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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00217412 |
Purpose
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 |
|---|---|---|
|
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 |
| Primary Completion Date: | September 2009 (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.
Eligibility| 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
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Children's Hospital of Orange County | |
| Orange, California, United States, 92868 | |
| Stanford Cancer Center | |
| Stanford, California, United States, 94305-5824 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010-2970 | |
| United States, Illinois | |
| Children's Memorial Hospital - Chicago | |
| Chicago, Illinois, United States, 60614 | |
| United States, Indiana | |
| Indiana University Melvin and Bren Simon Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | |
| Ann Arbor, Michigan, United States, 48109-0286 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| SUNY Upstate Medical University Hospital | |
| Syracuse, New York, United States, 13210 | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| United States, Oregon | |
| Oregon Health and Science University Cancer Institute | |
| Portland, Oregon, United States, 97239-3098 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104-9786 | |
| United States, Tennessee | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
| United States, Texas | |
| Baylor University Medical Center - Houston | |
| Houston, Texas, United States, 77030-2399 | |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | |
| Dallas, Texas, United States, 75390 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | |
| Seattle, Washington, United States, 98105 | |
| Canada, Ontario | |
| Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Canada, Quebec | |
| Hopital Sainte Justine | |
| Montreal, Quebec, Canada, H3T 1C5 | |
| Study Chair: | Maryam Fouladi, MD | Children's Hospital Medical Center, Cincinnati |
| Investigator: | Julie R. Park, MD | Seattle Children's Hospital |
More Information
| Study ID Numbers: | CDR0000440999, COG-ADVL0416, NCI-06-C-0254 |
| Study First Received: | September 20, 2005 |
| Last Updated: | October 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00217412 History of Changes |
| 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 |
|
Anticarcinogenic Agents Anti-Inflammatory Agents Disease Attributes Neuroectodermal Tumors, Primitive Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Central Nervous System Neoplasms Neuroblastoma Leukemia Neoplasms by Site Pathologic Processes Sensory System Agents Therapeutic Uses |
Neoplasms, Germ Cell and Embryonal Isotretinoin Anti-Inflammatory Agents, Non-Steroidal Analgesics Dermatologic Agents Lymphoma Nervous System Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Nervous System Diseases Vorinostat Enzyme Inhibitors Protective Agents Pharmacologic Actions |