Sunitinib in Treating Patients With Recurrent Malignant Gliomas

NCT00499473 | Completed Phase 2 Results

• 10 other identifiers: NCI-2009-00215OSU-IRB-2006C0098CDR0000554443OSU-06060OSU 060607745N01CM62207N01CM62203P30CA016058N01CM62206
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well sunitinib works in treating patients with recurrent malignant gliomas. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Conditions

Adult Anaplastic Astrocytoma; Adult Diffuse Astrocytoma; Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Adult Mixed Glioma; Adult Oligodendroglioma; Adult Pineal Gland Astrocytoma

Outcome Measures

Primary Outcomes (3)

• Progression-free Survival at 6 Months (Stratum 1)

  Number of patients with Progression-free Survival at 6 months for Stratum 1

  From time to registration to up to 6 months

• Maximum Tolerable Dose Based on Dose-limiting Toxicity of Sunitinib in Patients Receiving EIAC (Stratum 2)

  Maximum tolerable dose of sunitinib in patients receiving treatment with EIAC agents using dose escalation based on the steady-state trough sunitinib + SU12662 plasma concentrations on day 14 observed in patients treated in stratum 1. Six patients will be treated in each dose cohort with up to 12 patients being treated at the maximum tolerable dose for a total of 18-24 patients with gliomas receiving EIAC.

  From the time of first treatment with sunitinib until completion of treatment, assessed up to 30 days

• Dose Resulting in Steady-state Trough

  Average of pre-dose values of sunitinib + SU12662 plasma concentrations equivalent to that observed in patients not receiving EIAC based on pharmacokinetic modeling.

  At baseline (day 8) and days 15, 22, and 23

Secondary Outcomes (3)

• Confirmed Objective Response (Complete Response[CR] or Partial Response [PR])

  up to 12 weeks

• Percentage of Patients Progression Free at 12 Months

  At 12 months after the start of treatment

• Overall Survival

  up to 12 months

Study Arms (2)

Stratum 1 (kinase inhibitor therapy)

EXPERIMENTAL

Non-EIAC patients receive oral sunitinib malate once daily for 4 consecutive weeks followed by 2 weeks of rest.

Drug: sunitinib malate; Other: pharmacological study

Stratum 2 (kinase inhibitor therapy)

EXPERIMENTAL

EIAC \& OSU patients receive oral sunitinib malate as in stratum 1. Patients receive escalating doses of oral sunitinib malate until the maximum tolerated dose (MTD) is determined.

Drug: sunitinib malate; Other: pharmacological study

Interventions

sunitinib malate DRUG

Given orally

Also known as: SU11248, sunitinib, Sutent

Stratum 1 (kinase inhibitor therapy); Stratum 2 (kinase inhibitor therapy)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Stratum 1 (kinase inhibitor therapy); Stratum 2 (kinase inhibitor therapy)

Eligibility Criteria

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

You may qualify if:

• Stratum 1:
• Currently not receiving an enzyme-inducing anticonvulsant
• Patients receiving non-enzyme inducing anticonvulsants are eligible for this stratum
• Histologically confirmed WHO grade IV astrocytoma (glioblastoma multiforme \[GBM\]) including gliosarcoma
• Stratum 2 (USA patients only):
• Currently on stable dose of an enzyme-inducing anticonvulsant (with confirmed therapeutic serum levels) for at least 2 weeks prior to study registration including any of the following:
• Phenytoin
• Carbamazepine
• Phenobarbital
• Histologically confirmed grade IV astrocytoma (GBM), gliosarcoma, grade III astrocytoma, oligodendroglioma, or mixed oligoastrocytoma
• All patients must have unequivocal evidence of tumor progression by MRI or CT scan performed no longer than 14 days prior to study registration
• Patients undergoing surgery for progressive disease with nonmeasurable disease on post-operative MRI, ideally obtained within 48 hours of surgery, (i.e., macroscopic gross total resection) are eligible
• ECOG performance status 0-2 (Karnofsky ≥ 60%)
• Life expectancy \> 3 months
• Leukocytes ≥ 3,000/μL

You may not qualify if:

• History of allergic reactions attributed to compounds of similar chemical or biological composition to sunitinib malate
• Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or radiation therapy within 12 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• At least 4 weeks must have elapsed since any major surgery

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Astrocytoma; Glioblastoma; Gliosarcoma; Glioma; Oligodendroglioma

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Robert Cavaliere, MD
• Organization: The Ohio State University Comprehensive Cancer Center

Robert.Cavaliere@osumc.edu

614-293-4968

Study Officials

• Robert Cavaliere

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 11, 2007
• Study Start: June 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: October 1, 2014
• Last Updated: February 29, 2016
• Results First Posted: February 29, 2016

Record last verified: 2016-01

Locations

US (1)