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Early Phase II Study On BNCT In Metastatic Malignant Melanoma Using The Boron Carrier BPA


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

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Trial Information

Early Phase II Study On BNCT In Metastatic Malignant Melanoma Using The Boron Carrier BPA


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Andrea Wittig

Investigator Role:

Study Chair

Investigator Affiliation:

Universitaetsklinikum Essen

Authority:

United States: Federal Government

Study ID:

EORTC-11011

NCT ID:

NCT00085059

Start Date:

April 2004

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

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