Know Cancer

or
forgot password

A Phase II Multi-Institutional Trial of Focal Radiotherapy With Concomitant Carboplatin as a Radiosensitizer and the Prospective Analysis of Survivin, an Inhibitor of Apoptosis, as a Biomarker in Children With Newly Diagnosed Non-Metastatic Ependymoma and Minimal Residual Disease Post-Operatively


Phase 2
12 Months
21 Years
Open (Enrolling)
Both
Ependymoma

Thank you

Trial Information

A Phase II Multi-Institutional Trial of Focal Radiotherapy With Concomitant Carboplatin as a Radiosensitizer and the Prospective Analysis of Survivin, an Inhibitor of Apoptosis, as a Biomarker in Children With Newly Diagnosed Non-Metastatic Ependymoma and Minimal Residual Disease Post-Operatively


Inclusion Criteria:



- Patients must be enrolled before treatment begins.

- Patients must be ≥ 12 months and < 22 years of age at the time of diagnosis.

- The target tumors are primary brain non-metastatic (M0) ependymomas tumors.
Patients must have histologic verification of an ependymoma at diagnosis. Patients
with the following world health organization (WHO) diagnoses will be eligible for
this study:Ependymoma (Subtypes: cellular, papillary, clear cell and tanycytic)
and Anaplastic Ependymoma

- Life expectancy of ≥ 8 weeks.

- Newly diagnosed ependymoma and must not have had any prior chemotherapy or
radiotherapy.

- All patients must have:

- A pre-operative MRI scan of the brain with and without contrast. NOTE: CT scans
are NOT sufficient for study eligibility since radiation therapy planning and
responses will be based on MRI scans only.

- Post-operative head MRI scan with and without contrast (preferably within 72
hours post-operatively).

- Spinal MRI (T-1 weighted imaging with and without gadolinium) is required within
28 days of surgery if done post-operatively and within 14 days of surgery if
done pre-operatively. For posterior fossa tumors, pre-operative MRI scans are
preferred because surgically induced inflammation/blood can be difficult to
distinguish from tumor.

- Lumbar CSF cytology examination obtained between 7 and 31 days following
surgery.

- Adequate bone marrow function, defined as:

- Peripheral absolute neutrophil count (ANC) >1500/μL

- Platelet count ≥ 100,000/μL (transfusion independent)

- Hemoglobin ≥ 10.0 gm/dl (may receive RBC transfusions)

- Adequate renal function defined as:

- Serum creatinine < 1.5 times the upper limit of normal based on the patient's
age, or creatinine clearance greater than 60 ml/min/1.73 m² corrected for age
and body surface area.

- Adequate liver function defined as:

- Total bilirubin <1.5 x the institutional normal

- SGOT (AST) or SGPT (ALT) <2.5 x institutional normals.

- Patients must begin chemoradiotherapy within 56 days of definitive surgery.

- All patients and/or their parents or legal guardians must sign a written informed
consent

- Patients must provide assent as per local IRB guidelines (if applicable).

- Patients and/or their families must consent to the mandatory biology studies,
including serum Survivin levels, CSF Survivin levels, paraffin-embedded tissue and
fresh-frozen tissue when available.

- Karnofsky/Lansky scoring greater than 50.

- Corticosteroid supportive care is permissible at the clinician's discretion prior to
and during chemo-radiotherapy.

- Anti-seizure medication support is permitted as necessary and at the treating
physician's discretion.

Exclusion:

- Prior chemotherapy or prior radiotherapy

- Patients who are pregnant or breast feeding, or patients (male or female) not
employing adequate contraception. Acceptable means of birth control include IUD,
oral contraceptive, subdermal implant, a condom with a contraceptive sponge or
suppository or abstinence.

- Patients who are unable to undergo MR imaging

- Patients with evidence of metastatic disease on spine MRI or CSF sampling

- Patients with post-operative residual tumor > 0.5 cm, unless a repeat surgery is
performed making the residual tumor less than 1.5 cm². Note: Timing for enrollment
and initiation of therapy will begin after second surgery if a repeat surgery is
performed.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Measure the EFS of newly diagnosed non-metastatic ependymoma patients treated with a combination of daily carboplatin as a radiosensitizer and conformal radiotherapy.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Jason Fangusaro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ann & Robert H Lurie Children's Hospital of Chicago

Authority:

United States: Institutional Review Board

Study ID:

CMH 09C4

NCT ID:

NCT01088035

Start Date:

April 2010

Completion Date:

April 2015

Related Keywords:

  • Ependymoma
  • Childhood ependymoma
  • Ependymoma
  • Survivin
  • Ependymoma
  • Neoplasm, Residual

Name

Location

Children's Memorial HospitalChicago, Illinois  60614