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Status:

TERMINATED

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

Lead Sponsor:

European Organisation for Research and Treatment of Cancer - EORTC

Conditions:

Melanoma (Skin)

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief 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...

Detailed Description

OBJECTIVES: Primary * Determine the therapeutic activity and efficacy of boron neutron capture therapy using boronophenylalanine-fructose complex in patients with metastatic melanoma. * Determine th...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    4 Patients enrolled

    Trial Details

    Trial ID

    NCT00085059

    Start Date

    April 1 2004

    Last Update

    July 18 2012

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Universitaetsklinikum Essen

    Essen, Germany, D-45122