Boron Neutron Capture Therapy in Treating Patients With M... | NCT00059800

Studies
Boron Neutron Capture Therapy in Treating Patients With Melanoma

NCT00059800

Sponsor

Beth Israel Deaconess Medical Center

Status

Completed

Last Update Posted

Jun 26, 2013Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Melanoma (Skin)

Interventions

boron neutron capture therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CDR0000287207	Registry Identifier	PDQ (Physician Data Query)
BIDMC-2001-P-001946

Status Module

Record Verification Date

Dec 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2002

Primary Completion Date

Not provided

Completion Date

Jan 2004Actual

First Submitted Date

May 6, 2003

First Submission Date that Met QC Criteria

May 6, 2003

First Posted Date

May 7, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2013

Last Update Posted Date

Jun 26, 2013Estimated

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
boron neutron capture therapy	Radiation

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Measure	Description	Time Frame
Clinical response
Time course, uniformity, and severity of acute dermal reactions
Late dermal reaction after at least six months
Pharmacokinetics

Facility	Status	City	State	ZIP	Country	Contacts
Beth Israel Deaconess Medical Center		Boston	Massachusetts	02215	United States
Massachusetts Institute of Technology

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

ID	Term
D017247	Neutron Capture Therapy
D011882	Radiotherapy, High-Energy
D011878	Radiotherapy
D013812	Therapeutics