Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Boronophenylalanine-Fructose Complex (BPA-F) and/or Sodium Borocaptate (BSH) Followed By Surgery in Treating Patients With Thyroid Cancer, Head and Neck Cancer, or Liver Metastases

This study has been completed.
Sponsor:
Information provided by:
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00062348
First received: June 5, 2003
Last updated: January 19, 2012
Last verified: January 2012

June 5, 2003
January 19, 2012
April 2003
December 2007   (final data collection date for primary outcome measure)
Boron uptake ratio in tumor vs normal tissue [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00062348 on ClinicalTrials.gov Archive Site
Toxicity measured by NCI-CTC v2.0 up to 28 days after injections [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Boronophenylalanine-Fructose Complex (BPA-F) and/or Sodium Borocaptate (BSH) Followed By Surgery in Treating Patients With Thyroid Cancer, Head and Neck Cancer, or Liver Metastases
B-Uptake In Different Tumours Using The Boron Compounds BSH And BPA

RATIONALE: Diagnostic procedures using boronophenylalanine-fructose complex (BPA-F) and/or sodium borocaptate (BSH) to detect the presence of boron in tumor cells may help determine whether patients who have thyroid cancer, head and neck cancer, or liver metastases may benefit from boron neutron capture therapy.

PURPOSE: This phase I trial is studying the side effects of giving BPA-F and/or BSH before surgery to detect boron uptake in tissues of patients with primary, metastatic, or recurrent thyroid cancer, head and neck cancer, or liver metastases from colorectal cancer.

OBJECTIVES:

  • Identify additional solid tumors that may benefit from boron neutron capture therapy.
  • Determine the boron concentration in the tumor, surrounding tissues, and blood of patients with operable thyroid cancer, squamous cell cancer of the head and neck, or liver metastases secondary to colorectal adenocarcinoma who receive boronophenylalanine-fructose complex (BPA-F) and/or sodium borocaptate (BSH) before surgical resection.
  • Determine the feasibility of using these drugs to obtain a favorable absolute boron-10 concentration in the tumor and optimal tumor-to-blood and tumor-to-healthy tissue boron-10 rates in these patients.
  • Determine the qualitative and quantitative toxicity of combined BPA-F and BSH administration in these patients.

OUTLINE: This is a multicenter study. Patients are sequentially assigned to 1 of 3 treatment groups.

  • Group I: Patients receive boronophenylalanine-fructose complex (BPA-F) IV over 1 hour. Two hours later, patients undergo surgical resection.
  • Group II: Patients receive sodium borocaptate (BSH) IV over 1 hour. Twelve hours later, patients undergo surgical resection.
  • Group III: Patients receive BSH IV over 1 hour (administered 12 hours prior to surgery) and BPA-F IV over 1 hour (administered 2 hours prior to surgery). Patients then undergo surgical resection.

During the planned surgery, tissue samples from the tumor and surrounding tissues are collected.

Patients are followed on days 1 and 5 and then at 4 weeks.

PROJECTED ACCRUAL: A maximum of 27 patients will be accrued for this study.

Interventional
Phase 1
Masking: Open Label
Primary Purpose: Treatment
  • Colorectal Cancer
  • Head and Neck Cancer
  • Metastatic Cancer
  • Drug: boronophenylalanine-fructose complex
  • Drug: sodium borocaptate
  • Procedure: conventional surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
Not Provided
December 2007   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed solid tumor of 1 of the following malignant tumor types:

    • Squamous cell cancer of the head and neck
    • Thyroid cancer
    • Liver metastases* secondary to colorectal adenocarcinoma NOTE: *Liver metastases are eligible provided colorectal adenocarcinoma has been histopathologically proven and CT scan/MRI shows metastatic lesions in the liver
  • Operable disease for which a surgical excision is planned
  • Primary, metastatic, or locally recurrent disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Neutrophil count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic

  • Bilirubin no greater than 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN
  • AST and ALT no greater than 2.5 times ULN
  • No other severe liver function impairment

Renal

  • Creatinine normal
  • BUN normal

Cardiovascular

  • No congestive heart failure
  • No angina pectoris
  • No recent coronary artery disease
  • No uncontrolled arrhythmias
  • No conduction defects
  • No other severe heart disease

Pulmonary

  • No severe obstructive or restrictive lung disease

Gastrointestinal

  • No severe gastrointestinal disease
  • No active peptic ulcer disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No pre-existing serious mental or organic brain disease (e.g., epilepsy)
  • No history of phenylketonuria (only in the case of BPA administration)
  • No severe allergic disease requiring continuous medication
  • No other concurrent severe disease
  • No uncontrolled endocrine disease
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • More than 3 months since prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to the malignant site

Surgery

  • See Disease Characteristics

Other

  • Recovered from prior antitumor therapy (excluding alopecia)
  • No concurrent anticancer treatment or agents
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00062348
EORTC-11001, EORTC-11001
Not Provided
Not Provided
European Organisation for Research and Treatment of Cancer - EORTC
Not Provided
Study Chair: Wolfgang Sauerwein, MD, PhD Universitaetsklinikum Essen
European Organisation for Research and Treatment of Cancer - EORTC
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP