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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborators: Children's Hospital Colorado; National Cancer Institute (NCI)

Criteria

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 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 Criteria:

• 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