Understanding GRID Radiation Therapy Effects on Human Tumor Oxygenation and Interstitial Pressure to Increase Translation of Solid Tumor Therapy

Squamous Cell Carcinoma of the Head and Neck Clinical Trial

Official title:

Understanding GRID Radiation Therapy Effects on Human Tumor Oxygenation and Interstitial Pressure to Increase Translation of Solid Tumor Therapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01967927
• Other study ID #: 138725
• Secondary ID: 138725
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: December 2013
• Est. completion date: August 17, 2021

Study information

• Verified date: August 2021
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 17, 2021
• Est. primary completion date: August 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma of the Head and Neck

Intervention

Drug:
• 18F-MISO
A radiolabeled imaging agent that has been used for investigating tumor hypoxia with positron emission tomography (PET).

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the mean and standard deviation of the decrease in interstitial fluid pressure in tumors within 72 hours after GRID treatment.		within 72 hours after GRID treatment