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

NCT01967927 | Withdrawn Early Phase 1 DMC

• 1 other identifier: 138725
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Keywords

carcinoma; cancer; head; neck; otolaryngology

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

GRID 18F-MISO

EXPERIMENTAL

Drug: 18F-MISO

Interventions

18F-MISO DRUG

A radiolabeled imaging agent that has been used for investigating tumor hypoxia with positron emission tomography (PET).

Also known as: [18F]FMISO, [18F]FLUOROMISONIDAZOLE, 1H-1-(3-[18F]-FLUORO-2-HYDROXY-PROPYL)-2-NITRO-IMIDAZOLE

GRID 18F-MISO

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Leukocytes ≥ 3000/uL
• ANC ≥ 1500/uL
• Platelets ≥ 100000/UI
• Serum Creatinine ≤ 2.0 mg/dL

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72120, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma; Neoplasms

Interventions

fluoromisonidazole

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Robert J Griffin, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 23, 2013
• Study Start: December 1, 2013
• Primary Completion: August 17, 2021
• Study Completion: August 17, 2021
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

US (1)