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|NCT01295944 : Carboplatin and Bevacizumab for Recurrent Ependymoma|
|Ages||Min: 18 Years Max: 99 Years|
- INCLUSION CRITERIA:
Histologically proven intra-cranial or spinal ependymoma or anaplastic ependymoma. There
must be pathologic or imaging confirmation of tumor progression or regrowth.
The patient must have at least 1 block of tissue or 15 unstained slides at a minimum
available for central pathology review and molecular profiling of the tissue sample.
All patients must sign an informed consent indicating that they are aware of the
investigational nature of this study. Patients must have signed an authorization for the
release of their protected health information.
Patients must be > 18 years old.
Patients must have a Karnofsky performance status of > 60.
Patients must have adequate bone marrow function (WBC > 3,000/microliter, ANC > 1,500/mm^3,
platelet count of > 100,000/mm^3, and hemoglobin > 10 gm/dl), adequate liver function (SGOT
[AST <92.5 Units/L] and bilirubin < 1.5 mg/dL), and adequate renal function (creatinine <
1.5 mg/dL and calculated creatinine clearance > 60 cc/min) before starting therapy.
Eligibility level for hemoglobin may be reached by transfusion.
Patients must have shown unequivocal radiographic evidence for tumor progression by MRI or
At the time of registration: Patients must have recovered from the toxic effects of prior
therapy: > 28 days from any investigational agent, >28 days from prior cytotoxic therapy,
>14 days from vincristine, >42 days from nitrosoureas, >21 days from procarbazine
administration, and >7 days for non-cytotoxic agents, e.g., interferon, tamoxifen,
thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count). Any questions
related to the definition of non-cytotoxic agents should be directed to the Principal
Patients having undergone recent resection of recurrent or progressive tumor will be
eligible as long as all of the following conditions apply:
They have recovered from the effects of surgery.
A minimum of 28 days have elapsed from the day of surgery to the day of registration Step
For core or needle biopsy, a minimum of 7 days must have elapsed prior to registration Step
Residual disease following resection of recurrent ependymoma is not mandated for
eligibility into the study. To best assess the extent of residual disease post-operatively,
a CT/ MRI should be done no later than 96 hours in the immediate post-operative period or
at least 4 weeks post-operatively, within 14 days prior to consent. If the within 96-hour
after surgery scan is more than 14 days before consent the scan needs to be repeated. If
the steroid dose is increased between the date of imaging and consent, a new baseline
MRI/CT is required on a stable steroid dosage for at least 5 days.
Patients must have failed prior radiation therapy* and must have an interval of greater
than or equal to 42 days from the completion of radiation therapy to study entry. Note:
Patients with an indication for craniospinal radiotherapy (i.e., extensive leptomeningeal
disease) but have refused palliative craniospinal radiotherapy are eligible.
Patients with prior therapy that included interstitial brachytherapy or stereotactic
radiosurgery must have confirmation of true progressive disease rather than radiation
necrosis based upon either PET or Thallium scanning, MR spectroscopy, or
surgical/pathological documentation of disease.
Women of childbearing potential must have a negative B-HCG pregnancy test documented within
14 days prior to registration.
Women of childbearing potential and male participants agree to practice adequate
Patients withany significant medical illnesses that in the investigator s opinion cannot be
adequately controlled with appropriate therapy or would compromise the patient s ability to
tolerate this therapy.
Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma
insitu of the cervix), unless in complete remission and off of all therapy for that disease
for a minimum of 3 years are ineligible.
Patients with an active infection or serious intercurrent medical illness.
Patients found to be pregnant/breast feeding. Patients must not be pregnant because animal
studies show that carboplatin and bevacizumab are teratogenic
Patients with any disease that will obscure toxicity or dangerously alter drug
Patients who have received prior therapy with bevacizumab, or related drugs (previous
therapy with carboplatin is allowed).
Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or
diastolic blood pressure > 100 mmHg) despite antihypertensive medication.
New York Heart Association (NYHA) Grade II or greater congestive heart failure.
9 History of myocardial infarction or unstable angina within 12 months prior to Day 1.
History of stroke or transient ischemic attack.
Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent
peripheral arterial thrombosis) within 6 months prior to Day 1.
History of hemoptysis (greater than or equal to 1/2 teaspoon of bright red blood per
episode) within 1 month prior to Day 1.
Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic
anticoagulation). (To be eligible, Prothrombin time/international normalized ratio (PT INR)
should be < 1.4 for patients not on warfarin.)
Patients receiving full-dose anticoagulants therapy (e.g., warfarin or LMW heparin) and
does not meet both of the following criteria:
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) on a stable dose of oral anticoagulant or on a
stable dose of low molecular weight heparin.
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior
to Day 1 of treatment or anticipation of need for major surgical procedure during the
course of the study.
Core biopsy or other minor surgical procedure, excluding placement of a vascular access
device, within 7 days prior to Day 1.
History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day
Serious, non-healing wound, active ulcer, or untreated bone fracture.
Proteinuria as demonstrated by a UPC ratio greater than or equal to 1.0 at screening, or
Urine dipstick for proteinuria greater than or equal to 2+ (patients discovered to have
greater than or equal to 2+ proteinuria on dipstick urinalysis at baseline should undergo a
24 hour urine collection and must demonstrate less than or equal to 1g of protein in 24
hours to be eligible).
Known hypersensitivity to any component of bevacizumab.
Patients has current active hepatic or biliary disease (with exception of patients with
Gilbert s syndrome, asymptomatic gallstones, or stable chronic liver disease per
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