Phase I Clinical Trial of Hyperbaric Oxygen Combined With Radiation and Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
18 Years
70 Years
Both
Carcinoma, Squamous Cell, Cancer of the Head and Neck
Trial Information
Phase I Clinical Trial of Hyperbaric Oxygen Combined With Radiation and Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
The goal of this study is to see if patients can tolerate HBO therapy up to five days a
week.
Three patients in Arm 1 (HBO on Monday and Friday) will be observed throughout their course
of concomitant radiation, chemo and hyperbaric therapy. If these patients appear to
tolerate this protocol well, and no adverse effects that can be directly attributed to HBO
are observed, then three more patients will be recruited for Arm 2 (HBO on Monday,
Wednesday, and Friday). If again these patients appear to tolerate this protocol well, and
no adverse effects that can be directly attributed to HBO are observed, then a third group
of three patients will be recruited for Arm 3 (HBO Monday through Friday).
If Grade IV acute toxicity is reported for a single patient in any of the arms, 3 more
patients will be recruited in the same arm. If no further adverse events occur, the protocol
progresses to the next arm. If Grade IV acute toxicity is observed even a single patient,
the study will be stopped.
Tumor and/or lymphatic tissue specimens will be obtained prior to starting treatment. Tumor
tissue specimens will be analyzed to determine whether there is a predictive susceptibility
of tumors to HBO sensitization using currently defined biomarkers known to correlate with
survival.
Inclusion Criteria:
- Patients with histological proof (from the primary lesion and/or lymph nodes) of
squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx.
- Patients should have Stage III or IV disease, M0
- Patients must have life expectancy of at least 6 months and a Karnofsky performance
status of ≥ 70
- Age ≥ 18 years and ≤ 70 years
- No distant metastatic disease
- No clinically significant heart disease:
- No significant ventricular arrhythmia requiring medication with antiarrhythmics
- No symptomatic coronary artery disease (angina)
- No myocardial infarction within the last 6 months
- No second or third degree heart block or bundle branch block or clinically
significant conduction system abnormality
- Patients must sign a study-specific informed consent form
Exclusion Criteria:
- Histology other than squamous cell carcinoma
- Evidence of metastasis (below the clavicle or distant) by clinical or radiographic
means
- Prior complete resection of the primary tumor
- Prior chemotherapy (Bleomycin) for head and neck cancer or radiotherapy to the head
and neck
- Patients with simultaneous primaries
- Pregnancy
- Pulmonary pathologies (risk of decompression-induced pulmonary barotrauma):
- Current, untreated pneumothorax
- Previous history of pneumothorax
- Previous history of intrathoracic surgery
- History of pulmonary blebs or bullous lung disease
- Associated with CO2 retention
- Poorly controlled or associated with acute bronchospasm
- Where the hyperbaric physician deems the patient to have an unacceptable risk for
hyperbaric treatments
- Claustrophobia
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Patient tolerance to each arm of the study
Outcome Time Frame:
During intervention phase
Safety Issue:
No
Principal Investigator
Dick Clarke, CHT
Investigator Role:
Study Director
Investigator Affiliation:
The Baromedical Research Foundation
Authority:
United States: Institutional Review Board
Study ID:
BRF 06-01
NCT ID:
NCT00474825
Start Date:
July 2007
Completion Date:
February 2011
Related Keywords:
- Carcinoma, Squamous Cell
- Cancer of the Head and Neck
- Carcinoma
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
Name | Location |
|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
| The Mayo Clinic | Rochester, Minnesota 55905 |
| Norfolk General Hospital / Eastern Virginia Medical School | Norfolk, Virginia 23507 |
