Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT00079404
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed diagnosis of solid tumor or leukemia with documented M3 marrow
* Histologic confirmation of intrinsic brain stem tumors not required
* Relapsed or refractory disease
* No known curative therapy
* In patients with CNS tumors, neurologic deficits must be stable for at least the past week
* Performance status - Karnofsky 50-100% (\>10 years of age)
* Performance status - Lansky 50-100% (≤ 10 years of age)
* For patients with solid tumors:
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3 (transfusion independent)
* Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions)
* For patients with leukemia:
* Platelet count ≥ 20,000/mm\^3 (may receive platelet transfusions)
* Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions)
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT ≤ 2.5 times ULN
* Albumin ≥ 2 g/dL
* Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min
* Creatinine based on age as follows:
* ≤ 0.8 mg/dL if ≤ 5 years of age
* ≤ 1.0 mg/dL if \> 5 years and ≤ 10 years of age
* ≤ 1.2 mg/dL if \> 10 years and ≤ 15 years of age
* ≤ 1.5 mg/dL if \> 15 years and ≤ 21 years of age
* No uncontrolled infection
* No prior severe allergy to eggs
* No situation that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* At least 7 days (or window for adverse effects has passed) since prior biologic therapy and recovered
* At least 7 days since prior hematopoietic growth factors
* At least 2 months since prior stem cell transplantation and no evidence of graft-vs-host disease
* No concurrent hematopoietic growth factors
* No concurrent biologic therapy
* No concurrent immunotherapy
* At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered
* No other concurrent chemotherapy
* No concurrent steroid therapy
* At least 2 weeks since prior local palliative radiotherapy (small port)
* At least 3 months since prior total body irradiation or craniospinal radiotherapy
* At least 3 months since prior radiotherapy to ≥ 50% of the pelvis
* At least 6 weeks since prior substantial bone marrow radiotherapy
* Recovered from prior radiotherapy
* No concurrent radiotherapy
* No other concurrent investigational drugs
* No other concurrent anticancer agents
* No concurrent phenytoin or phenobarbital
* No concurrent warfarin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
21 Years
Study:
NCT00079404
Study Brief:
Protocol Section:
NCT00079404