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17-AAG in Treating Patients With Inoperable Locoregionally Advanced or Metastatic Thyroid Cancer

2014-08-27 03:53:03 | BioPortfolio

Summary

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.

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.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Head and Neck Cancer

Intervention

tanespimycin

Location

Howard University Cancer Center
Washington
District of Columbia
United States
20060

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:53:03-0400

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