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Status:

COMPLETED

Cediranib, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Adult Giant Cell Glioblastoma

Adult Glioblastoma

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief Summary

This phase I/II trial is studying the side effects and best dose of cediranib to see how well it works when given together with temozolomide and radiation therapy in treating patients with newly diagn...

Detailed Description

PRIMARY OBJECTIVES: I. To determine the safety profile and optimal dose of AZD2171 (cediranib) (15mg or 20mg or 30mg) in combination with temozolomide and radiation in patients with newly diagnosed g...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Histologically confirmed glioblastoma
  • Newly diagnosed disease
  • Scheduled to receive standard post-surgical (i.e., biopsy or resection) temozolomide and radiotherapy
  • Must have residual, contrast-enhancing tumor (≥ 1 centimeter in ≥ 1 dimension)
  • Patients must be maintained on a stable corticosteroid regimen for 5 days prior to their baseline scan and for 5 days prior to their first vascular MRI; the dose of steroids should remain the same during the baseline vascular MRIs
  • Archival tumor tissue available for molecular analysis
  • No intratumoral hemorrhage or peritumoral hemorrhage by MRI
  • Karnofsky performance status 60-100%
  • Leukocytes ≥ 3,000/mcl
  • Absolute neutrophil count ≥ 1,500/mcL
  • Platelet count ≥ 100,000/mcL
  • Hemoglobin ≥ 8 g/dL
  • Total bilirubin normal
  • AST/ALT ≤ 2.5 times upper limit of normal
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Proteinuria ≤ 1+ on two consecutive dipsticks ≥ 7 days apart
  • Mini-mental status examination score ≥ 15
  • Must be able to tolerate MRI and must consent to participate in additional Vascular Imaging Procedures per protocol
  • CT scans cannot be substituted for MRI
  • Mean QTc ≤ 500 msec (with Bazett's correction) by electrocardiogram
  • No concurrent malignancy except curatively treated basal cell or squamous cell carcinoma skin cancer or carcinoma in situ of the cervix or breast
  • Patients with prior malignancies must be disease-free for ≥ 5 years
  • No history of familial long QT syndrome or other significant ECG abnormality
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to cediranib
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:
  • Hypertension (e.g., blood pressure \> 140/90 mm Hg)
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness/social situations that would preclude study compliance
  • No known coagulopathy that increases risk of bleeding
  • No history of clinically significant hemorrhages in the past
  • No New York Heart Association class III-IV heart disease
  • No condition requiring concurrent drugs or biologics with proarrhythmic potential
  • No other concurrent chemotherapy agents, investigational agents, or biologic therapy
  • No prior chemotherapy, radiotherapy, or any experimental therapy for this disease
  • No prior IV bevacizumab for any other medical condition
  • No prior carmustine implant (Gliadel Wafer)
  • No prior brachytherapy or radiosurgery for this disease
  • More than 30 days since prior and no other concurrent investigational agents or participation in an investigational therapeutic trial
  • At least 2 weeks since prior and no concurrent enzyme-inducing anti-epileptic drugs (EIAEDs)
  • Concurrent non-EIAEDs allowed
  • No concurrent CYP450-inducing anticonvulsants
  • No concurrent anticoagulants (e.g., dalteparin, warfarin, or low-molecular weight heparin)
  • If patients require warfarin or other anticoagulants (e.g., low-molecular weight heparin) while on study, then patient may continue treatment
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent VEGF inhibitors
  • No concurrent pentamidine
  • No concurrent herbal or nontraditional medications

Exclusion

    Key Trial Info

    Start Date :

    April 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 1 2014

    Estimated Enrollment :

    46 Patients enrolled

    Trial Details

    Trial ID

    NCT00662506

    Start Date

    April 1 2008

    End Date

    April 1 2014

    Last Update

    June 6 2023

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, United States, 02114

    2

    Dana-Farber Cancer Institute

    Boston, Massachusetts, United States, 02215