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

This study has been terminated.
(low accrual)
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00085059
First received: June 10, 2004
Last updated: July 17, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin)
Drug: boronophenylalanine-fructose complex
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Phase II Study On BNCT In Metastatic Malignant Melanoma Using The Boron Carrier BPA

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • Best response to treatment as measured by RECIST every 8 weeks at completion of study treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival as measured every 8 weeks at completion of study treatment [ Designated as safety issue: No ]
  • Duration of local response as measured by Kaplan Meier every 8 weeks after completion of study treatment [ Designated as safety issue: No ]
  • Time to local progression measured every 8 weeks after completion of study treatment [ Designated as safety issue: No ]
  • Acute toxicity as measured by Common Toxicity Criteria AE v 3.0 1- 6 weeks after completion of treatment [ Designated as safety issue: Yes ]
  • Late toxicity as measured by RTOG and EORTC week 6 and thereafter upon completion of study treatment [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: April 2004
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
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 the objective local response in patients treated with this regimen.

Secondary

  • Determine the overall survival of patients treated with this regimen.
  • Determine the duration of local response and time to local progression in patients treated with this regimen.
  • Determine the dose-response relationship at the per-lesion level in patients treated with this regimen.
  • Determine the safety of this regimen in these patients.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive boronophenylalanine-fructose complex IV over 90 minutes followed by boron neutron capture therapy on days 1 and 2.

Patients are followed at 1 and 6 weeks and then every 8 weeks thereafter. In the event of disease progression, patients are followed every 3 months for survival.

PROJECTED ACCRUAL: A total of 16-24 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00085059

Locations
Germany
Universitaetsklinikum Essen
Essen, Germany, D-45122
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Andrea Wittig Universitaetsklinikum Essen
  More Information

Additional Information:
Publications:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00085059     History of Changes
Other Study ID Numbers: EORTC-11011, EORTC-11011
Study First Received: June 10, 2004
Last Updated: July 17, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage IV melanoma
recurrent melanoma

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

ClinicalTrials.gov processed this record on April 16, 2014