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Phase II Trial of Carboplatin and Bevacizumab for the Treatment of Recurrent Low-Grade and Anaplastic Supratentorial, Infratentorial and Spinal Cord Ependymoma in Adults


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Brain Tumor, Spinal Tumor, Glial Tumour of Brain, Ependymal Tumour of Brain, Spinal Cord Ependymoma, Anaplastic Ependymoma

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Trial Information

Phase II Trial of Carboplatin and Bevacizumab for the Treatment of Recurrent Low-Grade and Anaplastic Supratentorial, Infratentorial and Spinal Cord Ependymoma in Adults


The Study Drugs:

Carboplatin is designed to interfere with the growth of cancer cells by stopping cell
division, which may cause the cells to die.

Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the
growth of blood vessels.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive carboplatin by
vein over 30 minutes on Day 1 of each 28-day cycle. You will receive bevacizumab by vein
over 90 minutes on Days 1 and 15 of each cycle.

Study Visits:

Every week:

-Blood (about 1 - 2 teaspoons) will be drawn for routine tests.

Every 4 weeks:

- Urine will be collected to check your kidney function.

- You will be asked about any drugs you may be taking and if you have had any side
effects.

Every 8 weeks:

- Your medical history will be recorded.

- You will have a physical exam, including measurement of your vital signs.

- You will have a neurological exam.

- Your performance status will be recorded.

- You will complete the quality of life questionnaire.

- You will have an MRI scan or CT scan of the head and/or spine to check the -status of
the disease.

At any time during the study, extra tests may be performed if the doctor thinks they are
needed for your safety. The study doctor will tell you more about any extra tests.

Length of Study:

You will receive up to 6 cycles of the study drug combination. You will be taken off study
early if the disease gets worse or you experience intolerable side effects.

If the disease has not gotten worse after 6 cycles of receiving the study drug combination,
you will be able to continue receiving bevacizumab alone for as long as the doctor thinks it
is in your best interest. You will continue to follow the same study visit schedule
detailed above.

Long-Term Follow-up:

If you go off study because the disease got worse or you experienced intolerable side
effects, the study staff will call you every 3 months from then on to check your health.
Each phone call should take about 5 minutes.

This is an investigational study. Carboplatin is FDA approved and commercially available
for the treatment of advanced ovarian cancer. Bevacizumab is FDA approved and commercially
available for the treatment of glioblastoma multiforme (a type of brain tumor). The use of
these drugs in combination in ependymoma is investigational.

Up to 46 patients will take part in this study. Up to 25 patients will be enrolled at MD
Anderson.


Inclusion Criteria:



1. Histologically proven intra-cranial or spinal ependymoma or anaplastic ependymoma.
There must be pathologic or imaging confirmation of tumor progression or regrowth.
The patient's histologic diagnosis must be confirmed on Central Pathology Review
prior to registration Step 2. * If a patient has already had central pathology review
at MDACC (for example, from a previous enrollment to protocol CERN08-02), the central
pathology does not need to be repeated. Previous pathology confirmation can be
utilized for this study's pathology eligibility testing.

2. 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.

3. 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 registered in the
MDACC OMCR database prior to treatment with study drug.

4. Patients must be >/= 18 years old.

5. Patients must have a Karnofsky performance status of >/= 60.

6. Patients must have adequate bone marrow function (WBC >/= 3,000/┬Ál, 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 renal function (creatinine < 1.5 mg/dL and calculated creatinine clearance >/= 60
cc/min) before starting therapy. These tests must be performed within 14 days prior
to registration. Eligibility level for hemoglobin may be reached by transfusion.

7. Patients must have shown unequivocal radiographic evidence for tumor progression by
MRI or CT scan. If an MRI is being obtained to verify eligibility, it is recommended
that the MRI parameters follow the specifications detailed in the protocol so that
the patient will not require a repeat MRI prior to treatment start.

8. 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 Study Chair.

9. Patients having undergone recent resection of recurrent or progressive tumor will be
eligible with the following conditions apply: a) They have recovered from the effects
of surgery. b) 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. c) 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 registration. If the within 96-hour after
surgery scan is more than 14 days before registration, the scan needs to be repeated.
If the steroid dose is increased between the date of imaging and registration, a new
baseline MRI/CT is required on a stable steroid dosage for at least 5 days.

10. 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.

11. 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.

12. Women of childbearing potential must have a negative B-HCG pregnancy test documented
within 14 days prior to registration.

13. Women of childbearing potential and male participants agree to practice adequate
contraception.

Exclusion Criteria:

1. 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.

2. Patients with a history of any other cancer (except non-melanoma skin cancer or
carcinoma in-situ of the cervix), unless in complete remission and off of all therapy
for that disease for a minimum of 3 years are ineligible.

3. Patients must not have active infection or serious intercurrent medical illness.

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

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

6. Patients must not have received prior therapy with bevacizumab, or other agents known
to target the Vascular Endothelial Growth Factor (VEGF) pathway including sorafenib,
sunitinib, or cediranib.

7. Inadequately controlled hypertension (defined as systolic blood pressure >140 mmHg
and/or diastolic blood pressure > 90 mmHg) despite antihypertensive medication.

8. 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.

10. History of stroke or transient ischemic attack.

11. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or
recent peripheral arterial thrombosis) within 6 months prior to Day 1.

12. History of hemoptysis (>/= 1/2 teaspoon of bright red blood per episode) within 1
month prior to Day 1.

13. 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: a) No active bleeding or pathological condition
that carries a high risk of bleeding (e.g., tumor involving major vessels or known
varices); b) 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.

14. 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.

15. Core biopsy or other minor surgical procedure, excluding placement of a vascular
access device, within 7 days prior to Day 1.

16. History of abdominal fistula or gastrointestinal perforation within 6 months prior to
Day 1.

17. Serious, non-healing wound, active ulcer, or untreated bone fracture.

18. Proteinuria as demonstrated by a UPC ratio >/= 1.0 at screening, or Urine dipstick
for proteinuria >/= 2+ (patients discovered to have >/= 2+ proteinuria on dipstick
urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate

19. Known hypersensitivity to any component of bevacizumab.

20. 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).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with Progression-Free Survival at 1 Year

Outcome Description:

Progression-Free Survival (PFS) defined as length of time during and after treatment in which a patient is living with a disease that does not get worse.

Outcome Time Frame:

1 year following treatment

Safety Issue:

No

Principal Investigator

Mark R. Gilbert, MD,BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CERN09-02

NCT ID:

NCT01295944

Start Date:

March 2011

Completion Date:

Related Keywords:

  • Brain Tumor
  • Spinal Tumor
  • Glial Tumour of Brain
  • Ependymal Tumour of Brain
  • Spinal Cord Ependymoma
  • Anaplastic Ependymoma
  • Recurrent Ependymoma
  • Spinal cord ependymoma
  • Anaplastic ependymoma
  • Brain tumor
  • Spinal cord tumor
  • Carboplatin
  • Paraplatin
  • cancer
  • Brain Neoplasms
  • Ependymoma
  • Glioma
  • Spinal Cord Neoplasms
  • Spinal Neoplasms

Name

Location

Memorial Sloan Kettering Cancer Center New York, New York  10021
Massachusetts General Hospital Boston, Massachusetts  02114-2617
UT MD Anderson Cancer Center Houston, Texas  77030