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17-AAG in Treating Patients With Inoperable Locoregionally Advanced or Metastatic Thyroid Cancer
This study is ongoing, but not recruiting participants.
First Received: July 8, 2005   Last Updated: June 26, 2009   History of Changes
Sponsors and Collaborators: Mayo Clinic
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00118248
  Purpose

RATIONALE: Drugs used in chemotherapy, such as 17-AAG, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well 17-AAG works in treating patients with inoperable locoregionally advanced or metastatic thyroid cancer.


Condition Intervention Phase
Head and Neck Cancer
Drug: tanespimycin
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial of 17-Allylaminogeldanamycin (17AAG) in Advanced Medullary and Differentiated Carcinoma of the Thyroid

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Treatment failure at 1 year [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Overall survival [ Designated as safety issue: No ]
  • Time to disease progression [ Designated as safety issue: No ]
  • Overall response rate (complete and partial) [ Designated as safety issue: No ]
  • Correlation of the incidence rate of RAS, RAF, and RET mutations with clinical response [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: December 2004
Estimated Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the 1-year treatment failure rate in patients with inoperable locoregionally advanced or metastatic medullary or differentiated thyroid carcinoma treated with 17-N-allylamino-17-demethoxygeldanamycin (17-AAG).

Secondary

  • Determine the toxicity of this drug in these patients.
  • Determine the 1-year progression-free rate in patients treated with this drug.
  • Determine the response rate and duration of response in patients treated with this drug.
  • Determine the time to treatment failure and time to subsequent therapy in patients treated with this drug.
  • Determine the time to disease progression and overall survival of patients treated with this drug.
  • Correlate the incidence rate of RAS, RAF, and RET mutations with clinical outcome in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to type of thyroid carcinoma (medullary vs differentiated).

Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 4, 8, and 11.

Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years from study entry.

PROJECTED ACCRUAL: A total of 28-72 patients (14-36 per stratum) will be accrued for this study within 24 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of thyroid carcinoma of 1 of the following types:

    • Medullary
    • Differentiated

      • Iodine I 131-resistant disease, defined as failure to incorporate and/or progression of measurable disease after treatment with iodine I 131
  • Inoperable locoregionally advanced or metastatic disease
  • Measurable disease, defined as ≥ 1 lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
  • No active CNS metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL

Hepatic

  • Bilirubin ≤ normal
  • Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
  • AST ≤ 1.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • QTc < 450 msec for male patients (470 msec for female patients)
  • LVEF > 40% by MUGA
  • DLCO ≥ 80%
  • No cardiac symptoms ≥ grade 2
  • No active ischemic heart disease within the past year
  • No congenital long QT syndrome
  • No left bundle branch block
  • No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
  • No myocardial infarction within the past year
  • No New York Heart Association class III or IV congestive heart failure
  • No poorly controlled angina
  • No history of angina (of any sort) within the past 6 months
  • No history of uncontrolled dysrhythmias or requiring antiarrhythmic drugs
  • No history of cardiac toxicity after treatment with anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride, bleomycin, or carmustine)
  • No other significant cardiac disease

Immunologic

  • No uncontrolled infection
  • No history of serious allergic reaction to eggs

Pulmonary

  • No pulmonary symptoms ≥ grade 2
  • No symptomatic pulmonary disease requiring medication including the following:

    • Dyspnea on or off exertion
    • Paroxysmal nocturnal dyspnea
    • Oxygen requirement
    • Significant pulmonary disease (e.g., chronic obstructive/restrictive pulmonary disease)
  • No home oxygen need meeting the Medicare criteria
  • No history of pulmonary toxicity after treatment with anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride, bleomycin, or carmustine)

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma
  • No active seizure disorder

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior and no concurrent immunotherapy
  • More than 4 weeks since prior biologic therapy
  • No concurrent routine or prophylactic colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])

Chemotherapy

  • More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior and no concurrent radiotherapy
  • More than 4 weeks since prior radiopharmaceuticals
  • No prior radiotherapy to > 25% of bone marrow
  • No prior radiotherapy that potentially included the heart in the field (i.e., mantle) or chest

Surgery

  • More than 4 weeks since prior therapeutic surgery for the tumor

Other

  • More than 3 months since prior sublingual nitroglycerin
  • No other concurrent investigational ancillary therapy
  • Concurrent CYP3A4 inhibitors allowed
  • No concurrent medications that prolong or may prolong QTc interval
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00118248

Locations
United States, District of Columbia
Howard University Cancer Center
Washington, District of Columbia, United States, 20060
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1240
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
China
Prince of Wales Hospital
Hong Kong, China
Singapore
Cancer Institute at National University Hospital
Singapore, Singapore, 119074
Johns Hopkins Singapore International Medical Centre
Singapore, Singapore, 308433
National Cancer Centre - Singapore
Singapore, Singapore, 169610
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Jeffrey F. Moley, MD Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Investigator: Robert C. Smallridge, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Mayo Clinic Cancer Center ( Charles Erlichman )
Study ID Numbers: CDR0000433150, MAYO-MC0476, NCI-6482, JHOC-JS0652, JHOC-B/06/174
Study First Received: July 8, 2005
Last Updated: June 26, 2009
ClinicalTrials.gov Identifier: NCT00118248     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV papillary thyroid cancer
stage IV follicular thyroid cancer
thyroid gland medullary carcinoma
recurrent thyroid cancer

Study placed in the following topic categories:
Adenocarcinoma, Follicular
Carcinoma, Medullary
Thyroid Neoplasms
Thyroid Cancer, Papillary
Thyroid Cancer, Medullary
Endocrine System Diseases
Recurrence
Carcinoma
Thyroid Cancer, Follicular
Head and Neck Neoplasms
Endocrinopathy
Thyroid Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Thyroid Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 09, 2009