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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT01326104
Eligibility Criteria:
Inclusion Criteria:
Screening:
* Age ≤ 30 years of age.
* Suspected first recurrence/progression of MB/PNET since completion of definitive focal +/- craniospinal irradiation. Disease progression prior to receiving definitive focal +/- craniospinal irradiation will not disqualify patients from enrollment if they have subsequently failed definitive radiotherapy and are at first recurrence/progression at time of enrollment. Patients who are unable to receive radiation therapy due to genetic disorders that put them at significant risk for radiation-induced secondary malignancies (i.e. Gorlin's syndrome or NF1 mutation) are eligible for enrollment at first disease recurrence/progression.
Re-MATCH Protocol:
* Patients must have histologically confirmed recurrent MB/PNET that is a first relapse/progression after completion of definitive radiotherapy +/- craniospinal irradiation. Patients with a first relapse/progression who are unable to receive radiation therapy due to genetic disorders that put them at significant risk for radiation-induced secondary malignancies (ie. Gorlin's syndrome or NF1 mutation) are eligible for enrollment.
* Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration.
* Karnofsky Performance Status of ≥ 50% or Lansky Performance Score of ≥ 50.
* Absolute Neutrophil Count (ANC) ≥ 1000/µl (unsupported).
* Platelets ≥ 100,000/µl (unsupported).
* Hemoglobin \> 8 g/dL (may be supported).
* Serum creatinine ≤ upper limit of institutional normal
* Bilirubin ≤ 1.5 times upper limit of normal for age.
* Serum Glutamic Oxaloacetic Transaminase (ALT) ≤ 3 times institutional upper limit of normal for age.
* Serum Glutamic Oxaloacetic Transaminase (AST) ≤ 3 times institutional upper limit of normal for age.
* Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study.
* Patient or patient guardian consent to peripheral blood stem cell (PBSC) and/or bone marrow harvest following registration if PBSC or bone marrow (CD34 count of at least 2x10\^6/kg) has not been previously stored and available for use.
* Signed informed consent according to institutional guidelines must be obtained prior to registration.
Exclusion Criteria:
* Pregnant or need to breast feed during the study period.
* Active infection requiring treatment or an unexplained febrile (\> 101.5F) illness.
* Known immunosuppressive disease, human immunodeficiency virus infection, or carriers of Hepatitis B or Hepatitis C virus.
* Patients with active renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), or pulmonary disease.
* Patients receiving concomitant immunosuppressive agents for medical condition.
* Patients who need definitive radiotherapy for treatment of recurrent MB/PNET. Focal boost radiotherapy may be delivered prior to immunotherapy if required for local control.
* Patients receiving any other concurrent anticancer or investigational drug therapy.
* Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction).
* Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
30 Years
Study:
NCT01326104
Study Brief:
Protocol Section:
NCT01326104