ADXS 11-001 Vaccination Prior to Robotic Surgery, HPV-Positive Oropharyngeal Cancer

• Sponsor: Andrew Sikora (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02002182
• Collaborator: Advaxis, Inc. (Industry)
• Enrollment: 15
• Locations: 2
• Arms: 2
• Duration (Months): 116
• Patients Per Site: 7.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Some cancers may be related to an infection with a virus, such as the Human Papilloma Virus (HPV). HPV related Oropharyngeal cancer (HPVOPC) accounts for 80% of oropharynx cancer cases in the United States. HPVOPC has better prognosis than patients with HPV negative oropharynx cancer. In many hospitals, the standard of care treatment for oropharyngeal cancer is surgery and/or radiotherapy with or without chemotherapy. While chances of survival for most patients with HPVOPC is very good, current treatments are associated with short- and long-term side effects which can be severe. In pre-clinical research using animal models of cancer, vaccination targeting the HPV virus has been found to cause tumor regression. Thus, approaches which target the unique characteristics of HPV-infected cancer cells, such as therapeutic vaccination, are attractive strategies for potentially reducing radiotherapy and chemo radiotherapy regimens (and thus decreasing toxicity) and enhancing long-term disease control.

The purpose of this study is to see if an experimental vaccine, ADXS11-001, is effective in stimulating the body's defense system against HPV-positive oropharyngeal squamous cell carcinoma before transoral (through the mouth) surgery. The experimental product ADXS11-001 uses a live strain of the Listeria monocytogenes (Lm) bacteria that has been genetically modified such that the risk of getting an infection is significantly reduced. Several research studies have already been conducted with ADXS11-001 in men and women with cancer. So far, approximately 722 doses of ADXS11-001 have been given to 290 patients with HPV associated cancers.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer; Squamous Cell Carcinoma of the Head and Neck; HPV Positive Oropharyngeal Squamous Cell Carcinoma	Biological: ADXS11-001 (ADXS-HPV)	Phase 2

Detailed Description

This is an investigator-initiated prospective clinical study of patients with stage I-IV squamous cell carcinoma of the oropharynx (OPSCC) who are to undergo ablative transoral robotic surgery (TORS).

There is a vaccination group and a control group in this study.

Subjects in the control group will not receive the vaccination and will only be followed after TORS surgery for additional research blood tests to measure how their immune system is working.

Subjects in the vaccination group will receive two vaccinations prior to surgery. The first dose will be about 33 days before surgery, and the second will be about 14 days before surgery.

Participation in this study will also include allowing the research team to take several blood samples from the subject at various times before, during, and after treatment for his/her cancer.

Vaccination subjects will be monitored closely after treatment and includes 6 months of oral antibiotics.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Window of Opportunity Trial of Neoadjuvant ADXS 11-001 Vaccination Prior to Robot -Assisted Resection of HPV-Positive Oropharyngeal Squamous Cell Carcinoma
• Study Start Date: Dec 1, 2013
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment-Vaccine Group Two vaccinations with ADXS11-001 (ADXS-HPV) will be given at a dose of 1x10^9 cfu intravenously. The drug will be given as a 500ml infusion over 60 minutes.	Biological: ADXS11-001 (ADXS-HPV); ADXS11-001 (ADXS-HPV) is a live attenuated Listeria monocytogenes (Lm)-LLO immunotherapy developed for the treatment of HPV-associated dysplasia and malignancy.; Other Names: ADXS11-001 ADXS-HPV
No Intervention: Control Group Observational control group treated with standard of care therapy only

Outcome Measures

Primary Outcome Measures

1. HPV-Specific T Cell Response Rate [At time of surgery]

   Response rate defined as proportion of participants with a >2-fold increase in HPV-specific T cell response from baseline to time of surgery.

2. Number of Participants With Any Grade 3 or 4 Toxicity [Assessed up to 30 Days after surgery]

   Degree of toxicity assessed according to NCI Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria.

Secondary Outcome Measures

1. HPV-Specific T Cell Response Rate [Assessed up to 3 months after surgery]

   Response rate defined as proportion of participants with a >2-fold increase in HPV-specific T cell response from baseline to 3 months after surgery.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The patient has newly-diagnosed, biopsy proven squamous cell carcinoma of Stage I-IV (T1-3, N0-2b) of the oropharynx.

• The patient's tumor is HPV positive by PCR or ISH assay of tumor biopsy.

• The patient is able/eligible to undergo treatment with transoral robotic surgery (TORS) with or without neck dissection and with or without adjuvant radiation therapy or chemoradiation.

• The patient is able to understand and give informed consent.

• The patient is at least 18 years old.

• The patient's ECOG performance status is </= 2.

Exclusion Criteria:

• The patient has had prior head and neck squamous cell carcinoma (HNSCC), with the exception of superficial cutaneous basal cell or squamous cell carcinomas.

• The patient has active cancer in another part of the body, with the exception of superficial cutaneous basal cell or squamous cell carcinomas

• If a cancer survivor, the disease free interval is less than 3 years, with the exception of superficial cutaneous basal cell or squamous cell carcinomas.

• If a cancer survivor the patient received prior systemic chemotherapy or radiotherapy

• If prior standard-of-care pre-treatment biopsy is inadequate for analysis by immunohistochemistry, and the patient is unwilling to undergo an additional biopsy procedure.

• The patient is a prisoner.

• The patient has a psychiatric illness or developmental delay which would interfere with understanding of the study and provision of informed consent.

• The patient has previously received definitive surgical, radiation, or chemoradiation treatment for HNSCC.

• The patient has a history of HIV or other known cause of immunosuppression, or is actively taking immunosuppressive medications due to organ transplantation, rheumatoid disease, or other medical conditions.

• Patient is allergic to naproxen or Ibuprofen.

• The patient has a history of liver disease.

• The patient has a contraindication (e.g. sensitivity/allergy) to both trimethoprim/sulfamethoxazole and ampicillin.

• The patient has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)). NOTE: More common devices and prosthetics which include arterial and venous stents, dental and breast implants and venous access devices (e.g. Port-a-Cath or Mediport) are permitted.

• Patients who are receiving or may receive future treatment with PI3K or TNFα inhibitors.

• Patients who have undergone a major surgery, including surgery for a new artificial implant and/or device, within 6 weeks prior to the initiation of ADXS11-001 treatment. Sponsor must be consulted prior to enrolling subjects on the study who recently had a major surgery or have new artificial implant, and/or devices.

• Patients who have a history of listeriosis or prior ADXS11-001 therapy.

• Patients with a known allergy to any component of the study treatment formulations.

• Pregnancy. The effects of this vaccine on the developing human fetus are unknown. For this reason women of child-bearing potential and men must use two forms of contraception (i.e., barrier contraception and one other method of contraception) at least 4 weeks prior to study entry, for the duration of study participation, Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
2	Baylor College of Medicine	Houston	Texas	United States	77030

Sponsors and Collaborators

• Andrew Sikora
• Advaxis, Inc.

Investigators

• Study Chair: Andrew G Sikora, MD PhD, Baylor College of Medicine
• Principal Investigator: Brett Miles, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 9, 2020

More Information

Publications

None provided.

• Responsible Party: Andrew Sikora, Associate Professor, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT02002182
• Other Study ID Numbers: H-36001 GCO 13-1411
• First Posted: Dec 5, 2013
• Last Update Posted: Jul 2, 2021
• Last Verified: Jul 1, 2021

• Keywords provided by Andrew Sikora, Associate Professor, Baylor College of Medicine: HPV; oropharynx; squamous cell carcinoma; head and neck cancer; transoral robotic surgery
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Study Results

Participant Flow

Arm/Group Title	Treatment-Vaccine Group	Control Group
Arm/Group Description	Two vaccinations with ADXS11-001 (ADXS-HPV) will be given at a dose of 1x10^9 cfu intravenously. The drug will be given as a 500ml infusion over 60 minutes. ADXS11-001 (ADXS-HPV): ADXS11-001 (ADXS-HPV) is a live attenuated Listeria monocytogenes (Lm)-LLO immunotherapy developed for the treatment of HPV-associated dysplasia and malignancy.	Observational control group treated with standard of care therapy only
Period Title: Overall Study
STARTED	9	6
COMPLETED	4	5
NOT COMPLETED	5	1

Baseline Characteristics

Arm/Group Title	Treatment-Vaccine Group	Control Group	Total
Arm/Group Description	Two vaccinations with ADXS11-001 (ADXS-HPV) will be given at a dose of 1x10^9 cfu intravenously. The drug will be given as a 500ml infusion over 60 minutes. ADXS11-001 (ADXS-HPV): ADXS11-001 (ADXS-HPV) is a live attenuated Listeria monocytogenes (Lm)-LLO immunotherapy developed for the treatment of HPV-associated dysplasia and malignancy.	Observational control group treated with standard of care therapy only	Total of all reporting groups
Overall Participants	9	6	15
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	72	53	62
Sex: Female, Male (Count of Participants)
Female	2 22.2%	1 16.7%	3 20%
Male	7 77.8%	5 83.3%	12 80%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	7 77.8%	6 100%	13 86.7%
Unknown or Not Reported	2 22.2%	0 0%	2 13.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 11.1%	1 16.7%	2 13.3%
White	6 66.7%	5 83.3%	11 73.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	2 22.2%	0 0%	2 13.3%

Outcome Measures

1. Primary Outcome

Title	HPV-Specific T Cell Response Rate
Description	Response rate defined as proportion of participants with a >2-fold increase in HPV-specific T cell response from baseline to time of surgery.
Time Frame	At time of surgery

Outcome Measure Data

Analysis Population Description

The analysis included participants who had HPV-specific T cell response measurement at time of surgery. T cell response data were not collected at time of surgery for the control group, which was an optional observational group.

Arm/Group Title	Treatment-Vaccine Group	Control Group
Arm/Group Description	Two vaccinations with ADXS11-001 (ADXS-HPV) will be given at a dose of 1x10^9 cfu intravenously. The drug will be given as a 500ml infusion over 60 minutes. ADXS11-001 (ADXS-HPV): ADXS11-001 (ADXS-HPV) is a live attenuated Listeria monocytogenes (Lm)-LLO immunotherapy developed for the treatment of HPV-associated dysplasia and malignancy.	Observational control group treated with standard of care therapy only
Measure Participants	9	0
Number (95% Confidence Interval) [proportion of participants]	0.333 3.7%

2. Primary Outcome

Title	Number of Participants With Any Grade 3 or 4 Toxicity
Description	Degree of toxicity assessed according to NCI Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria.
Time Frame	Assessed up to 30 Days after surgery

Outcome Measure Data

Analysis Population Description

All participants were included in the analysis.

Arm/Group Title	Treatment-Vaccine Group	Control Group
Arm/Group Description	Two vaccinations with ADXS11-001 (ADXS-HPV) will be given at a dose of 1x10^9 cfu intravenously. The drug will be given as a 500ml infusion over 60 minutes. ADXS11-001 (ADXS-HPV): ADXS11-001 (ADXS-HPV) is a live attenuated Listeria monocytogenes (Lm)-LLO immunotherapy developed for the treatment of HPV-associated dysplasia and malignancy.	Observational control group treated with standard of care therapy only
Measure Participants	9	6
Count of Participants [Participants]	5 55.6%	1 16.7%

3. Secondary Outcome

Title	HPV-Specific T Cell Response Rate
Description	Response rate defined as proportion of participants with a >2-fold increase in HPV-specific T cell response from baseline to 3 months after surgery.
Time Frame	Assessed up to 3 months after surgery

Outcome Measure Data

Analysis Population Description

The analysis included participants who had at least one HPV-specific T cell response measurement post surgery.

Arm/Group Title	Treatment-Vaccine Group	Control Group
Arm/Group Description	Two vaccinations with ADXS11-001 (ADXS-HPV) will be given at a dose of 1x10^9 cfu intravenously. The drug will be given as a 500ml infusion over 60 minutes. ADXS11-001 (ADXS-HPV): ADXS11-001 (ADXS-HPV) is a live attenuated Listeria monocytogenes (Lm)-LLO immunotherapy developed for the treatment of HPV-associated dysplasia and malignancy.	Observational control group treated with standard of care therapy only
Measure Participants	8	4
Number (95% Confidence Interval) [proportion of participants]	0.625 6.9%	0.75 12.5%

Adverse Events

Time Frame	Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse Event Reporting Description	Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
Arm/Group Title	Treatment-Vaccine Group		Control Group
Arm/Group Description	Two vaccinations with ADXS11-001 (ADXS-HPV) will be given at a dose of 1x10^9 cfu intravenously. The drug will be given as a 500ml infusion over 60 minutes. ADXS11-001 (ADXS-HPV): ADXS11-001 (ADXS-HPV) is a live attenuated Listeria monocytogenes (Lm)-LLO immunotherapy developed for the treatment of HPV-associated dysplasia and malignancy.		Observational control group treated with standard of care therapy only
All Cause Mortality
	Treatment-Vaccine Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/9 (11.1%)		0/6 (0%)
Serious Adverse Events
	Treatment-Vaccine Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/9 (55.6%)		1/6 (16.7%)
Cardiac disorders
Hypertension	1/9 (11.1%)	2	0/6 (0%)	0
Gastrointestinal disorders
Dysphagia	1/9 (11.1%)	1	0/6 (0%)	0
Vomitting	1/9 (11.1%)	1	0/6 (0%)	0
General disorders
Failure to thrive	1/9 (11.1%)	1	0/6 (0%)	0
Mouth pain	0/9 (0%)	0	1/6 (16.7%)	1
Pain in throat and left ear when swollowing	1/9 (11.1%)	1	0/6 (0%)	0
Skin and subcutaneous tissue disorders
Dermatitis	1/9 (11.1%)	1	0/6 (0%)	0
mucositis	0/9 (0%)	0	1/6 (16.7%)	1
Other (Not Including Serious) Adverse Events
	Treatment-Vaccine Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/9 (100%)		6/6 (100%)
Blood and lymphatic system disorders
Decreased WBCs	1/9 (11.1%)	1	0/6 (0%)	0
Leukopenia	1/9 (11.1%)	2	0/6 (0%)	0
Localized edema	1/9 (11.1%)	1	0/6 (0%)	0
Monocytosis	1/9 (11.1%)	1	0/6 (0%)	0
Neutrophil count decreased	1/9 (11.1%)	1	0/6 (0%)	0
White blood cell decreased	1/9 (11.1%)	1	0/6 (0%)	0
lymphedema	0/9 (0%)	0	1/6 (16.7%)	1
Cardiac disorders
Hypertension	2/9 (22.2%)	2	0/6 (0%)	0
Hypotension	1/9 (11.1%)	1	0/6 (0%)	0
Tachycardia	1/9 (11.1%)	1	0/6 (0%)	0
Tachycardia (HR112)	1/9 (11.1%)	1	0/6 (0%)	0
Tachychardia	1/9 (11.1%)	1	0/6 (0%)	0
Ear and labyrinth disorders
Tinnitus	0/9 (0%)	0	1/6 (16.7%)	1
Endocrine disorders
Face Flushing	1/9 (11.1%)	1	0/6 (0%)	0
Flushed Face	1/9 (11.1%)	1	0/6 (0%)	0
Flushing	2/9 (22.2%)	2	0/6 (0%)	0
Flushing (face+neck)	1/9 (11.1%)	1	0/6 (0%)	0
Sweating	2/9 (22.2%)	2	0/6 (0%)	0
Gastrointestinal disorders
Abdominal pain	1/9 (11.1%)	1	0/6 (0%)	0
Constipation	6/9 (66.7%)	7	2/6 (33.3%)	2
Diarrhea	2/9 (22.2%)	2	1/6 (16.7%)	1
Difficulty with swallowing solid food	0/9 (0%)	0	1/6 (16.7%)	1
Dysphagia	7/9 (77.8%)	12	1/6 (16.7%)	1
Heartburn	0/9 (0%)	0	1/6 (16.7%)	1
Intermittent diarrhea after taking Bactrim	1/9 (11.1%)	1	0/6 (0%)	0
Nausea	4/9 (44.4%)	7	2/6 (33.3%)	2
Upset Stomach	1/9 (11.1%)	1	0/6 (0%)	0
Vomiting	1/9 (11.1%)	1	2/6 (33.3%)	2
Vomitting	1/9 (11.1%)	1	1/6 (16.7%)	1
constipation	0/9 (0%)	0	1/6 (16.7%)	1
tongue ulcer	0/9 (0%)	0	1/6 (16.7%)	1
General disorders
Anorexia	3/9 (33.3%)	3	0/6 (0%)	0
Body ache	3/9 (33.3%)	3	0/6 (0%)	0
Chill	1/9 (11.1%)	1	0/6 (0%)	0
Chills	7/9 (77.8%)	10	0/6 (0%)	0
Dry Mouth	0/9 (0%)	0	1/6 (16.7%)	1
Dry mouth	1/9 (11.1%)	1	2/6 (33.3%)	2
Ear pain	0/9 (0%)	0	1/6 (16.7%)	1
Fatigue	5/9 (55.6%)	8	1/6 (16.7%)	1
Fever	5/9 (55.6%)	7	0/6 (0%)	0
Intermittent throat pain when swallowing	1/9 (11.1%)	2	0/6 (0%)	0
Jaw pain	0/9 (0%)	0	1/6 (16.7%)	1
Left Ear Pain	0/9 (0%)	0	1/6 (16.7%)	1
Mild discomfort in the throat on the left side	1/9 (11.1%)	1	0/6 (0%)	0
Mild odynophagia	0/9 (0%)	0	1/6 (16.7%)	1
Mild throat pain	0/9 (0%)	0	1/6 (16.7%)	1
Neck Mass	0/9 (0%)	0	1/6 (16.7%)	1
Occasional fatigue	1/9 (11.1%)	1	0/6 (0%)	0
Occasional pain in throat	1/9 (11.1%)	1	0/6 (0%)	0
Pain	1/9 (11.1%)	1	3/6 (50%)	3
Pain (in neck)	0/9 (0%)	0	1/6 (16.7%)	1
Pain (in throat)	0/9 (0%)	0	1/6 (16.7%)	1
Pain in left jaw	1/9 (11.1%)	1	0/6 (0%)	0
Pain in legs	1/9 (11.1%)	1	0/6 (0%)	0
Pain in neck	0/9 (0%)	0	1/6 (16.7%)	1
Pain in right ear	1/9 (11.1%)	1	0/6 (0%)	0
Pain in right ear,nec	1/9 (11.1%)	1	0/6 (0%)	0
Pain in right shoulder	1/9 (11.1%)	1	1/6 (16.7%)	2
Pain in right side of neck	0/9 (0%)	0	1/6 (16.7%)	1
Right Neck Pain	0/9 (0%)	0	1/6 (16.7%)	1
Right Shoulder Pain	1/9 (11.1%)	1	0/6 (0%)	0
Shivering	1/9 (11.1%)	2	0/6 (0%)	0
Slight sore throat	1/9 (11.1%)	1	0/6 (0%)	0
Throat pain	2/9 (22.2%)	2	0/6 (0%)	0
Tonsillar Pain	0/9 (0%)	0	1/6 (16.7%)	1
Weakening	1/9 (11.1%)	1	0/6 (0%)	0
Xerostomia	1/9 (11.1%)	1	1/6 (16.7%)	1
dry saliva	0/9 (0%)	0	1/6 (16.7%)	1
left buccal mucosa lump	0/9 (0%)	0	1/6 (16.7%)	1
minor discomfort when swallowing	1/9 (11.1%)	1	0/6 (0%)	0
pain in right neck	1/9 (11.1%)	1	0/6 (0%)	0
pain in right neck, shoulder	1/9 (11.1%)	1	0/6 (0%)	0
pain in shoulder	0/9 (0%)	0	1/6 (16.7%)	1
pain in throat	3/9 (33.3%)	5	0/6 (0%)	0
pressure in the right neck	0/9 (0%)	0	1/6 (16.7%)	1
slight tightness on outside of left neck at surgical site when out in the cold only	1/9 (11.1%)	1	0/6 (0%)	0
tooth decay	0/9 (0%)	0	1/6 (16.7%)	1
Metabolism and nutrition disorders
Gout	1/9 (11.1%)	1	0/6 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	1/9 (11.1%)	1	0/6 (0%)	0
Intermittent neck stiffness	0/9 (0%)	0	1/6 (16.7%)	1
Myalgia	1/9 (11.1%)	1	0/6 (0%)	0
Trismus	0/9 (0%)	0	1/6 (16.7%)	1
cramping in feet	1/9 (11.1%)	1	0/6 (0%)	0
Nervous system disorders
Decreased taste	0/9 (0%)	0	1/6 (16.7%)	1
Dysarthria	0/9 (0%)	0	1/6 (16.7%)	1
Dysgeusia	2/9 (22.2%)	2	0/6 (0%)	0
Headache	3/9 (33.3%)	5	0/6 (0%)	0
Headache Intermittent	1/9 (11.1%)	1	0/6 (0%)	0
Loss of taste	0/9 (0%)	0	1/6 (16.7%)	2
Memory loss and cognitive decline	1/9 (11.1%)	1	0/6 (0%)	0
Numbness right Ear,Neck and back of head	0/9 (0%)	0	1/6 (16.7%)	1
dysgeusia	1/9 (11.1%)	1	1/6 (16.7%)	1
headache	1/9 (11.1%)	1	0/6 (0%)	0
Psychiatric disorders
Anxiety	1/9 (11.1%)	1	0/6 (0%)	0
Depression	0/9 (0%)	0	1/6 (16.7%)	1
Euphoria	1/9 (11.1%)	1	0/6 (0%)	0
Respiratory, thoracic and mediastinal disorders
Blood tinged sputum	1/9 (11.1%)	1	0/6 (0%)	0
Hoarseness	1/9 (11.1%)	1	2/6 (33.3%)	2
Voice Change	0/9 (0%)	0	1/6 (16.7%)	1
voice changes	0/9 (0%)	0	1/6 (16.7%)	1
Skin and subcutaneous tissue disorders
Mucositis	1/9 (11.1%)	1	0/6 (0%)	0
Rash	2/9 (22.2%)	2	0/6 (0%)	0
Rash (chest, back of neck)	1/9 (11.1%)	1	0/6 (0%)	0
left lump posterior pharyngeal region	0/9 (0%)	0	1/6 (16.7%)	1
radiation associated dermatitis	0/9 (0%)	0	1/6 (16.7%)	1
tender left arm lump	0/9 (0%)	0	1/6 (16.7%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.