131I-Omburtamab, in Recurrent Medulloblastoma and Ependymoma (NCT04743661) | Clinical Trial Compass
Active — Not RecruitingPhase 2
131I-Omburtamab, in Recurrent Medulloblastoma and Ependymoma
United States62 participantsStarted 2022-04-04
Plain-language summary
A Phase 2 study investigating the addition of cRIT 131I-omburtamab to irinotecan, temozolomide, and bevacizumab for patients with recurrent medulloblastoma. A feasibility cohort is included to assess the feasibility of incorporating cRIT 131I-omburtamab for patients with recurrent ependymoma.
Direct intraventricular delivery of radiolabeled tumor-specific antibodies may aid in both the detection and treatment of recurrent disease for these highly specific pediatric patients with recurrent tumors.
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. Craniospinal irradiation, whole brain radiation, total body irradiation, or radiation to \>= 50% of pelvis or spine 24 weeks prior to study enrollment. Tumor designated as "measurable" for protocol purposes must not have received radiation within 12 weeks prior to study enrollment.
✓. Focal radiation to areas of symptomatic metastatic disease at least 14 days prior to study enrollment.
✓. Peripheral absolute neutrophil count (ANC) ≥ 1 x 10\^9/ L (must not have received G-CSF within 7 days prior to enrollment or pegfilgrastim within 14 days prior to enrollment)
✓. Platelet count ≥ 100 x 10\^9/ L (unsupported, defined as no platelet transfusion within 7 days prior to study enrollment)
✓. Serum creatinine based on age/gender. Patients that do not meet the criteria in Table 1 but have a 24 hour Creatinine Clearance or GFR (radioisotope or iothalamate) ≥ 70 mL/min/1.73 m\^2 are eligible.
✓. Urine protein should be screened by dipstick analysis. If protein ≥ 2+ on dipstick, then Urine Protein Creatinine (UPC) ratio should be calculated. If UPC ratio \> 0.5, 24-hour urine protein should be obtained, and the level should be \< 1000 mg/24 hours for patient enrollment.
✓. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
Exclusion criteria
✕. Known strong and moderate inducers or inhibitors of CYP3A4/5, including enzyme-inducing anti-convulsant drugs (EIACDs), grapefruit, echinacea, grapefruit hybrids, pummelos, starfruit, and Seville oranges
What they're measuring
1
2-year event free survival (EFS) in the Recurrent Medulloblastoma Cohort
Timeframe: 2 years
2
Percentage of Patients who met feasibility criteria in the Recurrent Ependymoma Cohort
✕. Substrates of CYP3A4/5 with a narrow therapeutic index
✕. Herbal preparations/medications (except for vitamins) including, but not limited to: St. John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, black cohosh and ginseng. Patients should stop using all herbal medications and dietary supplements at least 7 days prior to enrollment.
✕. Craniospinal irradiation, whole brain radiation, total body irradiation or radiation to \>= 50% of pelvis or spine 24 weeks prior to study enrollment. The tumor designated as "measurable" for protocol purposes must not have received radiation within 12 weeks prior to study enrollment.
✕. Focal radiation to areas of symptomatic metastatic disease 14 days prior to study enrollment.
✕. Peripheral absolute neutrophil count (ANC) ≥ 1 x 10\^9/ L (must not have received G-CSF within the 7 days prior to enrollment or pegfilgrastim within the 14 days prior to enrollment)
✕. Platelet count ≥ 100 x 10\^9/ L (unsupported, defined as no platelet transfusion within 7 days prior to study enrollment)