Status:
COMPLETED
Study of the Effect of GM-CSF on Macrophages in Ependymoma
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Cancer Institute (NCI)
Children's Hospital Colorado
Conditions:
Ependymoma, Recurrent Childhood
Ependymoma
Eligibility:
All Genders
12-21 years
Phase:
EARLY_PHASE1
Brief Summary
This study plans to learn more about the use of Granulocyte Macrophage Colony Stimulation Factor (GM-CSF) on ependymoma tumors. The use of GM-CSF is a potential way of increasing the infiltration of i...
Detailed Description
To study whether Granulocyte Macrophage Colony Stimulation Factor (GM-CSF) increases macrophage infiltration in children with ependymoma (EPN) who are to have planned surgery as a standard procedure f...
Eligibility Criteria
Inclusion
- Age \> 12 months and \< 21 years at the time of study enrollment.
- Patients must be one of the following:
- • Newly diagnosed with posterior fossa ependymoma with a subtotal resection at initial surgery. These patients will be eligible for stratum 1.
- Be in first relapse of their posterior fossa ependymoma. These patients will be eligible for stratum 2.
- Histologically confirmed diagnosis of intracranial ependymoma .
- Pre or post-operative MR imaging of the brain demonstrates no evidence of non-contiguous spread beyond the primary site
- Pre or post-operative MR imaging of the spine demonstrates no evidence of non-contiguous spread beyond the primary site
- Pre-operative CSF cytology obtained from the lumbar CSF space demonstrated no evidence of non-contiguous spread beyond the primary site.
- • The requirement for lumbar CSF examination may be waived if deemed to be medically contraindicated.
- Patients must meet one of the following performance scores.
- • ECOG performance status scores of 0, 1, or 2.
- Karnofsky score of ≥ 50 for patients \> 16 years of age or Lansky score of ≥ 50 for patients ≤ 16 years of age
- Organ Function Requirements:
- Adequate renal function defined as:
- Creatinine clearance or radioisotope GFR ³ 70ml/min/1.73 m2 or
- A serum creatinine based on age/gender as follows:
- Age Maximum Serum Creatinine (mg/dL) Male Female
- 1 month to \< 6 months 0.4 0.4 6 months to \< 1 year 0.5 0.5
- 1 to \< 2 years 0.6 0.6 2 to \< 6 years 0.8 0.8 6 to \< 10 years 1 1 10 to \< 13 years 1.2 1.2 13 to \< 16 years 1.5 1.4
- ≥ 16 years 1.7 1.4 The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR (Schwartz et al. J. Peds, 106:522, 1985) utilizing child length and stature data published by the CDC.
- Adequate liver function defined as:
- Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age, and
- SGOT (AST) or SGPT (ALT) \< 3 x upper limit of normal (ULN) for age.
- Patients with Gilbert syndrome or hemolytic anemia are eligible if total bilirubin is \< 3 x upper limit of normal (ULN) for age.
- Adequate Bone Marrow Function defined as:
- Peripheral absolute neutrophil count (ANC) \>= 1,000/uL
- Platelet count \>= 100,000/uL (transfusion independent).
Exclusion
- Patients with a diagnosis of spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, supratentorial ependymoma, or mixed glioma are NOT eligible.
- Patients with evidence of metastatic disease by MRI or CSF cytology are NOT eligible
Key Trial Info
Start Date :
June 25 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04408092
Start Date
June 25 2013
End Date
July 21 2023
Last Update
March 15 2024
Active Locations (2)
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1
Children's Hospital Colorado
Denver, Colorado, United States, 80045
2
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806