Status:
COMPLETED
AZD2171 in Treating Patients With Recurrent Glioblastoma Multiforme
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 fo...
Detailed Description
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 OBJECTIVE...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00305656
Start Date
January 1 2006
Last Update
August 22 2013
Active Locations (1)
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1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114