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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00085059 |
RATIONALE: Boron neutron capture therapy using boronophenylalanine-fructose complex may kill tumor cells without harming normal tissue.
PURPOSE: This phase II trial is studying how well boron neutron capture therapy using boronophenylalanine-fructose complex works in treating patients with metastatic melanoma.
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) |
Drug: boronophenylalanine-fructose complex |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Early Phase II Study On BNCT In Metastatic Malignant Melanoma Using The Boron Carrier BPA |
Estimated Enrollment: | 24 |
Study Start Date: | April 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label study.
Patients receive boronophenylalanine-fructose complex IV over 90 minutes followed by boron neutron capture therapy on days 1 and 2.
Patients are followed at 1 and 6 weeks and then every 8 weeks thereafter. In the event of disease progression, patients are followed every 3 months for survival.
PROJECTED ACCRUAL: A total of 16-24 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed melanoma
Metastatic disease
Measurable disease by MRI within the past 4 weeks
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Germany | |
Universitaetsklinikum Essen | |
Essen, Germany, D-45122 |
Investigator: | Andrea Wittig | Universitaetsklinikum Essen |
Study ID Numbers: | CDR0000367229, EORTC-11011 |
Study First Received: | June 10, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00085059 |
Health Authority: | United States: Federal Government |
stage IV melanoma recurrent melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Recurrence Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |