Toll-like Receptor (TLR) 7 Agonist, Cyclophosphamide, and Radiotherapy for Breast Cancer With Skin Metastases

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT01421017
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 31
• Location: 1
• Arms: 3
• Actual Duration (Months): 59.6
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This study is to find an optimal dose of Imiquimod (IMQ) in the first part (Phase I) and test the effectiveness of the combination treatment of IMQ, cyclophosphamide (CTX), and radiotherapy (RT) in patients with skin metastases from breast cancer in the second part (Phase II). Currently this trial is in its Phase II part.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Metastatic Breast Cancer; Recurrent Breast Cancer	Radiation: Radiation; Drug: Imiquimod; Drug: Cyclophosphamide	Phase 1/Phase 2

Detailed Description

By harnessing the cytocidal and immunostimulatory properties of two local treatment modalities, RT and IMQ, an effective, adaptive immune response can be generated, resulting in systemic control of metastatic breast cancer after local treatment of cutaneous metastases. Additionally, based on investigators' recent preclinical data, the investigators intend to estimate in patients with metastatic breast cancer, if the addition of immunomodulatory cyclophosphamide can increase anti-tumor responses.

This trial originally had one treatment arm IMQ/RT(patients were treated with IMQ and RT). Recent evidence has emerged that the addition of immunomodulatory cyclophosphamide (CTX) increased anti-tumor responses, therefore the IMQ/RT arm is closed and the trial will continue with two additional cohorts (CTX/IMQ/RT and CTX/RT) which include cyclophosphamide.

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I/II Study of TLR7 Agonist Imiquimod, Cyclophosphamide, and Radiotherapy in Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases
• Actual Study Start Date: Aug 19, 2011
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Aug 6, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IMQ+RT This arm has been closed as of 6/4/2014. Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period. Week 9: response assessment Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.	Radiation: Radiation; Drug: Imiquimod; Other Names: ALDARA
Experimental: CTX/IMQ/RT Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period. Week 9: response assessment Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.	Radiation: Radiation; Drug: Imiquimod; Other Names: ALDARA ; Drug: Cyclophosphamide; Other Names: Cytoxan
Experimental: CTX/RT For patients with only non-skin metastatic sites First cycle (Cycle 1): Week -1 (day -7): cyclophosphamide 200mg/m2 IV as single infusion Weeks 1-2: RT given to one site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Week 9: response assessment Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.	Radiation: Radiation; Drug: Cyclophosphamide; Other Names: Cytoxan

Outcome Measures

Primary Outcome Measures

1. Systemic Tumor Response Rates (Complete Response+Partial Response) [9 weeks from the start of the treatment of RT]

   The systemic tumor response refers to the response at the time of best overall response. The response criteria are specially adapted from Response Evaluation Criteria in Solid Tumor for Immunotherapies (Wolchok, et al., 2009).

Secondary Outcome Measures

1. Local Skin Tumor Response Rates (Complete Response + Partial Response) [9 weeks from the start of the treatment]

   The response refers to the best overall response, based on European Organization for Research and Treatment of Cancer's definitions for chest wall tumors (Kouloulias, et al., 2002).

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Patients with biopsy-confirmed breast cancer.

2. Patients with at least measurable skin metastases and distant, measurable metastases (outside of skin) by Response Evaluation Criteria in Solid Tumors (RECIST). For patients without distant measurable metastases, an area of the skin metastases designated to not receive local therapy can be substituted. Patients with multiple (>=

1. metastatic sites (skin involvement not required), with at least one site measurable by RECIST, will be eligible for the CTX/RT cohort.

1. Age >= 18 years.

2. Eastern Cooperative Oncology Group performance status 0-2.

3. Patients must agree to tumor fine-needle aspiration required by protocol.

4. Concurrent systemic cancer therapy (hormones, biologics or chemotherapy) can be continued if distant metastases are non-responsive (i.e. no complete response or partial response) on that regimen for >= 8 weeks as assessed by the investigator.

5. Patients must have adequate organ and bone marrow function as defined below:

• absolute neutrophil count >= 1,300/microliter

• hemoglobin >= 9.0 grams/deciliter

• platelets >= 75,000/microliter

• total bilirubin =< 1.5 X institutional upper limit of normal

• AST (aspartate aminotransferase) =< 2.5 X institutional upper limit of normal

• ALT (alanine aminotransferase) =< 2.5 X institutional upper limit of normal

• creatinine =< 2 X institutional upper limit of normal if patient has chronic renal insufficiency and creatinine has been stable for > 4 months)

1. Informed consent.

Exclusion Criteria:

1. Brain metastases unless resected or irradiated and stable >= 4 weeks.

2. Concurrent treatment with other investigational agents.

3. Patients who have received any local therapy (radiotherapy, high-potency corticosteroids, intralesional therapy, laser therapy or surgery) other than biopsy to the target area within 4 weeks prior to first dosing of study agent.

4. Patients who have received hyperthermia to the target area within 10 weeks prior to first dosing of study agent.

5. Patients with an uncontrolled bleeding disorder.

6. Patients (with skin metastases only) who will be therapeutically anticoagulated with heparins or coumadin at the time of the biopsy (they are eligible if anticoagulation can be held prior to biopsy as per investigator). Patients on aspirin and other platelet agents are eligible.

7. Patients with known immunodeficiency or receiving immunosuppressive therapies.

8. History of allergic reactions to imiquimod or its excipients.

9. Uncontrolled intercurrent medical illness or psychiatric illness/social situations that would limit compliance with study requirements.

10. Pregnancy or lactation.

11. Women of childbearing potential not using a medically acceptable means of contraception.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University Medical Center	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Sylvia Adams, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

• Kouloulias VE, Dardoufas CE, Kouvaris JR, Gennatas CS, Polyzos AK, Gogas HJ, Sandilos PH, Uzunoglu NK, Malas EG, Vlahos LJ. Liposomal doxorubicin in conjunction with reirradiation and local hyperthermia treatment in recurrent breast cancer: a phase I/II trial. Clin Cancer Res. 2002 Feb;8(2):374-82.
• Wolchok JD, Hoos A, O'Day S, Weber JS, Hamid O, Lebbé C, Maio M, Binder M, Bohnsack O, Nichol G, Humphrey R, Hodi FS. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res. 2009 Dec 1;15(23):7412-20. doi: 10.1158/1078-0432.CCR-09-1624. Epub 2009 Nov 24.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT01421017
• Other Study ID Numbers: 11-00598; 1R01CA161891-01
• First Posted: Aug 22, 2011
• Last Update Posted: Nov 18, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by NYU Langone Health: radiation therapy; combination therapy; immunotherapy; immune response modifier; immunostimulatory; immunomodulator
• Additional relevant MeSH terms: Breast Neoplasms; Cyclophosphamide; Imiquimod

Study Results

Participant Flow

Arm/Group Title	IMQ+RT	CTX/IMQ/RT	CTX/RT
Arm/Group Description	This arm has been closed as of 6/4/2014. Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period. Week 9: response assessment Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator. Radiation Imiquimod	Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period. Week 9: response assessment Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator. Radiation Imiquimod Cyclophosphamide	For patients with only non-skin metastatic sites First cycle (Cycle 1): Week -1 (day -7): cyclophosphamide 200mg/m2 IV as single infusion Weeks 1-2: RT given to one site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Week 9: response assessment Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator. Radiation Cyclophosphamide
Period Title: Overall Study
STARTED	12	12	7
COMPLETED	10	6	4
NOT COMPLETED	2	6	3

Baseline Characteristics

Arm/Group Title	IMQ+RT	CTX/IMQ/RT	CTX/RT	Total
Arm/Group Description	This arm has been closed as of 6/4/2014. Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period. Week 9: response assessment Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator. Radiation Imiquimod	Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period. Week 9: response assessment Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator. Radiation Imiquimod Cyclophosphamide	For patients with only non-skin metastatic sites First cycle (Cycle 1): Week -1 (day -7): cyclophosphamide 200mg/m2 IV as single infusion Weeks 1-2: RT given to one site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Week 9: response assessment Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator. Radiation Cyclophosphamide	Total of all reporting groups
Overall Participants	12	12	7	31
Age, Customized (years) [Mean (Standard Deviation) ]
Mean Age	67 (6.2)	51 (7.4)	51 (7.1)	57 (6)
Sex: Female, Male (Count of Participants)
Female	12 100%	12 100%	6 85.7%	30 96.8%
Male	0 0%	0 0%	1 14.3%	1 3.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 16.7%	0 0%	1 14.3%	3 9.7%
Not Hispanic or Latino	10 83.3%	12 100%	6 85.7%	28 90.3%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	1 8.3%	2 16.7%	3 42.9%	6 19.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	1 8.3%	2 16.7%	2 28.6%	5 16.1%
White	8 66.7%	8 66.7%	1 14.3%	17 54.8%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	2 16.7%	0 0%	1 14.3%	3 9.7%
Region of Enrollment (participants) [Number]
United States	12 100%	12 100%	7 100%	31 100%

Outcome Measures

1. Primary Outcome

Title	Systemic Tumor Response Rates (Complete Response+Partial Response)
Description	The systemic tumor response refers to the response at the time of best overall response. The response criteria are specially adapted from Response Evaluation Criteria in Solid Tumor for Immunotherapies (Wolchok, et al., 2009).
Time Frame	9 weeks from the start of the treatment of RT

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IMQ+RT	CTX/IMQ/RT	CTX/RT
Arm/Group Description	This arm has been closed as of 6/4/2014. Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period. Week 9: response assessment Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator. Radiation Imiquimod	Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period. Week 9: response assessment Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator. Radiation Imiquimod Cyclophosphamide	For patients with only non-skin metastatic sites First cycle (Cycle 1): Week -1 (day -7): cyclophosphamide 200mg/m2 IV as single infusion Weeks 1-2: RT given to one site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Week 9: response assessment Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator. Radiation Cyclophosphamide
Measure Participants	12	12	7
Number (95% Confidence Interval) [proportion of tumors]	.25	.083	0

2. Secondary Outcome

Title	Local Skin Tumor Response Rates (Complete Response + Partial Response)
Description	The response refers to the best overall response, based on European Organization for Research and Treatment of Cancer's definitions for chest wall tumors (Kouloulias, et al., 2002).
Time Frame	9 weeks from the start of the treatment

Outcome Measure Data

Analysis Population Description

Arm "CTX/RT" is not applicable, as it includes only patients with non-skin metastatic sites.

Arm/Group Title	IMQ+RT	CTX/IMQ/RT
Arm/Group Description	This arm has been closed as of 6/4/2014. Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period. Week 9: response assessment Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator. Radiation Imiquimod	Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period. Week 9: response assessment Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator. Radiation Imiquimod Cyclophosphamide
Measure Participants	12	12
Local Area A; irradiated area	0.83	0.75
Local Area B; non-irradiated area	.33	.083

Adverse Events

Time Frame	8 weeks
Arm/Group Title	IMQ+RT		CTX/IMQ/RT		CTX/RT
Arm/Group Description	This arm has been closed as of 6/4/2014. Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period. Week 9: response assessment Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator. Radiation Imiquimod		Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period. Week 9: response assessment Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator. Radiation Imiquimod Cyclophosphamide		For patients with only non-skin metastatic sites First cycle (Cycle 1): Week -1 (day -7): cyclophosphamide 200mg/m2 IV as single infusion Weeks 1-2: RT given to one site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Week 9: response assessment Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator. Radiation Cyclophosphamide
All Cause Mortality
	IMQ+RT		CTX/IMQ/RT		CTX/RT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)		0/7 (0%)
Serious Adverse Events
	IMQ+RT		CTX/IMQ/RT		CTX/RT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/12 (16.7%)		3/12 (25%)		1/7 (14.3%)
Eye disorders
Blurred Vision	0/12 (0%)		0/12 (0%)		1/7 (14.3%)
General disorders
Breast Pain	1/12 (8.3%)		0/12 (0%)		0/7 (0%)
Fever	1/12 (8.3%)		0/12 (0%)		0/7 (0%)
Tumor Pain	2/12 (16.7%)		0/12 (0%)		0/7 (0%)
Headache	0/12 (0%)		1/12 (8.3%)		0/7 (0%)
Pain in extremity	0/12 (0%)		1/12 (8.3%)		0/7 (0%)
Infections and infestations
Breast Infection	1/12 (8.3%)		0/12 (0%)		0/7 (0%)
Skin Infection	1/12 (8.3%)		1/12 (8.3%)		0/7 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neosplasms Benign	1/12 (8.3%)		0/12 (0%)		0/7 (0%)
Nervous system disorders
Dysarthria	0/12 (0%)		1/12 (8.3%)		0/7 (0%)
Respiratory, thoracic and mediastinal disorders
Pleural Effusion	0/12 (0%)		1/12 (8.3%)		0/7 (0%)
Adult respiratory disorder	0/12 (0%)		1/12 (8.3%)		0/7 (0%)
Skin and subcutaneous tissue disorders
Skin ulceration	1/12 (8.3%)		0/12 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	IMQ+RT		CTX/IMQ/RT		CTX/RT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/12 (100%)		12/12 (100%)		7/7 (100%)
Blood and lymphatic system disorders
Anemia	12/12 (100%)		12/12 (100%)		7/7 (100%)
Lymphedema	0/12 (0%)		12/12 (100%)		0/7 (0%)
Blood bilirubin increased	0/12 (0%)		0/12 (0%)		7/7 (100%)
Eye disorders
Blurred Vision	0/12 (0%)		0/12 (0%)		7/7 (100%)
Gastrointestinal disorders
Constipation	0/12 (0%)		12/12 (100%)		7/7 (100%)
Diarrhea	0/12 (0%)		12/12 (100%)		7/7 (100%)
Abdominal Distension	12/12 (100%)		0/12 (0%)		7/7 (100%)
Alkaline Phosphatase Increased	0/12 (0%)		0/12 (0%)		7/7 (100%)
Aspartate Aminotransferase Increased	0/12 (0%)		0/12 (0%)		7/7 (100%)
Vomiting	0/12 (0%)		0/12 (0%)		7/7 (100%)
General disorders
Back Pain	0/12 (0%)		12/12 (100%)		0/7 (0%)
Breast Pain	12/12 (100%)		12/12 (100%)		0/7 (0%)
Fatigue	12/12 (100%)		12/12 (100%)		7/7 (100%)
Headache	0/12 (0%)		12/12 (100%)		0/7 (0%)
Nausea	12/12 (100%)		12/12 (100%)		7/7 (100%)
Pain	12/12 (100%)		12/12 (100%)		0/7 (0%)
Body Odor	12/12 (100%)		0/12 (0%)		0/7 (0%)
Dehydration	12/12 (100%)		0/12 (0%)		0/7 (0%)
Fever	12/12 (100%)		0/12 (0%)		7/7 (100%)
Insomnia	12/12 (100%)		0/12 (0%)		0/7 (0%)
Immune system disorders
Febrile Neutropenia	12/12 (100%)		0/12 (0%)		0/7 (0%)
Infections and infestations
Breast Infection	12/12 (100%)		0/12 (0%)		0/7 (0%)
Metabolism and nutrition disorders
Anorexia	12/12 (100%)		0/12 (0%)		0/7 (0%)
Weight Loss	12/12 (100%)		0/12 (0%)		7/7 (100%)
Musculoskeletal and connective tissue disorders
Arthralgia	12/12 (100%)		12/12 (100%)		0/7 (0%)
Dysarthria	0/12 (0%)		12/12 (100%)		0/7 (0%)
Myalgia	12/12 (100%)		12/12 (100%)		0/7 (0%)
Paresthesia	0/12 (0%)		12/12 (100%)		7/7 (100%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant, and unspecified	12/12 (100%)		0/12 (0%)		0/7 (0%)
Psychiatric disorders
Anxiety	0/12 (0%)		12/12 (100%)		0/7 (0%)
Depression	0/12 (0%)		12/12 (100%)		0/7 (0%)
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome	0/12 (0%)		12/12 (100%)		0/7 (0%)
Cough	0/12 (0%)		12/12 (100%)		7/7 (100%)
Skin and subcutaneous tissue disorders
Alopecia	0/12 (0%)		12/12 (100%)		0/7 (0%)
Dermatitis Radiation	12/12 (100%)		12/12 (100%)		0/7 (0%)
Erythema Multiforma	12/12 (100%)		0/12 (0%)		0/7 (0%)
Pruitus	12/12 (100%)		0/12 (0%)		0/7 (0%)

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.