Status:
COMPLETED
Vorinostat Combined With Isotretinoin and Chemotherapy in Treating Younger Patients With Embryonal Tumors of the Central Nervous System
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Medulloblastoma
Pineoblastoma
Eligibility:
All Genders
2-47 years
Phase:
PHASE1
Brief Summary
This pilot clinical trial studies the side effects and the best way to give vorinostat with isotretinoin and combination chemotherapy and to see how well they work in treating younger patients with em...
Detailed Description
PRIMARY OBJECTIVES: I. To investigate the feasibility of administering vorinostat (SAHA) and isotretinoin for three days prior and concomitant with cisplatin based chemotherapy over three courses of ...
Eligibility Criteria
Inclusion
- Patients must have a histologically confirmed, newly-diagnosed medulloblastoma (except for patients with the histology of localized (M0) desmoplastic medulloblastoma or atypical teratoid/rhabdoid tumor \[ATRT\]) or supratentorial primitive neuroectodermal tumor (PNET) including pineoblastomas
- Patients must have not received any prior therapy other than surgery and/or steroids
- Patient must have adequate pre-trial formalin-fixed, paraffin-embedded (FFPE) tumor material available for use in the biology studies and central pathology review; if snap frozen tissue is not available, the study chair must be contacted to discuss eligibility
- Patient must be a suitable candidate, by institutional standards for stem cell apheresis
- Lansky performance score (LPS for =\< 16 years of age) \>= 30 assessed within two weeks prior to registration
- Absolute neutrophil count (ANC) \>= 1000/ul (unsupported) (within 14 days of registration and within 7 days of the start of treatment)
- Platelets \>= 100,000/ul (unsupported) (within 14 days of registration and within 7 days of the start of treatment)
- Hemoglobin \>= 8 g/dL (may be supported) (within 14 days of registration and within 7 days of the start of treatment)
- Bilirubin \< 1.5 times upper limit of normal for age (within 14 days of registration and within 7 days of the start of treatment)
- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 1.5 times institutional upper limit of normal for age (within 14 days of registration and within 7 days of the start of treatment)
- Serum creatinine =\< 1.5 times upper limit of institutional normal for age or glomerular filtration rate (GFR) \>= 70 ml/min/1.73 m\^2 or estimated GFR (Schwartz bedside) that is \> 99 ml/min/1.73 m\^2 (within 14 days of registration and within 7 days of the start of treatment)
- Parents/legal guardians must have the ability to understand and the willingness to sign a written informed consent document according to institutional guidelines
Exclusion
- Patients with diagnosis of atypical teratoid/rhabdoid tumor (ATRT by histology, immunohistochemistry and/or molecular analysis) and desmoplastic M0 medulloblastoma will be excluded from the study
- Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that would compromise the patient's ability to tolerate protocol therapy or would interfere with the study procedures or results
- Patients receiving any other anticancer or investigational drug therapy are excluded
- Patients having taken valproic acid within 2 weeks prior to initiation of treatment are excluded
- Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy
- Patients with a parabens allergy
Key Trial Info
Start Date :
February 25 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2021
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00867178
Start Date
February 25 2009
End Date
December 22 2021
Last Update
January 13 2022
Active Locations (15)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States, 94304
3
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
4
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60611