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Sponsors and Collaborators: |
Pediatric Brain Tumor Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00112619 |
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of topotecan when given by intraventricular infusion in treating young patients with neoplastic meningitis due to leukemia, lymphoma, or solid tumors.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors Carcinoma of Unknown Primary Leukemia Lymphoma Metastatic Cancer Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: topotecan hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Supportive Care |
Official Title: | A Phase I Pharmacokinetic Optimal Dosing Study of Intraventricular Topotecan for Children With Neoplastic Meningitis |
Estimated Enrollment: | 49 |
Study Start Date: | August 2005 |
Estimated Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a non-randomized, dose-escalation, multicenter study.
Induction therapy (weeks 1-4): Patients receive topotecan intraventricularly* over 5 minutes on days 1-5 in weeks 1 and 3. Patients then proceed to consolidation therapy in week 5. NOTE: *Patients who are willing, receive 1 intralumbar (instead of intraventricular) dose of topotecan on day
1 of week 3 only.
Once the MTD is determined, the cohort is expanded to 25 patients and the MTD is declared the pharmacokinetic optimal dose provided 23 of 25 patients treated at the MTD achieve the target pharmacokinetic parameter.
PROJECTED ACCRUAL: A total of 28-49 patients will be accrued for this study within 9-24 months.
Ages Eligible for Study: | 3 Years to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of neoplastic meningitis secondary to leukemia, lymphoma (including AIDS-related lymphoma), or solid tumor (including primary CNS tumors or carcinomas of unknown primary site), defined by 1 of the following criteria:
No conventional therapy for neoplastic meningitis exists
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
No uncontrolled infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Concurrent systemic chemotherapy to control systemic disease or bulk CNS disease allowed provided the systemic chemotherapy is not an investigational agent OR any of the following:
Endocrine therapy
Radiotherapy
No concurrent CNS radiotherapy
Surgery
Other
United States, California | |
UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
San Francisco, California, United States, 94115 | |
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |
United States, District of Columbia | |
Children's National Medical Center | Recruiting |
Washington, District of Columbia, United States, 20010-2970 | |
Contact: Clinical Trials Office - Children's National Medical Center 202-884-2549 | |
United States, Illinois | |
Children's Memorial Hospital - Chicago | Recruiting |
Chicago, Illinois, United States, 60614 | |
Contact: Stewart Goldman, MD 773-880-4562 | |
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Mark W. Kieran, MD, PhD 617-632-4907 | |
United States, North Carolina | |
Duke Comprehensive Cancer Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Clinical Trials Office - Duke Comprehensive Cancer Center 888-275-3853 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19104-4318 | |
Contact: Peter C. Phillips, MD 215-590-2107 | |
Children's Hospital of Pittsburgh | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Clinical Trials Office - Children's Hospital of Pittsburgh 412-692-5573 | |
United States, Tennessee | |
St. Jude Children's Research Hospital | Recruiting |
Memphis, Tennessee, United States, 38105 | |
Contact: James M. Boyett, PhD 901-495-4896 | |
United States, Texas | |
Dan L. Duncan Cancer Center at Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor 713-798-1297 | |
United States, Washington | |
Children's Hospital and Regional Medical Center - Seattle | Recruiting |
Seattle, Washington, United States, 98105 | |
Contact: Jeffrey R. Geyer, MD 206-987-6664 |
Investigator: | Stacie Stapleton, MD | Baylor College of Medicine |
Study Chair: | Susan M. Blaney, MD | Baylor College of Medicine |
Study ID Numbers: | CDR0000430504, PBTC-019 |
Study First Received: | June 2, 2005 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00112619 History of Changes |
Health Authority: | Unspecified |
AIDS-related diffuse large cell lymphoma AIDS-related diffuse mixed cell lymphoma AIDS-related diffuse small cleaved cell lymphoma AIDS-related immunoblastic large cell lymphoma AIDS-related lymphoblastic lymphoma AIDS-related peripheral/systemic lymphoma AIDS-related primary CNS lymphoma AIDS-related small noncleaved cell lymphoma HIV-associated Hodgkin lymphoma stage IV childhood Hodgkin lymphoma stage IV childhood large cell lymphoma stage IV childhood lymphoblastic lymphoma stage IV childhood small noncleaved cell lymphoma primary central nervous system lymphoma recurrent childhood acute lymphoblastic leukemia |
recurrent childhood acute myeloid leukemia unspecified childhood solid tumor, protocol specific childhood grade I meningioma childhood grade II meningioma childhood grade III meningioma recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma childhood high-grade cerebral astrocytoma childhood low-grade cerebral astrocytoma childhood choroid plexus tumor childhood craniopharyngioma childhood infratentorial ependymoma childhood supratentorial ependymoma recurrent childhood ependymoma recurrent childhood medulloblastoma |
Neuroectodermal Tumors, Primitive Central Nervous System Neoplasms Acute Myelocytic Leukemia Neoplasm Metastasis Neuroepithelioma Glioma Hodgkin Disease Nervous System Neoplasms Lymphoma, Large B-Cell, Diffuse Neoplasms, Unknown Primary Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Astrocytoma Acquired Immunodeficiency Syndrome Juvenile Myelomonocytic Leukemia |
Leukemia, Myeloid Carcinoma Neuroectodermal Tumors HIV Infections Chronic Myelogenous Leukemia Topotecan Lymphoma, Non-Hodgkin Neoplasms, Glandular and Epithelial Acute Lymphoblastic Leukemia, Childhood Choroid Plexus Neoplasms Leukemia, Lymphoid Rhabdoid Tumor Hodgkin Lymphoma, Childhood Central Nervous System Lymphoma, Primary Leukemia, Myeloid, Acute |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Central Nervous System Neoplasms Meningitis Leukemia Neoplastic Processes Pathologic Processes Neoplasms by Site Therapeutic Uses Neoplasm Metastasis Lymphoma Nervous System Neoplasms Neoplasms, Unknown Primary Neoplasms by Histologic Type |
Immunoproliferative Disorders Immune System Diseases Nervous System Diseases Central Nervous System Diseases Enzyme Inhibitors Pharmacologic Actions Carcinoma Lymphatic Diseases Neoplasms Central Nervous System Infections Lymphoproliferative Disorders Topotecan Neoplasms, Glandular and Epithelial |