Study to Calculate the Radiation Dosimetry in Subjects With Head and Neck Cancer

Completed

Conditions studied: Head and Neck Cancer

In brief

Preliminary observations suggest positron emission tomography (PET) imaging with an F-18 labeled thymidine analog (FLT) can selectively identify proliferating and non-proliferating tissues, including tumors. FLT uptake in the tumor appears to reflect the level of cells undergoing DNA synthesis. This is clinically important because cell proliferation markers have significant prognostic value, both prior to initiating radiotherapy and as they change during the course of therapy. In the proposed study, the researchers assess the biodistribution and radiation dosimetry of FLT to obtain the necessary data to file an Investigational New Drug (IND) application with the Food and Drug Administration (FDA). The information collected under Radioactive Drug Research Committee (RDRC) approval will not be used for diagnostic purposes, to assess the subject's response to therapy, or for clinical management of the subject.

Key facts

Study ID: NCT00245349
Run by: University of Iowa
People needed: 9
Starts: 2005-10-01
Expected to finish: 2008-04-01
Last updated by the study team: 2008-06-10

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Ability to understand and willingness to sign a written informed consent document.
Subject must have histologically confirmed stage III, or IV squamous cell carcinoma of the head and neck whose primary origin was from the oral cavity, oropharynx, hypopharynx, or larynx. Carcinoma must be staged using the American Joint Committee on Cancer (AJCC) staging criteria version 6. Adequate tumor must be amenable to biopsy via outpatient methods, therefore the majority of subjects will be those with oropharyngeal lesions.
Subjects must be scheduled to receive combined chemo-radiotherapy treatment for their standard cancer care. Treatment decisions will be made by the treating otolaryngologist, radiation, and medical oncologists.
Males or females greater than or equal to 21 years of age. Squamous cell cancer of the head and neck is exceedingly rare in children and not generally applicable to the pediatric population.
Karnofsky score greater than or equal to 60% at time of screening.
Life expectancy of greater than 6 months.
Subject must have normal organ and marrow function as defined below:
leukocytes greater than or equal to 3,000/microL
absolute neutrophil count greater than or equal to 1,500/microL
platelets greater than or equal to 100,000/microL
total bilirubin within normal institutional limits
AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal
creatinine within normal institutional limits
BUN within normal institutional limits
PT and PTT < 2.0 X upper normal limits
The effects of FLT on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A screening urine hCG will be administered to women of childbearing potential before each FLT scan.

You may not qualify if…

Subjects who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Subject may not be receiving any other investigational agents.
Subject with a Karnofsky score below 60.
Pregnant women are excluded from this study. FLT PET has the potential for teratogenic effects. Because there are potentially unknown risks for adverse events in nursing infants secondary to treatment of the mother with FLT, breastfeeding should be discontinued if the mother is imaged with FLT and may not resume for 48 hours after the FLT imaging.
Subject with an inadequate marrow reserve as determined by history and/or the above tests.
Subject with a bleeding or clotting dysfunction as determined by medical history and above tests.
Subjects taking nucleoside analog medications such as those used as antiretroviral agents.
Inadequate tumor volume to allow for 2 biopsies.

Where it is running

University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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