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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00217412 |
RATIONALE: 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.
PURPOSE: 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.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors Leukemia Lymphoma Neuroblastoma Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: isotretinoin Drug: vorinostat |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of SAHA (NSC#: 701852 IND#: 71976) in Pediatric Patients With Recurrent or Refractory Solid Tumors (Including Lymphomas) and Leukemia Followed By a Phase I Study of SAHA in Combination With 13-Cis-Retinoic Acid for Patients With Selected Recurrent/Refractory Solid Tumors |
Estimated Enrollment: | 60 |
Study Start Date: | August 2005 |
Estimated Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of vorinostat (SAHA).
Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients may be treated at the MTD.
The MTD of SAHA is determined as in group 1. An additional 6 patients may be treated at the MTD.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A maximum of 60 patients will be accrued for this study.
Ages Eligible for Study: | 1 Year to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed* diagnosis of 1 of the following:
Recurrent or refractory solid tumor or lymphoma (for patients in group 1)
Recurrent or refractory leukemia (for patients in group 2)
Recurrent or refractory CNS tumor of 1 of the following types (for patients in group 3):
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
NOTE: **Transfusion allowed
Hepatic
Renal
Creatinine based on age as follows:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
At least 2 months since prior stem cell transplantation or rescue
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Maryam Fouladi, MD | Children's Hospital Medical Center, Cincinnati |
Investigator: | Julie R. Park, MD | Children's Hospital and Regional Medical Center, Seattle |
Study ID Numbers: | CDR0000440999, COG-ADVL0416, NCI-06-C-0254 |
Study First Received: | September 20, 2005 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00217412 |
Health Authority: | United States: Food and Drug Administration |
recurrent childhood supratentorial primitive neuroectodermal tumor recurrent childhood medulloblastoma childhood atypical teratoid/rhabdoid tumor recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia juvenile myelomonocytic leukemia recurrent/refractory childhood Hodgkin lymphoma recurrent childhood grade III lymphomatoid granulomatosis childhood diffuse large cell lymphoma childhood immunoblastic large cell lymphoma |
recurrent childhood large cell lymphoma recurrent childhood lymphoblastic lymphoma Burkitt lymphoma recurrent childhood small noncleaved cell lymphoma unspecified childhood solid tumor, protocol specific recurrent neuroblastoma childhood acute promyelocytic leukemia (M3) childhood chronic myelogenous leukemia relapsing chronic myelogenous leukemia |
Juvenile myelomonocytic leukemia Leukemia, Lymphoid Hodgkin's disease Neuroectodermal Tumors, Primitive Rhabdoid Tumor Chronic myelogenous leukemia Central Nervous System Neoplasms Leukemia, Myeloid, Acute Small non-cleaved cell lymphoma Lymphoma, large-cell, immunoblastic Neuroblastoma Lymphoma, large-cell Lymphomatoid granulomatosis Burkitt's lymphoma Leukemia |
Neoplasms, Germ Cell and Embryonal Lymphoma, Large-Cell, Immunoblastic Isotretinoin Leukemia, Promyelocytic, Acute Neuroepithelioma Acute myelocytic leukemia Hodgkin Disease Lymphoma Nervous System Neoplasms Lymphoma, Large B-Cell, Diffuse Lymphomatoid Granulomatosis Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Vorinostat Acute promyelocytic leukemia |
Anti-Inflammatory Agents Anticarcinogenic Agents Disease Attributes Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Pathologic Processes Neoplasms by Site Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics |
Dermatologic Agents Neoplasms by Histologic Type Immune System Diseases Nervous System Diseases Enzyme Inhibitors Protective Agents Pharmacologic Actions Neoplasms Analgesics, Non-Narcotic Peripheral Nervous System Agents Neoplasms, Neuroepithelial Antirheumatic Agents Central Nervous System Agents |