Stereotactic Radiosurgery With Sunitinib for Brain Metastases

NCT00981890 | Completed Phase 1 DMC

• 1 other identifier: UHN REB 09-0115-C
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the maximum dose of sunitinib that can be tolerated when treatment is combined with radiotherapy. Patients who decide to take part in the study will start taking sunitinib alone for 7 days. On the seventh day of taking sunitinib, patients will be given stereotactic radiosurgery (SRS). The dose of radiation that patients will receive when they are given SRS is a standard dose used to help shrink brain metastases. The dose of radiation and the way it is delivered is not experimental. Patients will then continue to take sunitinib seven days per week after SRS, and depending on how far along the study is when they join, they may continue taking the drug for up to 13 weeks after SRS. Patients will undergo weekly assessment during study treatment.

Conditions

Brain Metastases

Keywords

Brain Metastases; Stereotactic radiosurgery; Sunitinib; Patients with Brain Metastases

Outcome Measures

Primary Outcomes (1)

• Determine the safety and maximum tolerated dose of Sunitinib when combined concurrently with SRS in patients with 1-3 brain metastases

  2 years

Secondary Outcomes (1)

• Assess: late toxicities/Tx effect on cognitive function/potential prognostic factors/time to Intracranial Local & Distant Progression/brain Progression-free Survival/alterations in tumour perfusion parameters & effects in normal brain tissue

  2 years

Study Arms (1)

Sunitinib

EXPERIMENTAL

Drug: Sunitinib

Interventions

Sunitinib DRUG

Sunitinib is a tablet that is taken by mouth every day. Patients will be treated with Sunitinib alone for 7 days. On the seventh day of taking the drug they will be given SRS. Sunitinib will continue for seven days per week after SRS, and depending on how far along the study is when patients join, they may continue taking the drug for up to 13 weeks after SRS.

Sunitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy proven malignancy (original biopsy is adequate as long as the brain imaging is consistent with brain metastases).
• Patients age 18 years of age or older, as the effects of Sunitinib at the recommended therapeutic dose are unknown in children.
• A contrast-enhanced MRI demonstrating the presence of 1-3 brain metastases performed within four weeks prior to registration.
• The dominant contrast-enhancing intraparenchymal brain metastases must be well-circumscribed and must have a maximal diameter of ≤ 4.0 cm in any direction on the enhanced scan. If multiple lesions are present and one lesion is at the maximum diameter, the other(s) must not exceed 3.0cm in maximum diameter.
• Life expectancy \> 3 months
• RPA Class 1 and RPA Class 2 patients with stable primary disease
• No systemic anti-cancer therapy within 30 days of starting or completing study treatment
• Patients must have normal organ and marrow function as defined in the protocol.
• Effects of Sunitinib on the developing human fetus at the recommended therapeutic dose are unknown. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Patients with leptomeningeal metastases documented by MRI or CSF evaluation
• Evidence of intratumoural or peritumoural hemorrhage deemed significant by the treating physician
• Patients with metastases within 5 mm of the optic chiasm or optic nerve
• Patients with metastases in the brainstem (midbrain, pons, or medulla).
• \< 4 weeks since any major surgery. (Previous brain surgery, including craniotomy for tumour resection \[except cerebral metastases\] or biopsy is permissible.)
• Prior resection of cerebral metastasis
• Previous cranial radiation. Patients may have had radiation therapy to other anatomical sites, but must have recovered from acute toxic effects prior to registration. At least 2 weeks must have elapsed since last dose of radiation before registration.
• Treatment with a non-approved or investigational drug concurrently or within 30 days before Day 0 of study treatment or within 30 days after the last day of study treatment.
• Treatment with sunitinib or other inhibitors of the VEGF signalling axis within 30 days before Day ) of study treatment or within 30 days after last day of study treatment.
• Bleeding disorders.
• Thrombolytic therapy within 4 weeks
• Concurrent use of anticoagulant or antiplatelet drugs
• Concurrent use of enzyme-inducing anti-epileptic drugs
• Patients with any condition that impairs their ability to swallow Sunitinib (e.g. gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease).
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Caroline Chung, MD

  University Health Network, Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2009
• First Posted: September 22, 2009
• Study Start: July 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2022
• Last Updated: October 7, 2022

Record last verified: 2022-10

Locations

CA (1)