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

Primary Purpose

Melanoma (Skin)

Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
boronophenylalanine-fructose complex
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, recurrent melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitaetsklinikum Essen

Outcomes

Primary Outcome Measures

Best response to treatment as measured by RECIST every 8 weeks at completion of study treatment

Secondary Outcome Measures

Overall survival as measured every 8 weeks at completion of study treatment
Duration of local response as measured by Kaplan Meier every 8 weeks after completion of study treatment
Time to local progression measured every 8 weeks after completion of study treatment
Acute toxicity as measured by Common Toxicity Criteria AE v 3.0 1- 6 weeks after completion of treatment
Late toxicity as measured by RTOG and EORTC week 6 and thereafter upon completion of study treatment

Full Information

First Posted
June 10, 2004
Last Updated
July 17, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00085059
Brief Title
Boron Neutron Capture Therapy Using Boronophenylalanine-Fructose Complex in Treating Patients With Metastatic Melanoma
Official Title
Early Phase II Study On BNCT In Metastatic Malignant Melanoma Using The Boron Carrier BPA
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
April 2004 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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 capture therapy using boronophenylalanine-fructose complex works in treating patients with metastatic melanoma.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
boronophenylalanine-fructose complex
Primary Outcome Measure Information:
Title
Best response to treatment as measured by RECIST every 8 weeks at completion of study treatment
Secondary Outcome Measure Information:
Title
Overall survival as measured every 8 weeks at completion of study treatment
Title
Duration of local response as measured by Kaplan Meier every 8 weeks after completion of study treatment
Title
Time to local progression measured every 8 weeks after completion of study treatment
Title
Acute toxicity as measured by Common Toxicity Criteria AE v 3.0 1- 6 weeks after completion of treatment
Title
Late toxicity as measured by RTOG and EORTC week 6 and thereafter upon completion of study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Wittig
Organizational Affiliation
Universitaetsklinikum Essen
Official's Role
Study Chair
Facility Information:
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
D-45122
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
16362787
Citation
Wittig A, Moss RL, Stecher-Rasmussen F, Appelman K, Rassow J, Roca A, Sauerwein W. Neutron activation of patients following boron neutron capture therapy of brain tumors at the high flux reactor (HFR) Petten (EORTC Trials 11961 and 11011). Strahlenther Onkol. 2005 Dec;181(12):774-82. doi: 10.1007/s00066-005-1433-4.
Results Reference
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Boron Neutron Capture Therapy Using Boronophenylalanine-Fructose Complex in Treating Patients With Metastatic Melanoma

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