Pazopanib in Treating Patients With Recurrent Glioblastoma

NCT00459381 | Completed Phase 2 Results DMC

• 4 other identifiers: NCI-2012-02710NABTC-0602U01CA062399CDR0000538083
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 9

Brief Summary

This phase II trial is studying the side effects and how well pazopanib works in treating patients with recurrent glioblastoma. Pazopanib 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 Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Recurrent Adult Brain Tumor

Outcome Measures

Primary Outcomes (2)

• 6 Months Progression-free Survival

  Calculated from study registration till 6month time point. Progression defined by Macdonald criteria Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration

  6 months

• Number of Participants Discontinuing Treatment Due to Toxicity

  Use NCI Common toxicity Criteria Adverse Event Version 3.0 to grade toxicities. Any patient who received at least one dose of pazopanib was evaluable for toxicity. Calculated the number of participants who had an event that was related to pazopanib that caused the patient to stop treatment due to this event.

  2 years

Secondary Outcomes (5)

• Most Common Toxicities Experienced After at Least One Dose of Pazopanib

  Up to 2 years

• Overall Radiographic Response (ORR) Rate

  2 years

• Best Radiographic Response

  3 years

• Overall Survival

  From date of registration to date of death due to any cause, assessed up to 2 years

• Time to Progression or Progression Free Survival

  1 year

Study Arms (1)

Treatment (pazopanib hydrochloride)

EXPERIMENTAL

Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Other: laboratory biomarker analysis

Drug: pazopanib hydrochloride; Other: laboratory biomarker analysis

Interventions

pazopanib hydrochloride DRUG

Given orally

Also known as: GW786034B, Votrient

Treatment (pazopanib hydrochloride)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (pazopanib hydrochloride)

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed glioblastoma multiforme, including gliosarcoma
• Recurrent disease
• Must have unequivocal radiographic evidence of tumor progression by MRI, as defined by any of the following:
• % increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline
• Clear worsening of any evaluable disease
• Appearance of any new lesions or site
• Clear clinical worsening
• Must have failed prior radiotherapy that was completed ≥ 42 days ago
• Patients who received prior therapy that included interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease, rather than radiation necrosis, based on positron emission tomography (PET) scan, thallium scanning, magnetic resonance spectroscopy, or surgical documentation of disease
• Treatment for no more than 2 prior relapses allowed
• Relapse is defined as progression following initial therapy (i.e., radiotherapy with or without chemotherapy, if that was used as initial therapy; therefore no more than 3 prior therapies \[initial therapy and therapy for 2 relapses\] allowed)
• If the patient had a surgical resection for relapsed disease and no anticancer therapy was instituted for up to 12 weeks, and the patient undergoes another surgical resection, this is considered as 1 relapse
• For patients who had prior therapy for a low-grade glioma, the surgical diagnosis of a glioblastoma multiforme will be considered the first relapse
• Karnofsky performance status 60-100%
• Life expectancy \> 8 weeks

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (9)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

University of California San Francisco

San Francisco, California, 94115, United States

Location

National Cancer Institute Neuro-Oncology Branch

Bethesda, Maryland, 20814, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15232, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• Iwamoto FM, Lamborn KR, Robins HI, Mehta MP, Chang SM, Butowski NA, Deangelis LM, Abrey LE, Zhang WT, Prados MD, Fine HA. Phase II trial of pazopanib (GW786034), an oral multi-targeted angiogenesis inhibitor, for adults with recurrent glioblastoma (North American Brain Tumor Consortium Study 06-02). Neuro Oncol. 2010 Aug;12(8):855-61. doi: 10.1093/neuonc/noq025. Epub 2010 Mar 3.

  PMID: 20200024 DERIVED

MeSH Terms

Conditions

Glioblastoma; Gliosarcoma; Brain Neoplasms

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Mark Gilbert, MD
• Organization: Adult Brain Tumor Consortium (ABTC)

jfisher@jhmi.edu

410-955-8837

Study Officials

• Howard Fine, MD

  North American Brain Tumor Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2007
• First Posted: April 11, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 15, 2017
• Results First Posted: March 15, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)