Boron Neutron Capture Therapy in Treating Patients With Melanoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Beth Israel Deaconess Medical Center
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00059800
First received: May 6, 2003
Last updated: February 6, 2009
Last verified: December 2005
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Purpose
RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue.
PURPOSE: Phase II trial to study the effectiveness of boron neutron capture therapy in treating patients who have melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Radiation: boron neutron capture therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Primary Purpose: Treatment |
| Official Title: | A Phase II Trial For Neutron Capture Therapy In Melanoma |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Clinical response [ Designated as safety issue: No ]
- Time course, uniformity, and severity of acute dermal reactions [ Designated as safety issue: No ]
- Late dermal reaction after at least six months [ Designated as safety issue: No ]
- Pharmacokinetics [ Designated as safety issue: No ]
| Study Start Date: | May 2002 |
OBJECTIVES:
- Determine the clinical response, by serial objective measurements, in patients with melanoma treated with boron neutron capture therapy.
- Determine the time course, uniformity, and severity of acute dermal reactions in patients treated with this regimen.
- Determine the late dermal reactions in patients who are followed for at least 6 months after treatment with this regimen.
- Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: Patients are stratified according to tumor size (no greater than 15 cc vs greater than 15 cc).
Patients undergo boron neutron capture therapy.
Patients are followed for 3 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00059800
Locations
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Massachusetts Institute of Technology | |
| Cambridge, Massachusetts, United States, 02139 | |
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
| Study Chair: | Paul M. Busse, MD, PhD | Beth Israel Deaconess Medical Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00059800 History of Changes |
| Other Study ID Numbers: | CDR0000287207, BIDMC-W-01-0380-FB, BIDMC-2001-P-001946 |
| Study First Received: | May 6, 2003 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent melanoma stage 0 melanoma stage I melanoma |
stage II melanoma stage III melanoma stage IV melanoma |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue |
Nevi and Melanomas Boron Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013