Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Edward Ziga
Age
1–29
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Age: ≥ 1 year and ≤ 29 years
2. Relapse or progression of any central nervous system tumor initially diagnosed before the age of 21 years.
3. Total or subtotal resection of tumor mass, confirmed by assessment by the neurosurgeon and by postoperative MRI scan within 72 hours after surgery. The post-operative assessment should demonstrate residual tumor less than or equal to 2 cm\^3 as judged by surgeon or on MRI the tumor should only show linear contrast enhancement at the border of the resection cavity or nodule less than 2 cm\^3.
4. No radiotherapy and/or chemotherapy received for at least 1 month before first DC vaccination is to be administered.
5. No treatment with corticosteroids or salicylates for at least 1 week before first vaccination.
6. Life expectancy ≥ 3 months
7. Written consent by patient or parent(s) (if patient is \< 18 years) on an institutional review board (IRB)-approved informed consent form prior to any study-specific evaluation. Assent is required from children as per University of Miami (UM) IRB guidelines. Subject must be capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent.
8. Adequate organ function (to be measured at enrollment)
* Absolute neutrophil count (ANC) ≥750/L
* Lymphocytes ≥ 500/L
* Platelets ≥ 75,000/L
* Hemoglobin ≥ 9 g/dL
* Aspartate aminotransferase (AST)/Alanine transaminase (ALT) ≤ 2.5 X upper limit of normal (ULN); if liver metastases, ≤ 5 X ULN
* Serum Creatinine ≤ 1.5 X ULN
* Total Bilirubin ≤ 3 X ULN
* Albumin \> 2 g/dL
9. Subjects must agree to use adequate method of contraception or abstinence throughout and up to 4 weeks after the study treatment completion.
10. Karnofsky score ≥ 70 or Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.
You may not be if
1. Pregnancy.
2. Breast feeding females.
3. Any concomitant participation in other therapeutic trials.
4. Virus serology positive for HIV (testing is not required in the absence of clinical suspicion).
5. Documented immunodeficiency or autoimmune disease.
6. Other active malignancies.
7. Refusal to use adequate contraception for fertile patients (females and males) during the study and for 30 days after the last dose of study treatment.
8. Any serious or uncontrolled medical or psychiatric condition that in the opinion of the investigator makes the patient not able to participate in the study.
9. Application of gliadel wafers within the prior 4 months or a plan to place Gliadel wafers at the time of resection for tumor acquisition for study.
