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Purpose

To estimate the mean and standard deviation (SD) of the post-treatment decreases in the interstitial fluid pressure and hypoxia-specific PET-scan signal from GRID-treated tumors in patients with locally advanced squamous-cell carcinoma of the head and neck. The possible effects of GRID radiotherapy on tumor oxygenation levels and interstitial fluid pressure within the tumors will be measured by assessing the trend and statistical significance of the difference in values for each condition obtained prior to and just after GRID exposure in each subject enrolled in the study. We expect that there may be a trend for increases in tumor oxygenation and decreases in interstitial fluid pressure which would indicate that more accurately timed additional chemotherapy and radiation therapy would improve overall patient outcomes.

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 18 - 80 years of age - Karnofsky performance status greater than 70 or ECOG ≥ 2 - Cytological or histological documentation of squamous cell carcinoma of the head and neck, including the tongue, with a minimum tumor size of 6cm in any dimension. - History of adequate hepatic function (endoscopic or percutaneous drainage as needed): a. AST (SGOT) / ALT (SGPT) ≤ 5X institutional ULN - Chemotherapy naive - History of adequate renal and bone marrow function: 1. Leukocytes ≥ 3000/uL 2. ANC ≥ 1500/uL 3. Platelets ≥ 100000/UI 4. Serum Creatinine ≤ 2.0 mg/dL

Exclusion Criteria

  • Women with a positive urine pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence - Subjects with active infections such as pneumonia, or wound infections that would preclude study procedures - Subjects with known presence of central nervous system or brain metastases - Subjects with prior radiotherapy to the head and neck region - Subjects will be excluded if deemed unable to comply with study procedures

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
GRID 18F-MISO
  • Drug: 18F-MISO
    A radiolabeled imaging agent that has been used for investigating tumor hypoxia with positron emission tomography (PET).
    Other names:
    • [18F]FMISO
    • [18F]FLUOROMISONIDAZOLE
    • 1H-1-(3-[18F]-FLUORO-2-HYDROXY-PROPYL)-2-NITRO-IMIDAZOLE

Recruiting Locations

More Details

NCT ID
NCT01967927
Status
Withdrawn
Sponsor
University of Arkansas

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.