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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

Primary Purpose

Colorectal Cancer, Head and Neck Cancer, Metastatic Cancer

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
boronophenylalanine-fructose complex
sodium borocaptate
conventional surgery
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 Colorectal Cancer focused on measuring recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, untreated metastatic squamous neck cancer with occult primary, recurrent thyroid cancer, stage IV follicular thyroid cancer, stage IV papillary thyroid cancer, stage IVA colon cancer, stage IVB colon cancer, recurrent colon cancer, adenocarcinoma of the colon, recurrent rectal cancer, stage IVA rectal cancer, stage IVB rectal cancer, adenocarcinoma of the rectum, anaplastic thyroid cancer, insular thyroid cancer, thyroid gland medullary carcinoma, liver metastases, stage I squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the lip and oral cavity, stage I squamous cell carcinoma of the nasopharynx, stage I squamous cell carcinoma of the oropharynx, stage I squamous cell carcinoma of the paranasal sinus and nasal cavity, stage II squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the nasopharynx, stage II squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the paranasal sinus and nasal cavity, stage III squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage I papillary thyroid cancer, stage II papillary thyroid cancer, stage III papillary thyroid cancer, stage I follicular thyroid cancer, stage II follicular thyroid cancer, stage III follicular thyroid cancer, recurrent metastatic squamous neck cancer with occult primary, recurrent salivary gland cancer, salivary gland squamous cell carcinoma, stage I salivary gland cancer, stage II salivary gland cancer, stage III salivary gland cancer, stage IV salivary gland cancer, tongue cancer

Eligibility Criteria

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

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

Sites / Locations

  • Universitaetsklinikum Essen

Outcomes

Primary Outcome Measures

Boron uptake ratio in tumor vs normal tissue

Secondary Outcome Measures

Toxicity measured by NCI-CTC v2.0 up to 28 days after injections

Full Information

First Posted
June 5, 2003
Last Updated
January 19, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00062348
Brief Title
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
Official Title
B-Uptake In Different Tumours Using The Boron Compounds BSH And BPA
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Head and Neck Cancer, Metastatic Cancer
Keywords
recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, untreated metastatic squamous neck cancer with occult primary, recurrent thyroid cancer, stage IV follicular thyroid cancer, stage IV papillary thyroid cancer, stage IVA colon cancer, stage IVB colon cancer, recurrent colon cancer, adenocarcinoma of the colon, recurrent rectal cancer, stage IVA rectal cancer, stage IVB rectal cancer, adenocarcinoma of the rectum, anaplastic thyroid cancer, insular thyroid cancer, thyroid gland medullary carcinoma, liver metastases, stage I squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the lip and oral cavity, stage I squamous cell carcinoma of the nasopharynx, stage I squamous cell carcinoma of the oropharynx, stage I squamous cell carcinoma of the paranasal sinus and nasal cavity, stage II squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the nasopharynx, stage II squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the paranasal sinus and nasal cavity, stage III squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage I papillary thyroid cancer, stage II papillary thyroid cancer, stage III papillary thyroid cancer, stage I follicular thyroid cancer, stage II follicular thyroid cancer, stage III follicular thyroid cancer, recurrent metastatic squamous neck cancer with occult primary, recurrent salivary gland cancer, salivary gland squamous cell carcinoma, stage I salivary gland cancer, stage II salivary gland cancer, stage III salivary gland cancer, stage IV salivary gland cancer, tongue cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
boronophenylalanine-fructose complex
Intervention Type
Drug
Intervention Name(s)
sodium borocaptate
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Primary Outcome Measure Information:
Title
Boron uptake ratio in tumor vs normal tissue
Secondary Outcome Measure Information:
Title
Toxicity measured by NCI-CTC v2.0 up to 28 days after injections

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Sauerwein, MD, PhD
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
21367608
Citation
Wittig A, Sheu-Grabellus SY, Collette L, Moss R, Brualla L, Sauerwein W. BPA uptake does not correlate with LAT1 and Ki67 expressions in tumor samples (results of EORTC trial 11001). Appl Radiat Isot. 2011 Dec;69(12):1807-12. doi: 10.1016/j.apradiso.2011.02.018. Epub 2011 Feb 16.
Results Reference
result
PubMed Identifier
19735988
Citation
Bendel P, Wittig A, Basilico F, Mauri PL, Sauerwein W. Metabolism of borono-phenylalanine-fructose complex (BPA-fr) and borocaptate sodium (BSH) in cancer patients--results from EORTC trial 11001. J Pharm Biomed Anal. 2010 Jan 5;51(1):284-7. doi: 10.1016/j.jpba.2009.08.018. Epub 2009 Aug 22.
Results Reference
result
PubMed Identifier
19602035
Citation
Wittig A, Collette L, Appelman K, Buhrmann S, Jackel MC, Jockel KH, Schmid KW, Ortmann U, Moss R, Sauerwein WAG. EORTC trial 11001: distribution of two 10B-compounds in patients with squamous cell carcinoma of head and neck, a translational research/phase 1 trial. J Cell Mol Med. 2009 Aug;13(8B):1653-1665. doi: 10.1111/j.1582-4934.2009.00856.x. Epub 2009 Jul 10.
Results Reference
result
PubMed Identifier
19372041
Citation
Wittig A, Collette L, Moss R, Sauerwein WA. Early clinical trial concept for boron neutron capture therapy: a critical assessment of the EORTC trial 11001. Appl Radiat Isot. 2009 Jul;67(7-8 Suppl):S59-62. doi: 10.1016/j.apradiso.2009.03.012. Epub 2009 Mar 25.
Results Reference
result
PubMed Identifier
17985341
Citation
Wittig A, Malago M, Collette L, Huiskamp R, Buhrmann S, Nievaart V, Kaiser GM, Jockel KH, Schmid KW, Ortmann U, Sauerwein WA. Uptake of two 10B-compounds in liver metastases of colorectal adenocarcinoma for extracorporeal irradiation with boron neutron capture therapy (EORTC Trial 11001). Int J Cancer. 2008 Mar 1;122(5):1164-71. doi: 10.1002/ijc.23224.
Results Reference
result

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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

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