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 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT03615404
Eligibility Criteria:
Inclusion Criteria:
1. Age requirements:
1. ≤ 35 years for patients with grade IV glioma or recurrent World Health Organization (WHO) grade IV glioma
2. 3-35 years old for patients with recurrent medulloblastoma
2. Newly diagnosed or recurrent WHO grade IV glioma, recurrent WHO grade III glioma, or recurrent medulloblastoma (multifocal/disseminated disease is eligible, at the discretion of the PI)
3. Patients with WHO grade IV glioma who received surgery and radiation are eligible even without recurrence or progression
4. Patients must have recovered from all previous treatments including chemotherapy, radiation therapy, surgery, and other immunotherapies, etc.
a. If the patient was receiving bevacizumab at the time of enrollment, the treating oncologist has the discretion of administering and adjusting bevacizumab 10 mg/kg every 14 days. The rationale for continuing patients on bevacizumab is to prevent rebound cerebral edema commonly seen after stopping this agent.
5. Laboratory Studies:
1. Platelets ≥ 100,000 cells/mm3
2. Creatinine ≤ 1.2 x upper limit of normal (ULN)
3. Total bilirubin, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), alkaline phosphatase ≤ 2.5 x ULN
4. Neutrophil count ≥ 1000 cells/mm3
5. Hemoglobin ≥ 9 g/dl prior to biopsy (can be transfused)
6. Able to undergo brain MRI with and without contrast
7. Karnofsky Performance Status (KPS) ≥ 70 or Lansky Performance Status (LPS) ≥ 70
8. A signed informed consent form approved by the Institutional Review Board (IRB) will be required for patient enrollment into the study. Patients (if 18 years old or older) or their parent(s) or guardian(s) (if younger than 18 years old) must be able to read and understand the informed consent document and must sign the informed consent indicating that they are aware of the investigational nature of this study.
9. For females of childbearing potential, negative serum pregnancy test within 48 hours of leukapheresis
10. Females of childbearing potential must be willing to use acceptable contraceptive method to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug
11. Males with female partners of childbearing potential must agree to practice adequate contraceptive methods throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug
12. Newly diagnosed WHO grade IV glioma patients only: must be expected to complete standard of care radiation (minimum \~54 Gray)
Exclusion Criteria:
1. Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible)
2. Disease outside of the central nervous system (CNS)
3. Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C seropositive
4. Known active infection requiring intravenous (IV) antibiotics or active immunosuppressive disease
5. Severe, active co-morbidity, defined as follows:
1. Unstable angina and/or congestive heart failure requiring hospitalization
2. Transmural myocardial infarction within the last 6 months
3. Acute bacterial or fungal infection requiring intravenous antibiotics at initiation of Radiation Therapy (XRT)/Temozolomide (TMZ)
4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at initiation of XRT/TMZ for newly diagnosed patients or at initiation of dose-intensified (DI) TMZ for recurrent patients
5. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
6. Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive
7. Patients with autoimmune disease requiring medical management with immunosuppressant(s)
8. Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy
9. Active connective tissue disorders such as lupus or scleroderma that, in the investigator's opinion, place the patient at high risk for radiation toxicity
6. Pregnant or lactating women
7. Prior allergy to TMZ, GM-CSF, gadolinium (Gd), or Td
8. Prior history of brachial neuritis or Guillain-Barré syndrome
9. Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry
10. Patients receiving \> 0.1mg/kg or 4mg/day dexamethasone or equivalent
10\. For recurrent patients only: Patients who have not recovered from the toxic effects of prior chemo- and/or radiation therapy. Guidelines for this recovery period are dependent upon the specific therapeutic agent being used:
1. Patients who have received chemotherapy or bevacizumab ≤ 4 weeks \[except for nitrosourea (6 weeks) or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week)\] prior to starting the study drug unless patients have recovered from the side effects of such therapy. If the patient was receiving bevacizumab at the time of enrollment, the treating oncologist has the discretion of administering and adjusting bevacizumab 10 mg/kg every 14 days.
2. Patients who have received immunotherapy ≤ 4 weeks prior to starting the study drug unless patients have recovered from the side effects of such therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
35 Years
Study:
NCT03615404
Study Brief:
Protocol Section:
NCT03615404