Vorinostat and Bortezomib in Treating Young Patients With Refractory or Recurrent Solid Tumors, I… (NCT00994500) | Clinical Trial Compass
CompletedPhase 1
Vorinostat and Bortezomib in Treating Young Patients With Refractory or Recurrent Solid Tumors, Including Central Nervous System Tumors and Lymphoma
United States20 participantsStarted 2009-08
Plain-language summary
This phase I trial is studying the side effects and best dose of vorinostat when given together with bortezomib in treating young patients with refractory or recurrent solid tumors, including CNS tumors and lymphoma. Vorinostat and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Who can participate
Age range1 Year – 21 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed solid tumors, including CNS tumors or lymphoma
* Histological confirmation not required for the following diagnoses
* Intrinsic brain stem tumors
* Optic pathway gliomas
* Pineal tumors and elevations of cerebral spinal fluid or serum tumor markers, including alpha-fetoprotein or beta-human chorionic gonadotropin, allowed
* Relapsed or refractory disease
* Must have measurable or evaluable tumor
* No known curative therapy or therapy proven to prolong survival with an acceptable quality of life
* Karnofsky performance status (PS) 60-100% for patients \> 16 years of age OR Lansky PS60-100% for patients ≤ 16 years of age
* Neurologic deficits inpatients with CNS tumors must have been relatively stable for a minimum of 1week
* Patients who are unable to walk because ofparalysis, but who are up in a wheelchair, will be considered ambulatory for thepurpose of assessing the performance score
* ANC ≥ 1,000/μL
* Platelet count ≥ 100,000/μL (transfusion independent, defined as not receiving platelet transfusions within the past 7 days)
* Patients with known bone marrow metastatic disease allowed provided they meet the blood count criteria and are not known to be refractory to platelet transfusion
* Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions)
* Patients with known bone marrow metastatic disease allowed provided they meet the blood count criteria and are not know to be refractory to RBC or platelet t…
What they're measuring
1
Maximum-tolerated dose defined as the maximum dose at which fewer than one-third of patients experience DLT according to NCI CTCAE version 3.0