Clinical trial NCT01967927: 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
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Squamous Cell Carcinoma of the Head and Neck
Keywords: carcinoma
cancer
head
neck
otolaryngology
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2013-10-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: To estimate the mean and standard deviation of the decrease in interstitial fluid pressure in tumors within 72 hours after GRID treatment.
timeFrame: within 72 hours after GRID treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Robert J Griffin, PhD
role: PRINCIPAL_INVESTIGATOR
References: