Melanoma (Skin)Phase 2NCT00059800
Boron Neutron Capture Therapy in Treating Patients With Melanoma
A Phase 2 study testing boron neutron capture therapy in people with Melanoma (Skin), run by Beth Israel Deaconess Medical Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- boron neutron capture therapy
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- May 2002to Jan 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Massachusetts Institute of Technology
Cambridge, Massachusetts, 02139
About this study
Official title: A Phase II Trial For Neutron Capture Therapy In Melanoma
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.
Read the detailed description
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.
- Conditions
- Melanoma (Skin)
- Being tested
- boron neutron capture therapy
- Keywords
- recurrent melanoma, stage 0 melanoma, stage I melanoma, stage II melanoma, stage III melanoma, stage IV melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
boron neutron capture therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
Time course, uniformity, and severity of acute dermal reactions
Late dermal reaction after at least six months
Pharmacokinetics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2003 (estimated)
- Study startMay 2002
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Paul M. Busse, MD, PhD, Study chair, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00059800
- Sponsor's protocol ID
- BIDMC-W-01-0380-FB
- Other IDs
- CDR0000287207, BIDMC-2001-P-001946
- Status last verified
- Dec 2005
- First submitted
- 6 May 2003
- Last updated
- 26 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial For Neutron Capture Therapy In Melanoma
- ClinicalTrials.gov ID
- NCT00059800
- Acronym / sponsor ID
- BIDMC-W-01-0380-FB
- Conditions
- Melanoma (Skin)
- Keywords
- recurrent melanoma, stage 0 melanoma, stage I melanoma, stage II melanoma, stage III melanoma, stage IV melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- May 2002
- Study completion
- Jan 2004 (actual)
- First posted
- 7 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| boron neutron capture therapy | Radiation | – |
Primary outcome
Clinical response
Time course, uniformity, and severity of acute dermal reactions
Late dermal reaction after at least six months
Pharmacokinetics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul M. Busse, MD, PhD study chair
Beth Israel Deaconess Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing boron neutron capture therapy in people with Melanoma (Skin), run by Beth Israel Deaconess Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2013.