Clinical trial of Fluosol DA 20% in advanced squamous cell carcinoma of the head and neck
Fluosol DA 20% (Fluosol) enhances the response of several rodent tumors to radiation and oxygen. This is a Phase I/II study of Fluosol and oxygen breathing in the radiation treatment of advanced squamous cell carcinoma of the head and neck. Fifteen patients with Stage III/IV tumors entered and completed this trial. Patients received 1.8 Gy/fraction to 45 Gy, at which time the spinal cord was shielded and gross disease was carried to 68-72 Gy. 8 ml/kg (11 patients) or 9 ml/kg (4 patients) Fluosol was infused prior to the first fraction each week for the first 5 weeks. All patients inspired 100% oxygen before and during the initial 25 fractions. The infusions were well-tolerated. Four acute reactions that responded to diphenhydramine or steroids were observed in the 75 infusions. 8/15 patients exhibited liver function abnormalities of 2-3X normal which fell after therapy was discontinued. Normal mucosal reactions were enhanced despite the 1.8 Gy fraction size. 10/15 patients required at least one treatment break: the mean dose achieved before the break was 35 Gy. Tumor clearance was also accelerated. Thirteen patients had primary tumor clearance, but one had a local recurrence. Ten had primary and nodal clearance and 2/3 with nodal persistence had salvage surgery with fibrosis only at pathologic review. One patient, locally controlled, developed distant metastases. Thus, 10/15 patients are NED, but followup time is short.
- Research Organization:
- St. Joseph Medical Center, Burbank, CA
- OSTI ID:
- 6847203
- Journal Information:
- Int. J. Radiat. Oncol., Biol. Phys.; (United States), Vol. 8
- Country of Publication:
- United States
- Language:
- English
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Related Subjects
62 RADIOLOGY AND NUCLEAR MEDICINE
CARCINOMAS
RADIOTHERAPY
RADIOSENSITIZERS
TESTING
HEAD
INHALATION
MICE
NECK
OXYGEN
PATIENTS
SURVIVAL TIME
ANIMALS
BODY
BODY AREAS
DISEASES
DRUGS
ELEMENTS
INTAKE
MAMMALS
MEDICINE
NEOPLASMS
NONMETALS
NUCLEAR MEDICINE
RADIOLOGY
RODENTS
THERAPY
VERTEBRATES
560151* - Radiation Effects on Animals- Man
550603 - Medicine- External Radiation in Therapy- (1980-)