Melanoma (Skin)Phase 1NCT00002781
Boron Neutron Capture Therapy in Treating Patients With Stage III Melanoma
A Phase 1 study testing boronophenylalanine-fructose complex 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 I trial to study the effectiveness of boron neuron capture therapy in treating patients with stage III 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?
- boronophenylalanine-fructose complex
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 1996to not given
- Phase
- Phase 1
- 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: Biopsy-proven melanoma that is clinical stage III Estimated clinical tumor depth 1.0-6.0 cm from the epidermis Tumor surface diameter no greater than 10 cm Grossly evident cutaneous or subcutaneous tumor nodules are eligible for irradiation
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70%-100% Life expectancy: More than 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No history of phenylketonuria Negative serum pregnancy test required of fertile women Adequate contraception required of fertile women during and for 6 months after the study
PRIOR CONCURRENT THERAPY: No prior radiotherapy to the target area
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston University School of Medicine
Boston, Massachusetts, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: PROCEDURES FOR BNCT PHASE-I STUDY OF MELANOMA IN THE EXTREMITIES
RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue.
PURPOSE: Phase I trial to study the effectiveness of boron neuron capture therapy in treating patients with stage III melanoma.
Read the detailed description
OBJECTIVES: I. Estimate the maximum tolerated dose of neutron irradiation that can be given in combination with borophenylalanine-fructose complex (BPA-F) in patients with stage III melanoma. II. Evaluate the safety of this regimen. III. Evaluate tumor response to this regimen.
OUTLINE: This is a dose-finding study. Patients receive a test dose of borophenylalanine-fructose complex (BPA-F) for biodistribution studies and undergo punch biopses of tumor and normal tissue to measure B-10 concentration. Later, a treatment dose of BPA-F over 1 hour is followed by neutron irradiation. Groups of 3 patients receive escalated doses of neutron irradiation until the maximum tolerated dose is determined. Patients who complete protocol treatment and continue to meet the eligibility criteria may re-enter the study, provided at least 6 months has elapsed since the completion of prior therapy and the field boundary for the new irradiation site is seperated from the boundary of the previously irradiated site. Patients are followed monthly for 12 months, then every 3-6 months as needed.
PROJECTED ACCRUAL: Approximately 15 patients will be entered.
- Conditions
- Melanoma (Skin)
- Being tested
- boronophenylalanine-fructose complex
- Keywords
- stage III melanoma, recurrent melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
boronophenylalanine-fructose complexDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2004 (estimated)
- Study startApr 1996
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 1
- Primary purpose
- Treatment
- Enrolment
- 15 participants (estimated)
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
- NCT00002781
- Sponsor's protocol ID
- CDR0000064811
- Other IDs
- NEDH-961207015, NCI-V96-0907
- Status last verified
- Apr 2000
- First submitted
- 1 Nov 1999
- Last updated
- 17 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROCEDURES FOR BNCT PHASE-I STUDY OF MELANOMA IN THE EXTREMITIES
- ClinicalTrials.gov ID
- NCT00002781
- Acronym / sponsor ID
- CDR0000064811
- Conditions
- Melanoma (Skin)
- Keywords
- stage III melanoma, recurrent melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Apr 1996
- First posted
- 2 Sep 2004 (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 I trial to study the effectiveness of boron neuron capture therapy in treating patients with stage III melanoma.
Detailed description
OBJECTIVES: I. Estimate the maximum tolerated dose of neutron irradiation that can be given in combination with borophenylalanine-fructose complex (BPA-F) in patients with stage III melanoma. II. Evaluate the safety of this regimen. III. Evaluate tumor response to this regimen.
OUTLINE: This is a dose-finding study. Patients receive a test dose of borophenylalanine-fructose complex (BPA-F) for biodistribution studies and undergo punch biopses of tumor and normal tissue to measure B-10 concentration. Later, a treatment dose of BPA-F over 1 hour is followed by neutron irradiation. Groups of 3 patients receive escalated doses of neutron irradiation until the maximum tolerated dose is determined. Patients who complete protocol treatment and continue to meet the eligibility criteria may re-enter the study, provided at least 6 months has elapsed since the completion of prior therapy and the field boundary for the new irradiation site is seperated from the boundary of the previously irradiated site. Patients are followed monthly for 12 months, then every 3-6 months as needed.
PROJECTED ACCRUAL: Approximately 15 patients will be entered.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| boronophenylalanine-fructose complex | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
Related trials for Melanoma (Skin)
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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 1 study testing boronophenylalanine-fructose complex 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: status not confirmed, as of the sponsor's last update on 17 Sep 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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.
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 17 Sep 2013.