Boron Neutron Capture Therapy Using Boronophenylalanine-Fructose Complex in Treating Patients With Metastatic Melanoma

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Boron neutron capture therapy using boronophenylalanine-fructose complex may kill tumor cells without harming normal tissue.

PURPOSE: This phase II trial is studying how well boron neutron capture therapy using boronophenylalanine-fructose complex works in treating patients with metastatic melanoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed melanoma

• Metastatic disease

• Brain metastases, skin metastases, or soft tissue metastases of the head and neck or the extremities

• Accessible lesion(s) for boron neutron capture therapy (BNCT)

• No clear progression of disease at other sites than the ones intended for treatment with surgery and/or BNCT

• Measurable disease by MRI within the past 4 weeks

• Lesion(s) ≥ 10 mm in diameter

• Indication for palliative radiotherapy that is intended to be delivered as BNCT

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• Neutrophil count ≥ 2,000/mm^3

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 10 g/dL

Hepatic

• Bilirubin ≤ 2.5 times upper limit of normal (ULN)*

• Transaminases ≤ 2.5 times ULN*

• Alkaline phosphatase ≤ 2.5 times ULN* NOTE: *Unless due to reversible reaction to antiseizure medication

Renal

• Creatinine ≤ 2.5 times ULN

• Blood urea nitrogen ≤ 2.5 times ULN

Cardiovascular

• No congestive heart failure

• No newly diagnosed or unstable angina pectoris

• No uncontrolled arrhythmias

• No uncontrolled conduction defects

• No recent coronary artery disease

• No other severe heart disease

Pulmonary

• No severe pulmonary disease, including severe obstructive or restrictive lung disease

Other

• No history of phenylketonuria

• No severe gastrointestinal disease

• No active peptic ulcer disease

• No uncontrolled endocrine disease

• No pre-existing serious mental or organic brain disease (e.g., epilepsy)

• No psychological, familial, sociological, or geographical condition that would preclude study compliance

• Able to travel to the Netherlands via public transportation

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent immunologic or biologic therapy

• No concurrent colony-stimulating factors (e.g., epoetin alfa or filgrastim [G-CSF])

Chemotherapy

• No concurrent chemotherapy

Endocrine therapy

• No concurrent hormonal therapy

Radiotherapy

• No prior radiotherapy to site(s) proposed for study treatment

• No other concurrent radiotherapy

Surgery

• See Disease Characteristics

Other

• Recovered from all prior anti-tumor therapy (excluding alopecia and sensitive peripheral neuropathy ≤ grade 2)

• No other concurrent anticancer therapy

• No other concurrent investigational drugs