Clinical Trials

Text Size A A

E-Mail to a Friend






secret  Click to Play Audio


Brain/Spinal Cord Cancers

Radiation Therapy w/wo Cediranib Maleate for Newly Diagnosed Glioblastoma (7196)
Randomized, Phase II, Double-Blind, Placebo-Controlled Trial of Conventional Chemoradiation and Adjuvant Temozolomide Plus Cediranib Versus Conventional Chemoradiation and Adjuvant Temozolomide Plus Placebo in Patients with Newly Diagnosed Glioblastoma
Status Conditions Phase Study ID
Closed Brain and Central Nervous System Tumors Phase II 7196
NCT01062425
Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Cediranib maleate 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. It is not yet known whether temozolomide and radiation therapy are more effective when given with or without cediranib maleate in treating glioblastoma.

PURPOSE: This randomized phase II trial is studying temozolomide, radiation therapy, and cediranib maleate to see how well they work compared with temozolomide, radiation therapy, and a placebo in treating patients with newly diagnosed glioblastoma.


Investigator
George Laramore, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

 

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed glioblastoma or gliosarcoma (WHO grade IV)

    • Diagnosis must have been made by partial or complete surgical excision within the past 3-5 weeks

      • Cavitron ultrasonic aspirator-derived material or stereotactic biopsy not allowed
    • Tumor must have a supratentorial component
  • Must have ≥ 1 block of tumor tissue available for analysis of MGMT status

    • Tumor tissue must be of sufficient size for analysis of MGMT status, as determined by central pathology review
  • No recurrent or multifocal malignant gliomas
  • No metastases detected below the tentorium or beyond the cranial vault

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • ANC ≥ 1,800/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)
  • BUN ≤ 30 mg/dL
  • Creatinine ≤ 1.7 mg/dL
  • Urine protein:creatinine ratio ≤ 0.5 by urinalysis OR urine protein < 1,000 mg by 24-hour urine collection
  • Bilirubin ≤ 2.0 mg/dL
  • ALT and AST ≤ 3 times normal
  • PT/INR < 1.4 (unless on full-dose anticoagulation)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to undergo MRI or PET scan (i.e., no pacemaker or weight limitation) (for advanced imaging substudy)
  • Able to tolerate 2 IV lines, 1 in each arm (for advanced imaging substudy)
  • Systolic BP ≤ 150 mm Hg or diastolic BP ≤ 90 mm Hg within the past 14 days (in the presence or absence of a stable regimen of anti-hypertensive therapy)
  • Mean QTc ≤ 500 msec (with Bazett's correction) on screening EKG
  • No familial long QT syndrome or other significant ECG abnormality within the past 14 days
  • No severe, active co-morbidity including, but not limited to, any of the following:

    • Unstable angina and/or congestive heart failure requiring hospitalization
    • Transmural myocardial infarction within the past 6 months
    • Recent myocardial infarction or ischemia as evidenced by S-T elevations of ≥ 2 mm on EKG within the past 14 days
    • NYHA class II-IV congestive heart failure requiring hospitalization within the past 12 months
    • Stroke, cerebral vascular accident, or transient ischemic attack within the past 6 months
    • Serious and inadequately controlled cardiac arrhythmia
    • Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease
    • Evidence of bleeding diathesis or coagulopathy
    • Serious or non-healing wound, ulcer, or bone fracture
    • Abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or significant traumatic injury within the past 28 days
    • Acute bacterial or fungal infection requiring IV antibiotics
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

      • Laboratory tests for liver function and coagulation parameters not required
    • AIDS based upon current CDC definition

      • HIV testing not required
    • Active connective tissue disorders, such as lupus or scleroderma, that, in the opinion of the treating physician, may put the patient at high risk for radiation toxicity
    • Any other major medical illness or psychiatric impairment that, in the investigator's opinion, would prevent administration or completion of study therapy
  • No other invasive malignancy within the past 3 years except adequately treated nonmelanomatous skin cancer or curatively treated carcinoma in situ of the breast, oral cavity, or cervix
  • No prior allergic reaction to temozolomide
  • No prior allergic reactions attributed to compounds of similar chemical or biologic composition to cediranib maleate
  • No prior allergic reactions attributed to compounds of similar chemical or biological composition to gadolinium or [18F]FLT contrast agents (for advanced imaging substudy)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Must have recovered from prior surgery, post-operative infection, and other complications
  • More than 28 days since prior major surgical procedure or open biopsy (other than craniotomy for tumor resection)
  • More than 30 days since prior and no concurrent treatment on other therapeutic clinical trials
  • At least 14 days since prior and no concurrent enzyme-inducing anti-epileptic drugs (EIAEDs)

    • Concurrent non-EIAEDs allowed
  • No prior chemotherapy or radiosensitizers for cancer of the head and neck region

    • Prior chemotherapy for a different cancer allowed
  • No prior temozolomide or cediranib maleate
  • No prior Gliadel wafers or any other intratumoral or intracavitary treatment
  • No prior radiotherapy to the head or neck (except for T1 glottic cancer) resulting in overlap of radiotherapy fields
  • No other concurrent VEGF inhibitors
  • Concurrent full-dose anticoagulants (e.g., warfarin or low molecular weight heparin) allowed provided both of the following criteria are met:

    • No active bleeding or pathological condition that carries a high-risk of bleeding (e.g., tumor involving major vessels or known varices)
    • In-range INR (usually between 2 and 3) and patient is on a stable dose of oral anticoagulant or low molecular weight heparin
Last Updated
July 25, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.