Study of the Effect of GM-CSF on Macrophages in Ependymoma (NCT04408092) | Clinical Trial Compass
CompletedEarly Phase 1
Study of the Effect of GM-CSF on Macrophages in Ependymoma
United States6 participantsStarted 2013-06-25
Plain-language 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 immune cells and this study is looking at whether or not this will improve the outcome of patients with an ependymoma
Who can participate
Age range12 Months – 21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 …
What they're measuring
1
Number of participants with increased M/M infiltration compared to institutional and ACNS0121 controls