Vorinostat With or Without Isotretinoin in Treating Young Patients With Recurrent or Refractory Solid Tumors, Lymphoma, or Leukemia

Completed · Phase 1

Conditions studied: Childhood Acute Promyelocytic Leukemia (M3), Childhood Atypical Teratoid/Rhabdoid Tumor, Childhood Burkitt Lymphoma, Childhood Chronic Myelogenous Leukemia, Childhood Diffuse Large Cell Lymphoma, Childhood Immunoblastic Large Cell Lymphoma, Juvenile Myelomonocytic Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Grade III Lymphomatoid Granulomatosis, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Medulloblastoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor, Recurrent Neuroblastoma, Recurrent/Refractory Childhood Hodgkin Lymphoma, Relapsing Chronic Myelogenous Leukemia, Unspecified Childhood Solid Tumor, Protocol Specific

In brief

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.

Key facts

Study ID

NCT00217412

Run by

National Cancer Institute (NCI)

People needed

60

Starts

2005-08-01

Expected to finish

2009-09-01

Last updated by the study team

2014-06-17

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• No greater than 0.8 mg/dL (for patients ≤ 5 years of age)

Where it is running

• Children's Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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