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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00059800 |
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Date of registration:
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06/05/2003 |
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Primary sponsor: |
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Public title:
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Boron Neutron Capture Therapy in Treating Patients With Melanoma
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Scientific title:
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A Phase II Trial For Neutron Capture Therapy In Melanoma |
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Date of first enrolment:
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May 2002 |
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Target sample size:
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00059800 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Paul M. Busse, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Beth Israel Deaconess Medical Center |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Histologically confirmed melanoma
- Evaluable disease
- Lesion(s) to be irradiated must be located in 1 of the following areas:
- On an extremity
- On the head or neck (including the scalp)
- In the subdermal lymphatics (excluding the proximal axilla)
- Area to be irradiated must not exceed a maximum dimension of 10 cm
- Maximum tumor depth from the surface of the skin cannot exceed 6 cm
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- More than 6 months
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Creatinine normal
Cardiovascular
- No history of severe cardiac disease
- No uncontrolled arrhythmias or conduction defects
- No unstable or newly diagnosed angina pectoris
- No recent coronary artery disease
- No congestive heart failure
Other
- Not pregnant
- Negative pregnancy test
- No history of phenylketonuria
- Must have sufficient mental competence
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy to study sites
Surgery
- Not specified
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Melanoma (Skin)
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Intervention(s)
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Radiation: boron neutron capture therapy
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Primary Outcome(s)
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Clinical response
[Time Frame: No]
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Late dermal reaction after at least six months
[Time Frame: No]
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Pharmacokinetics
[Time Frame: No]
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Time course, uniformity, and severity of acute dermal reactions
[Time Frame: No]
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Secondary ID(s)
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BIDMC-2001-P-001946
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BIDMC-W-01-0380-FB
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CDR0000287207
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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