Brain Tumors Clinical Trial
Official title:
NYU 05-40 PBMTC ONC-032P:High Dose Temozolomide,Thiotepa and Carboplatin With Autologous Stem Cell Rescue (ASCR) Followed by Continuation Therapy With 13-cis-retinoic Acid in Patients With Recurrent/Refractory Malignant Brain Tumors
Verified date | June 2021 |
Source | NYU Langone Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to: Find out how safe and effective (by monitoring the good and/or bad effects) treatment with high dose temozolomide, thiotepa and carboplatin with stem cell rescue followed by 13-cis-retinoic acid has on children and adolescents with recurrent/refractory brain tumors Find out how the body uses 13-cis-retinoic acid by studying the your blood levels and proteins in the blood that break down the 13-cis-retinoic acid Determine how well 13-cis-retinoic acid penetrates into the spinal fluid.
Status | Completed |
Enrollment | 46 |
Est. completion date | December 30, 2017 |
Est. primary completion date | June 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 21 Years |
Eligibility | Inclusion Criteria: 1. Patients with recurrent or refractory medulloblastoma/PNET, CNS germ cell tumors, ependymomas, AT/RT, high grade glioma and other malignant brain tumors. Brainstem gliomas are eligible if residual disease is < 1.5cc and if the patient is off decadron. 2. Patients must have recurrent or refractory disease following at least one prior course of therapy and must have minimal residual disease defined as < 1.5 cm2 of enhancement. Patients with + CSF cytology, linear or fine nodular leptomeningeal disease are eligible. 3. Adequate hematologic, renal, liver, and cardiac function as demonstrated by laboratory values performed within 21 days, inclusive, prior to administration of temozolomide. 4. Patients must have an adequate number of autologous stem cells available defined as a minimum of 2 x 106 CD 34+ cells/kg and preferably at least 5 x 106 CD 34+ cells/kg. Exclusion Criteria: 1. Previous myeloablative therapy 2. Frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction) 3. Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin. Patients with prior malignancies which have not required anti-tumor treatment within the preceding 24 months are eligible. |
Country | Name | City | State |
---|---|---|---|
Canada | Princess Margaret Hospital | Toronto | Ontario |
United States | Emory University | Atlanta | Georgia |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Medical Univ. of South Carolina | Charleston | South Carolina |
United States | Children's Memorial Hospital | Chicago | Illinois |
United States | Nationwide Children's Hospital | Columbus | Ohio |
United States | Children's Medical Center of Dallas | Dallas | Texas |
United States | MD Anderson Cancer Center (MDACC) | Houston | Texas |
United States | Riley Hospital for Children | Indianapolis | Indiana |
United States | Hawaii Pacific Health | Lihue | Hawaii |
United States | Children's Hospital and Clinics of Minnesota | Minneapolis | Minnesota |
United States | Vanderbilt Univ. | Nashville | Tennessee |
United States | Steven and Alexandra Cohen Children's Medical Center of New York- North Shore LIJ | New Hyde Park | New York |
United States | NYU Hassenfeld Center | New York | New York |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Phoenix Children's Hospital | Phoenix | Arizona |
United States | Virginia Commonwealth Univ. | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health | Children's Hospitals and Clinics of Minnesota, Schneider Children's Hospital |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event-free Survival (EFS) | EFS will be reported in patients with recurrent or refractory medulloblastoma/ primitive neuroectodermal tumors. EFS is defined as the length of time after primary treatment for a cancer ends that the patient remains free of certain complications or events that the treatment was intended to prevent or delay. | Day +42 | |
Primary | Overall Survival (OS) | OS will be reported in patients with recurrent or refractory medulloblastoma/ primitive neuroectodermal tumors. OS is defined as the length of time from the start of treatment that patients diagnosed with disease are still alive. | Day +77 | |
Secondary | Toxicity of of 13-cis-retinoic Acid | To report the toxicity of of 13-cis-retinoic acid following high dose temozolomide, thiotepa and carboplatin with ASCR. | One year |
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