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:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT00101205
Eligibility Criteria:
Inclusion Criteria:
* Life expectancy \> 8 weeks
* Albumin \> 2 g/dL
* Histologically confirmed diagnosis of 1 of the following: solid tumor; histologic verification not required for brainstem tumors or optic pathway tumors; lymphoma; recurrent or refractory to conventional therapy OR no known effective therapy exists; bone marrow involvement allowed
* Performance Status: Karnofsky \>= 50 % (patients \> 10 years of age) OR Lansky \>= 50% (patients for =\< 10 years of age)
* Absolute neutrophil count \> 1,000/mm\^3
* Platelet count \> 100,000/mm\^3 (transfusion independent)
* Hemoglobin \> 8 g/dL (transfusion allowed)
* ALT \< 5.0 times ULN
* Creatinine normal OR glomerular filtration rate \>= 80 mL/min/1.73 m\^2
* Calcium normal (electrolyte supplements allowed)
* Echocardiogram and EKG normal
* Shortening fraction \>= 27% OR ejection fraction \> 50%
* No evidence of dyspnea at rest
* No exercise intolerance
* Pulse oximetry \> 94% on room air
* Neurologic deficits due to CNS tumor must be relatively stable for \>= 2 weeks before study entry
* Seizure disorder allowed provided well-controlled by non-enzyme-inducing anticonvulsants
* No peripheral neurotoxicity \> grade 1
* Sodium, potassium, and magnesium normal (electrolyte supplements allowed)
* At least 1 week since prior biologic agents
* More than 1 week since prior growth factors
* More than 6 months since prior allogeneic peripheral blood stem cell transplantation AND no active graft-versus-host disease
* More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
* More than 2 weeks since prior focal radiotherapy for symptomatic metastatic sites
* More than 6 weeks since prior substantial bone marrow radiotherapy
* More than 3 months since prior craniospinal (\> 24 Gy), whole pelvis, or total-body radiotherapy
* Recovered from all prior therapy
* No concurrent enzyme-inducing anticonvulsants, including, but not limited to, the following: Barbiturates; Phenytoin; Carbamazepine
Exclusion Criteria:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No uncontrolled infection
* No history of life-threatening hypersensitivity to platinum-containing agents
* No prior oxaliplatin
* No other concurrent investigational agents
* No other concurrent anticancer therapy
* Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT00101205
Study Brief:
Protocol Section:
NCT00101205