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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 Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about 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 conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. 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 Clinical research trials and 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 health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as 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. 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 Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a 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 clinical trial. Human subjects frequently get the finest healthcare available for their 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 condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > 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  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
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
For Condition: Gastrointestinal Cancer,Head and Neck Cancer,metastatic cancer,Endocrine Cancer
Status: Recruiting
Sponsor(s): EORTC Boron Neutron Capture Therapy Study Group ,
Synopsis: 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: Phase I trial to study the effectiveness of BPA-F and/or BSH followed by surgery in detecting boron uptake in tissues of patients who have primary, metastatic, or recurrent thyroid cancer, head and neck cancer, or who have liver metastases from colorectal cancer.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WolfgangSauerwein, , Universitaetsklinikum Essen
Universitaetsklinikum Essen *Recruiting*
ESSEN, , D-45122
Germany
Recruiting Contact Person 49-201-72-311
Additional Information:
Study ID Numbers: CDR0000304732; EORTC-11001
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062348
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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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