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| Sponsors and Collaborators: |
Oregon Health and Science University Cancer Institute 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 Von Hippel-Lindau Syndrome |
Drug: mannitol Drug: melphalan |
Phase I |
| Genetics Home Reference related topics: | von Hippel-Lindau syndrome |
| MedlinePlus related topics: | Cancer Lymphoma Von Hippel-Lindau Disease |
| ChemIDplus related topics: | Melphalan Melphalan hydrochloride Sarcolysin Mannitol Mechlorethamine Mechlorethamine hydrochloride Phenylalanine |
| 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 | |||||
| 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 | |||||
| Oregon Health and Science University Cancer Institute |
| National Cancer Institute (NCI) |
| Principal Investigator: | Edward A. Neuwelt, MD | Oregon Health and Science University Cancer Institute |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000445051, OHSU-1299, OHSU-ONC-98018-L, OHSU-4834 |
| First Received: | November 11, 2005 |
| Last Updated: | August 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00253721 |
| Health Authority: | Unspecified |
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