Study Stopped
Lack of funding
Ganetespib Window of Opportunity Study in Head and Neck Cancers
A Molecularly Driven Pilot Study of Preoperative Ganetespib in Resectable Squamous Cell Carcinoma of the Head and Neck (SCCHN)
3 other identifiers
interventional
3
1 country
2
Brief Summary
This pilot clinical trial studies how well ganetespib works before surgery in treating patients with stage I-IVA squamous cell carcinoma of the head and neck that can be removed by surgery. Ganetespib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Studying samples of blood and tissue in the laboratory from patients receiving ganetespib may help doctors learn more about the effects of ganetespib on cells. It may also help doctors understand how well patients respond to treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 6, 2015
CompletedFirst Posted
Study publicly available on registry
January 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedJuly 26, 2016
July 1, 2016
1.2 years
January 6, 2015
July 22, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Change in expression of biomarkers in tissue samples, assessed by immunohistochemistry (IHC)
The biomarker expression of pre-, post-treatment, and their change will be described by summary statistics along with 95% confidence interval (CI) for the estimated mean. A paired sample Wilcoxon signed rank test will be considered to test whether the mean of post-treatment expression is different from the pre-treatment expression. This analysis will be done separately by each of the three dose levels, and by pooling all dose levels together. Kruskal-Wallis test will also be carried out.
Baseline to up to 24 months
Change in biomarker expression in blood samples
The biomarker expression of pre-, post-treatment, as well as their change will be described by summary statistics along with 95% CI for the estimated mean. A paired sample Wilcoxon signed rank test will be considered to test whether the mean of post-treatment expression is different from that of the pre-treatment expression. This analysis will be done separately by each of the three dose levels, as well as by pooling all dose levels together. Kruskal-Wallis test will also be carried out.
Baseline to up to 24 months
Study Arms (1)
Treatment (ganetespib, surgery)
EXPERIMENTALPatients receive ganetespib IV over 1 hour twice weekly for 2 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery the day after the last dose of ganetespib.
Interventions
Given IV
Eligibility Criteria
You may qualify if:
- Patients must have pathologically-confirmed, resectable, squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx
- Disease may be stage I, II, III or IVa (as long as it is deemed resectable by the surgical team)
- Tumor must be surgically resectable and curable with conventional surgery
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patients must give documented informed consent to participate in this study
- Absolute-neutrophil count (ANC) ≥ 1500/mm³
- Platelet count ≥ 100,000/mm³
- Total bilirubin ≤ within upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN
- Creatinine ≤ 1.5 x ULN
- Lipase levels \< 1.5 x ULN
- Amylase levels \< 1.5 x ULN
You may not qualify if:
- Prior therapy with a known heat shock protein 90 (HSP90) inhibitor
- Poor venous access for study drug administration; in this case, patients would require a peripheral or central indwelling catheter for study drug administration; study drug administration via indwelling catheters is prohibited at this time unless silicone based catheters are used; anything other than catheters made from silicone are not allowed with ganetespib therapy
- History of severe allergic or hypersensitivity reactions to excipients (e.g., polyethylene glycol \[PEG\] 300 and polysorbate 80)
- Treatment with chronic immunosuppressant (e.g., cyclosporine following transplantation)
- Uncontrolled undercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study
- Documented evidence of distant metastases or brain metastases
- Active malignancy besides head and neck squamous cell cancer (HNSCC) or primary skin basal cell carcinoma; (patients with a concomitant malignancy that has not progressed within 12 months of study entry are eligible)
- History of documented congestive heart failure (CHF), New York Heart Association class II/III/IV, with a history of dyspnea, orthopnea or edema that requires current treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, beta-blockers or diuretics; NOTE: use of these medications for the treatment of hypertension is allowed
- Peripheral neuropathy that is grade 2 or higher
- Pregnancy or lactation; patients of child bearing age must agree to use adequate contraception
- Patients residing in prison
- Known serious cardiac illness or medical conditions, including but not limited to:
- Clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling temporary pacemaker
- Ventricular tachycardia or a supraventricular tachycardia that requires treatment with a class Ia antiarrhythmic drug (e.g., quinidine, procainamide, disopyramide) or class III antiarrhythmic drug (e.g., sotalol, amiodarone, dofetilide); use of other antiarrhythmic drugs is permitted
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- Synta Pharmaceuticals Corp.collaborator
Study Sites (2)
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nabil F. Saba, MD
Emory University/Winship Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- 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
January 6, 2015
First Posted
January 8, 2015
Study Start
December 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
July 26, 2016
Record last verified: 2016-07