Boron Neutron Capture Therapy in Treating Patients With Melanoma - Full Text View

Sponsor:	Beth Israel Deaconess Medical Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00059800

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Active Control
Official Title:	A Phase II Trial For Neutron Capture Therapy In Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Melanoma

U.S. FDA Resources

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

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.

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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000287207, BIDMC-W-01-0380-FB, BIDMC-2001-P-001946
Study First Received:	May 6, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00059800 History of Changes
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:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on November 27, 2009