AZD2171 in Treating Patients With Recurrent Glioblastoma Multiforme
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| ClinicalTrials.gov Identifier: NCT00305656 |
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Recruitment Status :
Completed
First Posted : March 22, 2006
Last Update Posted : August 22, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor | Drug: cediranib maleate | Phase 2 |
PRIMARY OBJECTIVE:
I. Determine the proportion of patients with recurrent glioblastoma multiforme (GM) who are alive and progression free 6 months after starting AZD2171 therapy.
SECONDARY OBJECTIVES:
I. Assess the biological effect of AZD2171 by using the following MRI techniques: dynamic contrast-enhanced imaging; arterial spin-labeling imaging; perfusion-weighted imaging; and diffusion- tensor imaging at serial time points.
II. Measure circulating endothelial and progenitor cells and plasma levels of tumstatin, (vascular endothelial growth factor (VEGF)-A and -D, sVEGF receptors, P1GF, platelet-derived growth factor (PDGF)-AA, PDGF-AB, PDGF-BB, Ang1, thrombospondin-1, and interleukin-8 as markers for response to antiangiogenic therapy in recurrent GM.
III. Correlate treatment outcomes with pre-AZD2171 tumor specimens with respect to microvascular density, basement membrane and pericyte coverage, and angiopoietin-1 and -2 expression to determine whether these immunohistochemical analyses can be predictive of the response to AZD2171.
IV. Measure polymorphisms of kdr/flk-1 gene and genetic analysis of HIF1-alpha, TP53, and endothelial nitric oxide synthase genes in the archival tumor specimens.
V. Determine the overall survival of patients with recurrent GM treated with AZD2171.
VI. Determine the radiographic response rate in patients with recurrent GM treated with AZD2171.
VII. Determine the safety of AZD2171 in this patient population.
OUTLINE: This is a multicenter study.
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 12 months.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 31 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Study of AZD2171 in Recurrent Glioblastoma |
| Study Start Date : | January 2006 |
| Actual Primary Completion Date : | April 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm I
Patients receive oral AZD2171 once daily on days 1-28.
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Drug: cediranib maleate
Given orally
Other Names:
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- Proportion of patients alive and progression-free at 6 months [ Time Frame: 6 months ]
- Radiographic response proportion [ Time Frame: Up to 12 months ]Will be described with 95% confidence limits.
- Overall survival [ Time Frame: Up to 12 months ]Will be described with 95% confidence limits.
- Toxicity proportion [ Time Frame: Up to 12 months ]Will be described with 95% confidence limits.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria:
- AST/ALT =< 2.5 times upper limit of normal
- Creatinine normal OR creatinine clearance >= 60 mL/min
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305656
| United States, Massachusetts | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Tracy Batchelor | Massachusetts General Hospital |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00305656 History of Changes |
| Obsolete Identifiers: | NCT00254943 |
| Other Study ID Numbers: |
NCI-2009-00127 05-254 N02CO12400 ( Other Grant/Funding Number: US NIH Grant/Contract Award Number ) CDR0000460079 ( Registry Identifier: PDQ (Physician Data Query) ) |
| First Posted: | March 22, 2006 Key Record Dates |
| Last Update Posted: | August 22, 2013 |
| Last Verified: | July 2013 |
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Glioblastoma Gliosarcoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Cediranib Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Protein Kinase Inhibitors |