Imaging HSP90 Inhibitor AUY922 on VEGF-89ZR-bevacizumab Positron Emission Tomography (PET)

Breast Cancer Clinical Trial

Official title:

Imaging the Effect of HSP90 Inhibitor AUY922 on VEGF by Means of 89Zr-bevacizumab PET

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01081613
• Other study ID #: CAUY922A2101
• Secondary ID: 2008-005752-25
• Status: Completed
• Phase: N/A
• First received: March 4, 2010
• Last updated: September 5, 2012
• Start date: February 2010
• Est. completion date: February 2012

Study information

• Verified date: September 2012
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

Inhibition of Heat Shock Protein (HSP)90 is a new, promising treatment modality for cancer patients, particularly in the setting of resistance. A reliable read out system (biomarker) for the evaluation of early treatment effect is of great importance in the development of this treatment modality, and could contribute to customize this treatment for individual patients. So far, no reliable biomarker has been described for HSP90 effect. Visualizing the effect of HSP90 on vascular endothelial growth factor (VEGF) secretion in vivo in the patient, by whole body 89Zr-bevacizumab uptake, can be of great importance in this respect, and may contribute to tailored made cancer treatment. The purpose of the present study is to evaluate the effect of HSP90 inhibition by AUY922 on VEGF by means of 89ZR-bevacizumab PET.

Description:

This feasibility study is designed as a side study to the multicenter, international phase I-II trial with HSP90 inhibitor AUY922 (protocol CAUY922A2101), as part of the biomarker assessment. In protocol CAUY922A2101, section 4, the design of this phase I-II trial is described (p37, 38). Briefly, a dose-escalation study is performed according to phase I design in adult patients with advanced solid malignancies. This part is followed by a dose-expansion study according to a phase II design. In the latter part, breast cancer patients are enrolled that are either refractory to hormone- or trastuzumab treatment (both treatment arms, n=40 patients), on the maximal tolerated dose of AUY922 based on the phase I part of the study. Patients with ER positive, hormone therapy refractory breast cancer, will receive a 89Zr-bevacizumab PET scan as part of the present side study protocol, which will be performed in collaboration with the Royal Marsden Hospital (United Kingdom).

To this end, a 89Zr-bevacizumab PET scan will be performed before (baseline) and during treatment with HSP90 inhibitor AUY922, as described below.

A minimum of six patients will be entered to evaluate whether the effect of HSP90 inhibition by AUY922 can be detected with a 89Zr-bevacizumab PET scan

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with ER positive, hormone therapy refractory breast cancer

• participation in the phase I-II trial with HSP90 inhibitor AUY922 (in- and exclusion criteria for the study with AUY922 are described in protocol CAUY922A2101, Clinical Trials no NCT00526045A.

Exclusion Criteria:

• no participation in the phase I-II trial with HSP90 inhibitor AUY922

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• 89Zr-bevacizumab PET imaging
injection 89Zr-bevacizumab and 89 Zr-bevacizumab PET scan

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effect of HSP90 inhibition by AUY922 on VEGF by means of 89Zr-bevacizumab PET.	Primary endpoint: measurement of decreased VEGF compared to baseline. A decline is defined as a decrease of at least 30% in mean Standardized Uptake Value (SUV) in a maximum of three lesions.	2 years	No