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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 September 18, 2014