Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2014-04-30

Brief Summary

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This phase II trial is studying how well bortezomib works in treating patients with metastatic thyroid cancer that did not respond to radioactive iodine therapy. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Detailed Description

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PRIMARY OBJECTIVE:

I. Determine the efficacy of bortezomib, in terms of tumor response rate, in patients with metastatic papillary or follicular thyroid cancer unresponsive to prior radioiodine therapy.

SECONDARY OBJECTIVE:

I. Determine the clinical activity of this drug, in terms of progression-free survival, in patients treated with this drug.

OUTLINE: This is an open-label, multicenter study. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.

Conditions

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Insular Thyroid Cancer Recurrent Thyroid Cancer Stage II Follicular Thyroid Cancer Stage II Papillary Thyroid Cancer Stage IV Follicular Thyroid Cancer Stage IV Papillary Thyroid Cancer

Keywords

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National Thyroid Cancer Treatment Cooperative Study Group NTCTCSG bortezomib velcade metastatic differentiated thyroid carcinoma Differentiated thyroid carcinoma follicular epithelial thyroid cells papillary oxyphilic cell Hurthle cell insular cell columnar cell tall cell

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bortezomib

Bortezomib 1.3 mg/m\^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.

Group Type EXPERIMENTAL

Bortezomib

Intervention Type DRUG

Administered IV at the dose of 1.3 mg/m\^2 on a twice-weekly schedule for 2 consecutive weeks on days 1, 4, 8, and 11, followed by a 10 day rest period on days 12-21 (one cycle). In the absence of clinical progression, treatment continued for a minimum of 4 treatment cycles (or 12 weeks).

Interventions

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Bortezomib

Administered IV at the dose of 1.3 mg/m\^2 on a twice-weekly schedule for 2 consecutive weeks on days 1, 4, 8, and 11, followed by a 10 day rest period on days 12-21 (one cycle). In the absence of clinical progression, treatment continued for a minimum of 4 treatment cycles (or 12 weeks).

Intervention Type DRUG

Other Intervention Names

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LDP 341 MLN341 VELCADE

Eligibility Criteria

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Inclusion Criteria

* The Eastern Cooperative Oncology Group (ECOG) 0-2 OR Karnofsky 60-100%
* Platelet count \>= 100,000/mm\^3
* Absolute neutrophil count \>= 1,500/mm\^3
* White Blood Count (WBC) \>= 3,000/mm\^3
* Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) =\< 2.5 times upper limit of normal
* Bilirubin normal
* No symptomatic congestive heart failure
* Creatinine normal OR creatinine clearance \>= 60 mL/min
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* No other uncontrolled illness
* At least 4 weeks since prior chemotherapy
* No more than 2 prior chemotherapy regimens
* At least 6 months since prior external beam radiotherapy for locoregional disease in the thyroid bed or to the cervical or upper mediastinal lymph nodes (dose =\< 6,000 cGy)
* At least 6 months since prior radioiodine therapy
* No prior external radiotherapy to the measured tumor
* Prior thyroidectomy allowed
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent investigational agents
* No other concurrent anticancer therapy
* Unresponsive to prior radioiodine therapy
* Histologically confirmed differentiated thyroid cancer-papillary or follicular type, including, but not limited to, any of the following variants: hurthle cell (oxyphilic), insular, columnar cell, tall cell
* Metastatic disease
* At least 1 unidimensionally measurable lesion \>= 20 mm by conventional techniques OR \>= 10 mm by spiral CT scan
* No prior radiotherapy to the only measurable lesion
* No radioiodine uptake in the measured metastatic tumor by radioiodine scan (Note: Must have had \>= 1 radioiodine scan since the last radioiodine treatment)
* No known brain metastases

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Sherman

Role: PRINCIPAL_INVESTIGATOR

The University of Texas MD Anderson Cancer Center

Locations

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University of Colorado at Denver Health Sciences Center

Aurora, Colorado, United States

Site Status

Lombardi Comprehensive Cancer Center at Georgetown University

Washington D.C., District of Columbia, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Site Status

Dana-Farber Harvard Cancer Center

Boston, Massachusetts, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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Canada United States