Boron Neutron Capture Therapy in Treating Patients With Stage III Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002781
Recruitment Status : Unknown
Verified April 2000 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : September 2, 2004
Last Update Posted : September 17, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Drug: boronophenylalanine-fructose complex Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Primary Purpose: Treatment
Study Start Date : April 1996

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002781

United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Study Chair: Paul M. Busse, MD, PhD Beth Israel Deaconess Medical Center Identifier: NCT00002781     History of Changes
Other Study ID Numbers: CDR0000064811
First Posted: September 2, 2004    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: April 2000

Keywords provided by National Cancer Institute (NCI):
stage III melanoma
recurrent melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas