated with study drugs.


- The use of agents that inhibit or induce CYP3A metabolism is not strictly prohibited,
but should be avoided if possible. Potential CYP3A inducing agents include
carbamazepine, phenytoin, barbiturates, rifabutin, rifampicin, and St. John's Wort.
Potential CYP3A inhibitors include protease inhibitors, antifungals, macrolide
antibiotics, nefazodone, and selective serotonin inhibitors.

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  1. Ann Arbor, Michigan
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Thyroid CancerCombination of Temsirolimus and Sorafenib in the Treatment of Radioactive Iodine Refractory Thyroid Cancer
NCT01025453
  1. Basking Ridge, New Jersey
  2. Commack, New York
  3. New York, New York
  4. Rockville Centre, New York
  5. Sleepy Hollow, New York
ALL GENDERS
21 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Combination of Temsirolimus and Sorafenib in the Treatment of Radioactive Iodine Refractory Thyroid Cancer
Official Title  ICMJE Phase II Study Evaluating the Combination of Temsirolimus and Sorafenib in the Treatment of Radioactive Iodine Refractory Thyroid Cancer
Brief Summary

The purpose of this study is to find out what effects, good and/or bad, the combination of sorafenib and temsirolimus will have on thyroid cancer. Treatment guidelines from the National Comprehensive Cancer Network include sorafenib as a treatment option for thyroid cancer.

Temsirolimus is an intravenous medication that is FDA approved for other type of cancers. In laboratory studies, the addition of temsirolimus to sorafenib works better than sorafenib alone.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thyroid Cancer
Intervention  ICMJE Drug: Temsirolimus and Sorafenib
Treatment will be with sorafenib 200 mg orally twice a day and temsirolimus 25 mg intravenous weekly. A cycle will be equivalent to 4 weeks of treatment.
Study Arms  ICMJE Experimental: Pts getting Temsirolimus and Sorafenib
We propose a phase II study to evaluate the efficacy of the combination sorafenib with temsirolimus in patients with thyroid cancer of follicular cell origin (e.g., papillary, follicular, Hurthle cell). A maximum of 36 subjects will be evaluated during the study. Restaging scans, with evaluation of response, will be done every 2 cycles (8 weeks of treatment). Treatment will continue until clinical disease progression, unacceptable toxicity, treatment delay > 4 weeks, or at the discretion of the treating physician or patient.
Intervention: Drug: Temsirolimus and Sorafenib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2018)
37
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2009)
40
Actual Study Completion Date  ICMJE January 16, 2018
Actual Primary Completion Date January 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have histopathologically confirmed at MSKCC thyroid carcinoma of follicular cell origin (D-TC-FCO), which includes papillary, follicular, Hürthle cell histology, or anaplastic along with their respective variants.
  • Available pathology for RAF mutational testing (e.g., paraffin block or 5-10 unstained slides). It is not required that mutational testing be completed before starting the clinical study.
  • Patients must have surgically inoperable and/or recurrent/metastatic disease.
  • Patients must have a PET scan prior to the protocol start date and have at least one FDGavid lesion that has not been removed surgically or radiated (unless it has progressed by RECIST criteria after the completion of radiation therapy and is still FDG-avid). FDGavidity will be defined as any focus of increased FDG uptake greater than normal activity with SUV maximum levels greater than or equal to 3. PET scan can have been done at any time prior to the start of therapy, although it is recommended that it be done within 3 months prior to the start of therapy.
  • Patients must have measurable disease by RECIST criteria, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ? 20 mm with conventional techniques or as ? 10 mm with spiral CT scan; performed ? 4 weeks of protocol start date.
  • Patients must have progressive disease defined by at least one of the following occurring during or after previous treatment (including RAI treatment):
  • The presence of new or progressive lesions on CT/MRI.
  • New lesions on bone scan or PET scan.
  • Rising thyroglobulin level (documented by a minimum of three consecutive rises, with an interval of > 1 week between each determination).
  • Prior RAI therapy is allowed if > 3 months prior to initiation of therapy on this protocol and evidence of progression (as defined above) has been documented in the interim. A diagnostic study using <10 mCi of RAI is not considered RAI therapy.
  • Patients may have received prior external beam radiation therapy to index lesions ? 4 weeks prior to initiation of therapy on this protocol if there has been documented progression by RECIST criteria. Prior external beam radiation therapy to the non-index lesions is allowed if ? 4 weeks prior to initiation of therapy on this protocol.
  • ECOG performance status ? 2 (or Karnofsky performance status ? 60%).
  • Patients must have normal organ and marrow function as defined below:
  • Absolute neutrophil count ?1,500/mcL
  • Platelets ?100,000/mcL
  • Total bilirubin ? 1.5 X institutional ULN
  • AST(SGOT)/ALT(SGPT) ? 2.5 X institutional ULN
  • Creatinine ? 1.5 X institutional ULN OR
  • Creatinine clearance ? 60 mL/min/1.73 m2 for patients with creatinine levels above 1.5 X institutional ULN [in this circumstance, either of a measured level based on a 24 hour urine collection, or a calculated level using the Cockcroft and Gault equation: (140 - age in years) X (weight in kg) X (0.85 if female)/72 X serum Cr may be used].
  • International normalized ratio (INR) ? 1.5 (or in range INR, usually between 2 and 3, if patient is on a stable dose of therapeutic warfarin).
  • *ULN = upper limit of normal
  • **unless liver metastasis present in which AST/ALT should be < 5 x ULN.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Age 21 years old or older.

Exclusion Criteria:

  • Patients may not be receiving any other investigational agents.
  • Patients with known history of active intraparenchymal brain metastasis within previous 3 months.
  • Serious or non-healing wound, ulcer, or bone fracture.
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment.
  • Patients with a reported history of clinically active diverticulosis or diverticulitis in the prior 3 years.
  • Patients with clinically significant cardiovascular disease as defined by the following:
  • History of CVA within past 6 months
  • Myocardial infarction, CABG or unstable angina within past 6 months
  • New York Heart Association grade III or greater congestive heart failure or Canadian Cardiovascular Class grade III or greater angina within past 6 months (Appendices B&C) Clinically significant peripheral vascular disease within past 6 months
  • Pulmonary embolism, DVT, or other thromboembolic event within past 6 months
  • Uncontrolled coronary artery disease, angina, congestive heart failure, or ventricular arrhythmia requiring acute medical management within past 6 months
  • History of myocardial infarct, cerebrovascular accident, or transient ischemic event within the past 6 month
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements.
  • While the use of Angiotensin-Converting Enzyme (ACE) inhibitors is not absolutely excluded, efforts should be made to see if patients on ACE inhibitors can be taken off the medication or switched to another medication.
  • Pregnant women will be ineligible; breastfeeding should be discontinued if the mother is treated with study drugs.
  • The use of agents that inhibit or induce CYP3A metabolism is not strictly prohibited, but should be avoided if possible. Potential CYP3A inducing agents include carbamazepine, phenytoin, barbiturates, rifabutin, rifampicin, and St. John's Wort. Potential CYP3A inhibitors include protease inhibitors, antifungals, macrolide antibiotics, nefazodone, and selective serotonin inhibitors.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01025453
Other Study ID Numbers  ICMJE 09-148
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE
  • National Comprehensive Cancer Network
  • Pfizer
Investigators  ICMJE
Principal Investigator:Eric Sherman, MDMemorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP