Study of the Effect of GM-CSF on Macrophages in Ependymoma

Completed · Early Phase 1

Conditions studied: Ependymoma, Recurrent Childhood, Ependymoma

In brief

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 immune cells and this study is looking at whether or not this will improve the outcome of patients with an ependymoma

Key facts

Study ID

NCT04408092

Run by

University of Colorado, Denver

People needed

6

Starts

2013-06-25

Expected to finish

2023-07-21

Last updated by the study team

2024-03-15

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:

You may not qualify if…

• 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

Where it is running

• Children's Hospital Colorado — Denver, Colorado, United States
• Arnold Palmer Hospital for Children — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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