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89Zr-RO5323441 PET Imaging in Glioblastoma

NCT01622764 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-05-06

No results posted yet for this study

Summary

The research the investigators propose is a molecular imaging study of RO5323441, an antibody against placental growth factor (PlGF) in patients with recurrent GBM treated with bevacizumab, a drug against vascular endothelial growth factor (VEGF). Both VEGF and PlGF are molecules involved in tumor growth since they enable the development of tumor vasculature, thus delivery of oxygen and nutrients to the tumor. The treatment will consist of bevacizumab (i.v.) given every 2 weeks, until the patient has clinical benefit (no disease progression) or unacceptable toxicity. Meanwhile, patients will receive and injection of low protein-dose radiolabeled RO5323441 (89Zr-RO5323441) on day -3 and 11 of the first bevacizumab treatment cycle. Brain-only 89Zr-RO5323441 positron emission tomography (PET) will be performed at 2 hours after each injection of 89Zr-RO5323441 on day -3 and 11. Whole body 89Zr-RO5323441 PET will be performed on day 1 and 15, before and after the first treatment with bevacizumab. The main purpose of this trial is to determine how much of RO5323441 actually gets into the recurrent GBM lesions, since for a drug to be active, it has to be able to reach cancer cells. As second aims, RO5323441 accumulation in normal, non-tumor organs, will be assessed, as well as how bevacizumab influences RO5323441 penetration into tumor lesions (to answer the question of combined bevacizumab + RO5323441 treatment in GBM) or RO5323441 biodistribution in non-tumor organs.

Conditions

Interventions

RADIATION

Molecular imaging with 89Zr-RO5323441

Bevacizumab at a dose of 10 mg/kg body weight i.v. in 90 min on day 1 will be given every 2 weeks in cycles of 6 weeks, until documented disease progression, unacceptable toxicity, patient refusal or patient's best interest. 89Zr-RO5323441 will be administered i.v. at a tracer dose of 5 mg (37 MBq) on day -3 and on day 11 of cycle 1 of bevacizumab treatment. Four PET scans will be performed (2 brain only PET scans and 2 whole body PET scans). Brain only PET scans will be performed 2 hours after each 89Zr-RO5323441 administration on day -3 and day 11. Whole body PET scans will be performed 4 days after each 89Zr-RO5323441 administration (before dosing with bevacizumab on day 1 and day 15).

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Annemiek M. Walenkamp, MD, PhD · University Medical Center Groningen

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-09-30
Completion
2016-09-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01622764 on ClinicalTrials.gov