NCT00118248

Brief Summary

This phase II trial is studying how well tanespimycin works in treating patients with inoperable locoregionally advanced or metastatic thyroid cancer. Drugs used in chemotherapy, such as tanespimycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 11, 2005

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

May 6, 2014

Completed
Last Updated

February 15, 2017

Status Verified

December 1, 2016

Enrollment Period

4.7 years

First QC Date

July 8, 2005

Results QC Date

September 20, 2013

Last Update Submit

December 28, 2016

Conditions

Recurrent Thyroid CancerStage IV Follicular Thyroid CancerStage IV Papillary Thyroid CancerThyroid Gland Medullary Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Proportion of Patients Who Have Remained on Treatment and Progression-free at Least One Year After Start of 17-AAG (Tanespimycin)

    The one-year treatment failure free rate is 100% times the proportion of eligible patients who remain on treatment and are progression-free at least one year after treatment start. A 90% confidence interval for the one year treatment failure free rate was constructed using the properties of the binomial confidence interval. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients that are not classified as having a progression are termed progression-free.

    1 year

Secondary Outcomes (4)

  • Overall Response

    Baseline, every 3 courses, and at the end of treatment study

  • Progression-Free Survival

    Every 3 months for up to 3 years

  • Overall Survival

    Every 3 months until progression, and then every 6 months up to 3 years

  • Toxicity

    Every 3 courses during treatment (median cycle number was 5 with a maximum of 38 cycles)

Study Arms (1)

Treatment (chemotherapy)

EXPERIMENTAL

Patients receive tanespimycin 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.

Drug: tanespimycin

Interventions

tanespimycinDRUG

Given IV

Also known as: 17-AAG
Treatment (chemotherapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Performance status - ECOG 0-2
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 9.0 g/dL
  • Bilirubin ≤ normal
  • Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
  • AST ≤ 1.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • +45 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Thyroid NeoplasmsAdenocarcinoma, FollicularThyroid Cancer, PapillaryCarcinoma, Medullary

Interventions

tanespimycin

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeAdenocarcinoma, PapillaryCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve Tissue

Results Point of Contact

Title
Jeffrey F. Moley, M.D.
Organization
Washington University School of Medicine
moleyj@wustl.edu

Study Officials

  • Jeffrey Moley

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2005

First Posted

July 11, 2005

Study Start

December 1, 2004

Primary Completion

August 1, 2009

Study Completion

April 1, 2012

Last Updated

February 15, 2017

Results First Posted

May 6, 2014

Record last verified: 2016-12

Locations

US(1)