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

NCT00085059 | Terminated Phase 2

• 1 other identifier: EORTC-11011
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

• 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

Interventions

boronophenylalanine-fructose complex DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (1)

Universitaetsklinikum Essen

Essen, D-45122, Germany

Location

Related Publications (1)

• 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.

  PMID: 16362787 BACKGROUND

MeSH Terms

Conditions

Melanoma

Interventions

4-boronophenylalanine-fructose

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Andrea Wittig

  Universitaetsklinikum Essen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: April 1, 2004
• Primary Completion: October 1, 2006
• Last Updated: July 18, 2012

Record last verified: 2012-07

Locations

DE (1)