Carboplatin as a Radiosensitizer in Treating Childhood Ependymoma
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|ClinicalTrials.gov Identifier: NCT01088035|
Recruitment Status : Terminated (Poor accrual)
First Posted : March 17, 2010
Last Update Posted : March 2, 2015
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|Condition or disease||Intervention/treatment||Phase|
|Ependymoma||Drug: Carboplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||April 2015|
Patients will receive daily carboplatin as a radiation sensitizer prior to radiation each day.
- Measure the EFS of newly diagnosed non-metastatic ependymoma patients treated with a combination of daily carboplatin as a radiosensitizer and conformal radiotherapy. [ Time Frame: 3 years ]
- Explore the tolerability, feasibility and toxicities associated with daily carboplatin as a radiosensitizer in patients with newly diagnosed non-metastatic ependymoma receiving focal fractionated radiotherapy. [ Time Frame: 1 year ]Tolerability and toxicity will be measured by documenting the toxicities associated with this treatment using the current CTCAE version 4.0. The feasibility of this therapy will be measured by observing the ability to finish therapy without delays and the ability to receive daily carboplatin and radiation in the time alloted by the study (within 4 hours) on a daily basis. Delays in therapy will be documented in an effort to define both tolerability and feasibility.
- Explore the overall survival (OS) in patients with newly diagnosed non-metastatic ependymoma treated with this regimen. [ Time Frame: 3 years ]
- Evaluate the feasibility of quantifying Survivin expression in primary ependymoma tumor, blood and CSF samples in a prospective fashion. [ Time Frame: 6 months ]
- Explore trends or relationships between Survivin expression (in tumor, blood and CSF samples) and tumor histology. [ Time Frame: 3 years ]
- Explore trends or relationships between Survivin expression (in tumor, blood and CSF samples) and patient responses. [ Time Frame: 3 years ]
- Explore trends or relationships between Survivin expression (in tumor, blood and CSF samples) and survival outcomes. [ Time Frame: 3 years ]
- Explore trends or relationships between Survivin expression (in tumor, blood and CSF samples) tumor recurrences. [ Time Frame: 3 years ]
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|Ages Eligible for Study:||12 Months to 21 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01088035
|United States, Illinois|
|Children's Memorial Hospital|
|Chicago, Illinois, United States, 60614|
|Principal Investigator:||Jason Fangusaro, MD||Ann & Robert H Lurie Children's Hospital of Chicago|
|Principal Investigator:||Rachel Altura, MD||Brown University|
|Responsible Party:||Jason Fangusaro, Attending, Ann & Robert H Lurie Children's Hospital of Chicago|
|Other Study ID Numbers:||
|First Posted:||March 17, 2010 Key Record Dates|
|Last Update Posted:||March 2, 2015|
|Last Verified:||February 2015|
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