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Sponsors and Collaborators: |
Oregon Health and Science University Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00253721 |
RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving drugs directly into the arteries around the tumor may kill more tumor cells. Mannitol may open the blood vessels around the brain and allow melphalan to be carried directly to the brain. Giving melphalan together with mannitol may be an effective treatment for central nervous system cancer.
PURPOSE: This phase I trial is studying side effects and best dose of melphalan when given together with mannitol in treating patients with central nervous system cancer.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors Chordoma Lymphoma Von Hippel-Lindau Syndrome |
Drug: mannitol Drug: melphalan |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Intra-Arterial Melphalan (L-Phenylalanine Mustard) Administered in Conjunction With Osmotic Blood-Brain Barrier Disruption in Patients With Brain Malignancies: A Phase I Study |
Estimated Enrollment: | 20 |
Study Start Date: | May 1998 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of melphalan.
Patients receive intra-arterial mannitol followed by melphalan over 10 minutes on days 1 and 2*. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients with gliomas localized to the posterior circulation (i.e., brain stem gliomas) receive melphalan on day 1 only.
Cohorts of 3-6 patients receive escalating doses of melphalan 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.
After completion of study therapy, patients are followed periodically for at least 1 year.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Ages Eligible for Study: | 1 Year and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary or metastatic CNS malignancy
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
United States, Oregon | |
Oregon Health and Science University Cancer Institute | Recruiting |
Portland, Oregon, United States, 97239-3098 | |
Contact: Clinical Trials Office - Oregon Health and Science University 503-494-1080 trials@ohsu.edu |
Principal Investigator: | Edward A. Neuwelt, MD | Oregon Health and Science University Cancer Institute |
Study ID Numbers: | CDR0000445051, OHSU-1299, OHSU-ONC-98018-L, OHSU-4834 |
Study First Received: | November 11, 2005 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00253721 |
Health Authority: | Unspecified |
adult anaplastic astrocytoma adult brain stem glioma adult diffuse astrocytoma adult giant cell glioblastoma adult gliosarcoma adult central nervous system germ cell tumor adult choroid plexus tumor adult craniopharyngioma adult ependymoblastoma adult medulloblastoma adult supratentorial primitive neuroectodermal tumor (PNET) adult anaplastic ependymoma adult ependymoma adult myxopapillary ependymoma adult subependymoma |
adult anaplastic meningioma adult melanocytic lesion adult meningeal hemangiopericytoma adult grade I meningioma adult grade II meningioma adult grade III meningioma adult anaplastic oligodendroglioma adult oligodendroglioma adult pineoblastoma adult pineocytoma adult pilocytic astrocytoma adult papillary meningioma adult tumors metastatic to brain adult mixed glioma childhood mixed glioma |
Melphalan Glioblastoma Choroid Plexus Neoplasms Neuroectodermal Tumors, Primitive Angiomatosis Von Hippel-Lindau syndrome Central Nervous System Neoplasms Chordoma Ependymoma Central nervous system lymphoma, primary Von Hippel-Lindau Disease Mannitol Neoplasms, Germ Cell and Embryonal Craniopharyngioma Neuroepithelioma |
Meningioma Glioma Choroid Plexus neoplasms Lymphoma Nervous System Neoplasms Neurocutaneous Syndromes Immunoproliferative Disorders Astrocytoma Vascular Diseases Hemangiopericytoma Recurrence Lymphatic Diseases Neuroectodermal Tumors Brain Neoplasms Mechlorethamine |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Diuretics Neoplasms, Nerve Tissue Physiological Effects of Drugs Pathologic Processes Neoplasms by Site Syndrome Therapeutic Uses Cardiovascular Diseases Alkylating Agents Disease |
Neoplasms by Histologic Type Immune System Diseases Diuretics, Osmotic Nervous System Diseases Cardiovascular Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Natriuretic Agents Myeloablative Agonists Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial |