search
Back to results

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

Primary Purpose

Squamous Cell Carcinoma of the Head and Neck

Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-MISO
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Squamous Cell Carcinoma of the Head and Neck focused on measuring carcinoma, cancer, head, neck, otolaryngology

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GRID 18F-MISO

Arm Description

Outcomes

Primary Outcome Measures

To estimate the mean and standard deviation of the decrease in interstitial fluid pressure in tumors within 72 hours after GRID treatment.

Secondary Outcome Measures

Full Information

First Posted
October 18, 2013
Last Updated
August 17, 2021
Sponsor
University of Arkansas
search

1. Study Identification

Unique Protocol Identification Number
NCT01967927
Brief Title
Understanding GRID Radiation Therapy Effects on Human Tumor Oxygenation and Interstitial Pressure to Increase Translation of Solid Tumor Therapy
Official Title
Understanding GRID Radiation Therapy Effects on Human Tumor Oxygenation and Interstitial Pressure to Increase Translation of Solid Tumor Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Study has been open for 8 years with no enrollment. Procedures in 2013 protocol are outdated. Cannot make the radiopharmaceutical on campus anymore.
Study Start Date
December 2013 (undefined)
Primary Completion Date
August 17, 2021 (Actual)
Study Completion Date
August 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Head and Neck
Keywords
carcinoma, cancer, head, neck, otolaryngology

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
GRID 18F-MISO
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
18F-MISO
Other Intervention Name(s)
[18F]FMISO, [18F]FLUOROMISONIDAZOLE, 1H-1-(3-[18F]-FLUORO-2-HYDROXY-PROPYL)-2-NITRO-IMIDAZOLE
Intervention Description
A radiolabeled imaging agent that has been used for investigating tumor hypoxia with positron emission tomography (PET).
Primary Outcome Measure Information:
Title
To estimate the mean and standard deviation of the decrease in interstitial fluid pressure in tumors within 72 hours after GRID treatment.
Time Frame
within 72 hours after GRID treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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: Leukocytes ≥ 3000/uL ANC ≥ 1500/uL Platelets ≥ 100000/UI 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Griffin, PhD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72120
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs