Carboplatin and Bevacizumab for Recurrent Ependymoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by National Institutes of Health Clinical Center (CC)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ) Identifier:
First received: February 11, 2011
Last updated: November 14, 2015
Last verified: October 2015
The goal of this clinical research study is to learn if the combination of bevacizumab and carboplatin can help to control recurrent pendymoma. The safety of this drug combination will also be studied....

Condition Intervention Phase
Anaplastic Ependymoma
Drug: Carboplatin
Drug: Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Carboplatin and Bevacizumab for the Treatment of Recurrent Low-Grade and Anaplastic Supratentorial, Infratentorial and Spinal Cord Ependymoma in Adults: A Multi-Center Trial

Resource links provided by NLM:

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • progression-free survival (PFS) at one year [ Time Frame: one year after end of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: October 2015
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizubab may be continued at the descretion of the treating physician.
Drug: Carboplatin
Carboplatin will be given on day 1 of each cycle; the carboplatin dose should be calculated using the Calvert formula: Carboplatin dose (mg) = target AUC x (CrCl + 25; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician
Drug: Bevacizumab
Bevacizumab will be administered on days 1 and 15 of each cycle. Bevacizumab will be administered at a dose of 10 mg/kg; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician.

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Ages Eligible for Study:   18 Years to 99 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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/mm3, platelet count of > 100,000/mm3, 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 CT scan.

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 Investigator.

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 2.

For core or needle biopsy, a minimum of 7 days must have elapsed prior to registration Step 2.

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 must not have any 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 must not have active infection or serious intercurrent medical illness.

Patients must not be pregnant/breast feeding. Patients must not be pregnant because animal studies show that carboplatin and bevacizumab are teratogenic

Patients must not have any disease that will obscure toxicity or dangerously alter drug


Patients must not 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 on full-dose anticoagulants (e.g., warfarin or LMW heparin) must meet both of the following criteria to be eligible:

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 1.

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 must not have current active hepatic or biliary disease (with exception of patients with Gilbert s syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01295944

Contact: Christine M Bryla, R.N. (301) 451-7868

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
United States, Massachusetts
Harvard Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030-4096
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Mark R Gilbert, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ) Identifier: NCT01295944     History of Changes
Other Study ID Numbers: 160009, 16-C-0009
Study First Received: February 11, 2011
Last Updated: November 14, 2015
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Brain Tumor
Spinal Cord Tumor

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 30, 2015