Dose Escalation Study of Hyperbaric Oxygen With Radiation and Chemotherapy to Treat Squamous Cell Carcinoma of the Head and Neck - Full Text View

Sponsors and Collaborators:	Baromedical Research Foundation Palmetto Health Richland Mayo Clinic Dartmouth-Hitchcock Medical Center Eastern Virginia Medical School
Information provided by:	Baromedical Research Foundation
ClinicalTrials.gov Identifier:	NCT00474825

Purpose

This research is being done because we do not know the best treatment for advanced Squamous Cell Carcinoma of the Head and Neck. These cancers have been treated with a combination of surgery, radiation and chemotherapy in varying combination. When the tumor is inoperable, radiation therapy is used with or without chemotherapy in the hope of curing the tumor.

Recently, it has become recognized as generalized knowledge that cancer cells are hypoxic (low oxygen concentration). Because of the low oxygen concentrations, many cancer treatments have not been successful. The theory behind this study is to give oxygen to patients prior to chemotherapy and radiation in hopes of generating greater results in killing cancer cells. The purpose of this study has two main objectives. The primary objective is to determine patient tolerance to each arm of the trial.

The second objective is to determine the feasibility of treatment delivery and acute toxicities associated with each regimen.

It is our intention to undertake a randomized and controlled trial should this Phase I trial prove successful in terms of patient tolerance.

Condition	Intervention	Phase
Carcinoma, Squamous Cell Cancer of the Head and Neck	Drug: Hyperbaric Oxygen Therapy Drug: Hyperbaric Oxygen Drug: Hyperbaric oxygen	Phase I

MedlinePlus related topics: Cancer Head and Neck Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase I Clinical Trial of Hyperbaric Oxygen Combined With Radiation and Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Further study details as provided by Baromedical Research Foundation:

Primary Outcome Measures:

Patient tolerance to each arm of the study [ Time Frame: During intervention phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Grade IV acute toxicities associated with each arm of the study [ Time Frame: During intervention phase ] [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Hyperbaric Oxygen twice weekly (Monday & Friday) with Radiation and Chemotherapy	Drug: Hyperbaric Oxygen Therapy Compression rate (breathing oxygen): per patient tolerance; 1 - 3 psi per minute Treatment dose: 2.4 ATA oxygen Treatment period: 30 minutes at 2.4 ATA Decompression rate (breathing oxygen): 2 - 3 psi per minute Drug: Hyperbaric Oxygen Compression rate (breathing oxygen): per patient tolerance; 1 - 3 psi per minute Treatment dose: 2.4 ATA oxygen Treatment period: 30 minutes at 2.4 ATA Decompression rate (breathing oxygen): 2 - 3 psi per minute
2: Active Comparator Hyperbaric Oxygen three times per week (Monday, Wednesday & Friday) with Radiation and Chemotherapy.	Drug: Hyperbaric Oxygen Therapy Compression rate (breathing oxygen): per patient tolerance; 1 - 3 psi per minute Treatment dose: 2.4 ATA oxygen Treatment period: 30 minutes at 2.4 ATA Decompression rate (breathing oxygen): 2 - 3 psi per minute Drug: Hyperbaric oxygen Compression rate (breathing oxygen): per patient tolerance; 1 - 3 psi per minute Treatment dose: 2.4 ATA oxygen Treatment period: 30 minutes at 2.4 ATA Decompression rate (breathing oxygen): 2 - 3 psi per minute
3: Active Comparator Hyperbaric Oxygen Five times per week (Monday through Friday) with Radiation and Chemotherapy	Drug: Hyperbaric Oxygen Therapy Compression rate (breathing oxygen): per patient tolerance; 1 - 3 psi per minute Treatment dose: 2.4 ATA oxygen Treatment period: 30 minutes at 2.4 ATA Decompression rate (breathing oxygen): 2 - 3 psi per minute Drug: Hyperbaric oxygen Compression rate (breathing oxygen): per patient tolerance; 1 - 3 psi per minute Treatment dose: 2.4 ATA oxygen Treatment period: 30 minutes at 2.4 ATA Decompression rate (breathing oxygen): 2 - 3 psi per minute

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474825

Contacts

Contact: Dick Clarke, CHT	803-434-7101	dick.clarke@palmettohealth.org
Contact: Samir Desai, MHA	803-434-7101	samir.desai@palmettohealth.org

Locations

United States, Minnesota
The Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Robert Foote, MD
United States, New Hampshire
Dartmouth-Hitchcock Medical Center	Recruiting
Lebanon, New Hampshire, United States, 03756
Principal Investigator: Jay Buckey, MD
Principal Investigator: Gabrielle Popp, MD
United States, Virginia
Norfolk General Hospital / Eastern Virginia Medical School	Recruiting
Norfolk, Virginia, United States, 23507
Principal Investigator: Surjeet S Pohar, MD

Sponsors and Collaborators

Baromedical Research Foundation

Palmetto Health Richland

Mayo Clinic

Dartmouth-Hitchcock Medical Center

Eastern Virginia Medical School

Investigators

Study Director:	Dick Clarke, CHT	The Baromedical Research Foundation
Principal Investigator:	Surjeet S Pohar, MD	Eastern Virginia Medical School / Norfolk General Hospital
Principal Investigator:	Jay Buckey, MD	Dartmouth-Hitchcock Medical Center
Principal Investigator:	Robert Foote, MD	The Mayo Clinic

More Information

Responsible Party:	The Baromedical Research Foundation ( Director )
Study ID Numbers:	BRF 06-01, ISRCTN12244200
Study First Received:	May 16, 2007
Last Updated:	January 4, 2008
ClinicalTrials.gov Identifier:	NCT00474825
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Epidermoid carcinoma
Squamous cell carcinoma
Head and Neck Neoplasms
Carcinoma, squamous cell
Neoplasms, Squamous Cell

Carcinoma, Squamous Cell
Carcinoma, squamous cell of head and neck
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009