Vorinostat With or Without Isotretinoin in Treating Young Patients With Recurrent or Refractory S… (NCT00217412) | Clinical Trial Compass
CompletedPhase 1
Vorinostat With or Without Isotretinoin in Treating Young Patients With Recurrent or Refractory Solid Tumors, Lymphoma, or Leukemia
United States60 participantsStarted 2005-08
Plain-language summary
This phase I trial is studying the side effects and best dose of vorinostat when given together with isotretinoin in treating young patients with recurrent or refractory solid tumors, lymphoma, or leukemia. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Isotretinoin may cause cancer cells to look more like normal cells, and to grow and spread more slowly. Giving vorinostat together with isotretinoin may be an effective treatment for cancer.
Who can participate
Age range1 Year – 21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed\* diagnosis of 1 of the following:
* Recurrent or refractory solid tumor or lymphoma (for patients in group 1)
* Measurable or evaluable disease
* Recurrent or refractory leukemia (for patients in group 2)
* Greater than 25% blasts in the bone marrow (i.e., M3 bone marrow)
* Active extramedullary disease allowed except leptomeningeal disease
* Recurrent or refractory CNS tumor of 1 of the following types (for patients in group 3):
* Neuroblastoma
* Medulloblastoma/CNS primitive neuroectodermal tumor
* Atypical teratoid rhabdoid tumor
* No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists
* No bone marrow involvement by disease (for patients in groups 1 and 3)
* No active CNS leukemia
* Performance status - Lansky 50-100% (for patients ≤ 10 years of age)
* Performance status - Karnofsky 60-100% (for patients \> 10 years of age)
* Absolute neutrophil count ≥ 1,000/mm\^3 (for solid tumor patients)
* Platelet count ≥ 100,000/mm\^3\* (for solid tumor patients) (20,000/mm\^3\*\* for leukemia patients)
* Hemoglobin ≥ 8.0 g/dL (RBC transfusion allowed) (for solid tumor and leukemia patients)
* Triglycerides \< 300 mg/dL (for patients in group 3)
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT ≤ 5 times ULN
* Albumin ≥ 2 g/dL
* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min
* Creatinine based on age as follows:
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What they're measuring
1
Maximum tolerated dose (MTD) defined as the maximum dose at which fewer than one-third of patients experience dose-limiting toxicities DLT graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0