NCT00062348

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2003

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Last Updated

January 20, 2012

Status Verified

January 1, 2012

Enrollment Period

4.7 years

First QC Date

June 5, 2003

Last Update Submit

January 19, 2012

Conditions

Colorectal CancerHead and Neck CancerMetastatic Cancer

Keywords

recurrent squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the larynxrecurrent squamous cell carcinoma of the lip and oral cavityrecurrent squamous cell carcinoma of the nasopharynxrecurrent squamous cell carcinoma of the oropharynxrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavitystage IV squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the larynxstage IV squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the nasopharynxstage IV squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the paranasal sinus and nasal cavityuntreated metastatic squamous neck cancer with occult primaryrecurrent thyroid cancerstage IV follicular thyroid cancerstage IV papillary thyroid cancerstage IVA colon cancerstage IVB colon cancerrecurrent colon canceradenocarcinoma of the colonrecurrent rectal cancerstage IVA rectal cancerstage IVB rectal canceradenocarcinoma of the rectumanaplastic thyroid cancerinsular thyroid cancerthyroid gland medullary carcinomaliver metastasesstage I squamous cell carcinoma of the hypopharynxstage I squamous cell carcinoma of the larynxstage I squamous cell carcinoma of the lip and oral cavitystage I squamous cell carcinoma of the nasopharynxstage I squamous cell carcinoma of the oropharynxstage I squamous cell carcinoma of the paranasal sinus and nasal cavitystage II squamous cell carcinoma of the hypopharynxstage II squamous cell carcinoma of the larynxstage II squamous cell carcinoma of the lip and oral cavitystage II squamous cell carcinoma of the nasopharynxstage II squamous cell carcinoma of the oropharynxstage II squamous cell carcinoma of the paranasal sinus and nasal cavitystage III squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the larynxstage III squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the nasopharynxstage III squamous cell carcinoma of the oropharynxstage III squamous cell carcinoma of the paranasal sinus and nasal cavitystage I papillary thyroid cancerstage II papillary thyroid cancerstage III papillary thyroid cancerstage I follicular thyroid cancerstage II follicular thyroid cancerstage III follicular thyroid cancerrecurrent metastatic squamous neck cancer with occult primaryrecurrent salivary gland cancersalivary gland squamous cell carcinomastage I salivary gland cancerstage II salivary gland cancerstage III salivary gland cancerstage IV salivary gland cancertongue cancer

Outcome Measures

Primary Outcomes (1)

  • Boron uptake ratio in tumor vs normal tissue

Secondary Outcomes (1)

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

Interventions

boronophenylalanine-fructose complexDRUG
sodium borocaptateDRUG
conventional surgeryPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

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

Sponsors & Collaborators

Study Sites (1)

Universitaetsklinikum Essen

Essen, D-45122, Germany

Location

Related Publications (5)

  • 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.

    PMID: 21367608RESULT

  • 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.

    PMID: 19735988RESULT

  • 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.

    PMID: 19602035RESULT

  • 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.

    PMID: 19372041RESULT

  • 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.

    PMID: 17985341RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsHead and Neck NeoplasmsNeoplasm MetastasisSquamous Cell Carcinoma of Head and NeckThyroid NeoplasmsAdenocarcinoma, FollicularThyroid Cancer, PapillaryColonic NeoplasmsRectal NeoplasmsThyroid Carcinoma, AnaplasticCarcinoma, MedullarySalivary Gland NeoplasmsTongue Neoplasms

Interventions

4-boronophenylalanine-fructosemercaptoundecahydrododecaborate

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeEndocrine Gland NeoplasmsEndocrine System DiseasesThyroid DiseasesAdenocarcinomaAdenocarcinoma, PapillaryCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve TissueMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland DiseasesTongue Diseases

Study Officials

  • Wolfgang Sauerwein, MD, PhD

    Universitaetsklinikum Essen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NETWORK

Study Record Dates

First Submitted

June 5, 2003

First Posted

June 6, 2003

Study Start

April 1, 2003

Primary Completion

December 1, 2007

Last Updated

January 20, 2012

Record last verified: 2012-01

Locations

DE(1)