AZD2171 in Treating Patients With Recurrent Glioblastoma Multiforme

NCT00305656 | Completed Phase 2 DMC

• 4 other identifiers: NCI-2009-0012705-254N02CO12400CDR0000460079
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well AZD2171 works in treating patients with recurrent glioblastoma multiforme. AZD2171 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 (1)

• Proportion of patients alive and progression-free at 6 months

  6 months

Secondary Outcomes (3)

• Radiographic response proportion

  Up to 12 months

• Overall survival

  Up to 12 months

• Toxicity proportion

  Up to 12 months

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive oral AZD2171 once daily on days 1-28.

Drug: cediranib maleate

Interventions

cediranib maleate DRUG

Given orally

Also known as: AZD2171, Recentin

Arm I

Eligibility Criteria

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

Criteria: * AST/ALT =\< 2.5 times upper limit of normal * Creatinine normal OR creatinine clearance \>= 60 mL/min * Measurable contrast-enhancing tumor \>= 1 cm in longest diameter by baseline MRI or CT scan: * Patient must have been on no steroids OR a stable dose of steroids for \>= 5 days prior to baseline MRI or CT scan * Patients who are on steroids must be maintained on a stable corticosteroid regimen from baseline scan until the start of study treatment * No intratumoral or peritumoral hemorrhage by MRI * Karnofsky performance status \>= 60% * No other concurrent malignancy within the past 5 years except curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast * Mini-mental status examination score \>= 15 * Histologically confirmed glioblastoma multiforme * Platelet count \>= 100,000/mm3 * Hemoglobin \>= 8 g/dL * Bilirubin normal * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD2171 * Mean QTc =\< 470 msec (with Bazett's correction) on screening electrocardiogram * No history of familial long QT syndrome * No greater than +1 proteinuria on 2 consecutive dipsticks taken \>= 1 week apart unless first urinalysis shows no protein * No uncontrolled intercurrent illness, including, but not limited to, any of the following: Hypertension; Ongoing or active infection; Symptomatic congestive heart failure; Unstable angina pectoris; Cardiac arrhythmia; Psychiatric illness/social situations that would limit compliance with study requirements * No known coagulopathy that increases the risk of bleeding * No history of clinically significant hemorrhages * Recovered from toxicity of prior therapy * At least 3 months since prior radiation therapy, including cranial radiation therapy * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) * At least 3 weeks since prior molecularly-targeted agents * At least 4 weeks since prior major surgery * No more than 2 prior chemotherapy regimens or antineoplastic drugs * More than 30 days since prior participation in an investigational trial * At least 2 weeks since prior enzyme-inducing antiepileptic drugs (EIAEDs) * No concurrent EIAEDs; Concurrent non-EIAEDs allowed * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent investigational agents * No concurrent vascular endothelial growth factor inhibitors: Prior thalidomide or lenolidomide allowed * No concurrent anticoagulants (e.g., warfarin) or antiplatelet agents including aspirin * No other concurrent anticancer agents or therapies * No concurrent grapefruit juice * WBC \>= 3,000/mm3 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Absolute neutrophil count \>= 1,500/mm3

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• Batchelor TT, Duda DG, di Tomaso E, Ancukiewicz M, Plotkin SR, Gerstner E, Eichler AF, Drappatz J, Hochberg FH, Benner T, Louis DN, Cohen KS, Chea H, Exarhopoulos A, Loeffler JS, Moses MA, Ivy P, Sorensen AG, Wen PY, Jain RK. Phase II study of cediranib, an oral pan-vascular endothelial growth factor receptor tyrosine kinase inhibitor, in patients with recurrent glioblastoma. J Clin Oncol. 2010 Jun 10;28(17):2817-23. doi: 10.1200/JCO.2009.26.3988. Epub 2010 May 10.

  PMID: 20458050 RESULT

• Emblem KE, Farrar CT, Gerstner ER, Batchelor TT, Borra RJ, Rosen BR, Sorensen AG, Jain RK. Vessel caliber--a potential MRI biomarker of tumour response in clinical trials. Nat Rev Clin Oncol. 2014 Oct;11(10):566-84. doi: 10.1038/nrclinonc.2014.126. Epub 2014 Aug 12.

  PMID: 25113840 DERIVED

MeSH Terms

Conditions

Glioblastoma; Gliosarcoma; Brain Neoplasms

Interventions

cediranib

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

Study Officials

• Tracy Batchelor

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

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: March 21, 2006
• First Posted: March 22, 2006
• Study Start: January 1, 2006
• Primary Completion: April 1, 2012
• Last Updated: August 22, 2013

Record last verified: 2013-07

Locations

US (1)