NCT00002781

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1996

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.8 years until next milestone

First Posted

Study publicly available on registry

September 2, 2004

Completed
Last Updated

September 17, 2013

Status Verified

April 1, 2000

First QC Date

November 1, 1999

Last Update Submit

September 16, 2013

Conditions

Melanoma (Skin)

Keywords

stage III melanomarecurrent melanoma

Interventions

boronophenylalanine-fructose complexDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

4-boronophenylalanine-fructose

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Paul M. Busse, MD, PhD

    Beth Israel Deaconess Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

September 2, 2004

Study Start

April 1, 1996

Last Updated

September 17, 2013

Record last verified: 2000-04

Locations

US(2)