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

NCT ID: NCT01967927

Last Updated: 2021-08-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2021-08-17

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

GRID 18F-MISO

Group Type: EXPERIMENTAL

18F-MISO

Intervention Type: DRUG

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

Interventions

18F-MISO

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

Intervention Type: DRUG

Other Intervention Names

[18F]FMISO; [18F]FLUOROMISONIDAZOLE; 1H-1-(3-[18F]-FLUORO-2-HYDROXY-PROPYL)-2-NITRO-IMIDAZOLE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert J Griffin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

138725

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

138725

Identifier Type: -

Identifier Source: org_study_id