Trial Evaluating Gleevec in Patients With Anaplastic Thyroid Carcinoma

NCT00115739 | Terminated Phase 2 Results DMC

• 2 other identifiers: UMCC 2003-044IRBMED number 2003-0701
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Anaplastic thyroid cancers are rare, aggressive tumors. Standard treatment options include surgery and chemoradiation. Few treatment options are available once metastases develop. Recent data suggest that Imatinib (Gleevec) may be advantageous in this patient population. Patients who have been treated for anaplastic thyroid cancer with chemoradiation or surgery who develop recurrent or metastatic disease outside of the field of radiation are eligible. Patients will be treated with Imatinib 400 mg two times a day for eight weeks, followed by radiologic assessment. Patients will be treated until disease progression or a complete response is obtained.

Conditions

Thyroid Cancer

Keywords

Anaplastic Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Response (Complete and Partial Response) Rate at 8 Weeks

  The number of patients with Complete Response (CR), Partial Response (PR) and Stable Disease (SD) were determined at 8 weeks.

  8 weeks

Secondary Outcomes (3)

• Rate of Grade 3, Grade 4 and Grade 5 Toxicities Experienced by Patients With Anaplastic Thyroid Cancer Who Are Treated With Gleevec

  Up to 30 days post treatment

• 6 Month Progression Free Survival Rate

  6 months

• 6 Month Survival Rate

  6 months

Study Arms (1)

Imatinib

EXPERIMENTAL

Patients will be treated with Imatinib (Gleevec) 400 mg two times a day for eight weeks after which radiologic imaging will be obtained to assess response. Patients who attained a complete response will be treated with four additional weeks of Imatinib. Patients who attain a partial response or stable disease will be treated until a complete response is attained, or until disease progression. All patients with progression of disease will be taken off the study. Patients continuing on the study, will undergo radiologic imaging every eight weeks following their initial response assessment. All patients will be followed until death.

Drug: Imatinib

Interventions

Imatinib DRUG

Imatinib 400 mg capsules were administered twice daily with food for 4 week cycles.

Also known as: Gleevec

Imatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically confirmed anaplastic thyroid carcinoma, who have measurable disease.
• Patients with brain metastases are eligible if they have been stable for at least six weeks post-radiation therapy.
• Age 18 years, male or female.
• Karnofsky performance status (KPS) of \> 70%.
• Life expectancy of at least 12 weeks.
• Hematologic: ANC 1,500 mm3, hemoglobin 8.0 g/dl, platelets 100,000/mm3
• Normal serum calcium level within normal limits for the institution documented within 14 days prior to registration.
• All patients (including those with liver metastases) must have adequate hepatic function as defined by a serum bilirubin 1.5 x the institutional upper limit of normal (ULN), and ALT and AST \<2.5 x ULN, obtained within 14 days prior to registration.
• Patients must have a serum creatinine less than 1.5 x the institutional upper limits of normal (adjusted for age) within 14 days of registration.
• Women of childbearing potential must have a negative pregnancy test at baseline, prior to receiving any study drug. (Pregnant or lactating patients are excluded.)
• Patients of reproductive potential must practice effective contraception while on study and for at least six months after receiving the last dose of study drug.
• All patients must sign an informed consent prior to enrollment.
• No prior history of non-thyroid malignancy, except adequately treated skin cancer or in situ cervical carcinoma or any other cancer in complete remission for at least two years.
• Prior chemotherapy, chemoradiation, radiation therapy, or surgery must have been completed at least 28 days prior to registration, and all toxicities must have resolved. Patients who have been treated with nitrosourea or mitomycin C must be off of these drugs for at least 6 weeks prior to registration.
• Patients must be able to take oral medications.

You may not qualify if:

• Anaplastic thyroid cancer that does not overexpress PDGF receptors or c-Abl by immunohistochemistry
• Any medical or psychiatric illness which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment regimen.
• No concurrent radiotherapy (to the primary tumor) or chemotherapy may be given to the patient during the administration of the study drug.
• Pregnant or lactating women, women of childbearing potential with either a positive pregnancy test (PPT) at baseline, or sexually active females not using reliable contraceptive methods while on study and for at least six months after chemotherapy. (Postmenopausal women must have been amenorrheic for least 12 months to be considered of non-childbearing potential).
• Sexually active males not using reliable contraceptive methods while on the study and for at least six months after chemotherapy.
• Patients with malabsorption syndromes will be excluded.
• Serious concurrent infections.
• Patients who have had previous organ allografts will be excluded.
• Prisoners.
• Patients with chronic liver disease (i.e chronic active hepatitis and cirrhosis).
• Patients with a known diagnosis of human immunodeficiency virus (HIV) infection.
• Patients who have had major surgery within 2 weeks of study entry.
• Patients with grade III/IV cardiac problems as defined by the New York Heart Association Criteria (i.e. congestive heart failure, myocardial infarction within 6 months of study entry).

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Carcinoma, Anaplastic

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Limitations and Caveats

Study was closed early due to slow accrual. Planned accrual was 28

Results Point of Contact

• Title: Frances Worden, M.D.
• Organization: University of Michigan Comprehensive Cancer Center

fworden@umich.edu

(734) 615-6633

Study Officials

• Francis P Worden, MD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2005
• First Posted: June 24, 2005
• Study Start: February 1, 2004
• Primary Completion: May 1, 2008
• Study Completion: August 1, 2010
• Last Updated: April 21, 2014
• Results First Posted: April 21, 2014

Record last verified: 2014-03

Locations

US (1)