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| Sponsor: | Oregon Health and Science University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00253721 |
Purpose
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 Metastatic Cancer 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.
Eligibility| 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
Contacts and Locations| United States, Oregon | |
| Knight Cancer Institute at Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239-3098 | |
| Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea 503-494-1080 trials@ohsu.edu | |
| Principal Investigator: | Edward A. Neuwelt, MD | OHSU Knight Cancer Institute |
More Information
| Study ID Numbers: | CDR0000445051, OHSU-1299, OHSU-ONC-98018-L, OHSU-4834 |
| Study First Received: | November 11, 2005 |
| Last Updated: | August 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00253721 History of Changes |
| 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 tumors metastatic to brain adult mixed glioma childhood mixed glioma |
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Melphalan Angiomatosis Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Diuretics Neoplasms, Nerve Tissue Central Nervous System Neoplasms Chordoma Neoplastic Processes Pathologic Processes Neoplasms by Site Von Hippel-Lindau Disease Mannitol |
Therapeutic Uses Neoplasms, Germ Cell and Embryonal Syndrome Neoplasm Metastasis Cardiovascular Diseases Glioma Alkylating Agents Lymphoma Nervous System Neoplasms Neurocutaneous Syndromes Neoplasms by Histologic Type Immunoproliferative Disorders Disease Astrocytoma Immune System Diseases |