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)
31
Enrollment
1
Location
3
Arms
59.6
Actual Duration (Months)
0.5
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
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

ArmIntervention/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

    SiteCityStateCountryPostal Code
    1New York University Medical CenterNew YorkNew YorkUnited States10016

    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

    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
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleIMQ+RTCTX/IMQ/RTCTX/RT
    Arm/Group DescriptionThis 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 ImiquimodWeek -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 CyclophosphamideFor 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
    STARTED12127
    COMPLETED1064
    NOT COMPLETED263

    Baseline Characteristics

    Arm/Group TitleIMQ+RTCTX/IMQ/RTCTX/RTTotal
    Arm/Group DescriptionThis 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 ImiquimodWeek -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 CyclophosphamideFor 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 CyclophosphamideTotal of all reporting groups
    Overall Participants1212731
    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
    TitleSystemic Tumor Response Rates (Complete Response+Partial Response)
    DescriptionThe 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 Frame9 weeks from the start of the treatment of RT

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleIMQ+RTCTX/IMQ/RTCTX/RT
    Arm/Group DescriptionThis 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 ImiquimodWeek -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 CyclophosphamideFor 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 Participants12127
    Number (95% Confidence Interval) [proportion of tumors]
    .25
    .083
    0
    2. Secondary Outcome
    TitleLocal Skin Tumor Response Rates (Complete Response + Partial Response)
    DescriptionThe 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 Frame9 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 TitleIMQ+RTCTX/IMQ/RT
    Arm/Group DescriptionThis 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 ImiquimodWeek -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 Participants1212
    Local Area A; irradiated area
    0.83
    0.75
    Local Area B; non-irradiated area
    .33
    .083

    Adverse Events

    Time Frame8 weeks
    Adverse Event Reporting Description
    Arm/Group TitleIMQ+RTCTX/IMQ/RTCTX/RT
    Arm/Group DescriptionThis 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 ImiquimodWeek -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 CyclophosphamideFor 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+RTCTX/IMQ/RTCTX/RT
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/12 (0%) 0/12 (0%) 0/7 (0%)
    Serious Adverse Events
    IMQ+RTCTX/IMQ/RTCTX/RT
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total2/12 (16.7%) 3/12 (25%) 1/7 (14.3%)
    Eye disorders
    Blurred Vision0/12 (0%) 0/12 (0%) 1/7 (14.3%)
    General disorders
    Breast Pain1/12 (8.3%) 0/12 (0%) 0/7 (0%)
    Fever1/12 (8.3%) 0/12 (0%) 0/7 (0%)
    Tumor Pain2/12 (16.7%) 0/12 (0%) 0/7 (0%)
    Headache0/12 (0%) 1/12 (8.3%) 0/7 (0%)
    Pain in extremity0/12 (0%) 1/12 (8.3%) 0/7 (0%)
    Infections and infestations
    Breast Infection1/12 (8.3%) 0/12 (0%) 0/7 (0%)
    Skin Infection1/12 (8.3%) 1/12 (8.3%) 0/7 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neosplasms Benign1/12 (8.3%) 0/12 (0%) 0/7 (0%)
    Nervous system disorders
    Dysarthria0/12 (0%) 1/12 (8.3%) 0/7 (0%)
    Respiratory, thoracic and mediastinal disorders
    Pleural Effusion0/12 (0%) 1/12 (8.3%) 0/7 (0%)
    Adult respiratory disorder0/12 (0%) 1/12 (8.3%) 0/7 (0%)
    Skin and subcutaneous tissue disorders
    Skin ulceration1/12 (8.3%) 0/12 (0%) 0/7 (0%)
    Other (Not Including Serious) Adverse Events
    IMQ+RTCTX/IMQ/RTCTX/RT
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total12/12 (100%) 12/12 (100%) 7/7 (100%)
    Blood and lymphatic system disorders
    Anemia12/12 (100%) 12/12 (100%) 7/7 (100%)
    Lymphedema0/12 (0%) 12/12 (100%) 0/7 (0%)
    Blood bilirubin increased0/12 (0%) 0/12 (0%) 7/7 (100%)
    Eye disorders
    Blurred Vision0/12 (0%) 0/12 (0%) 7/7 (100%)
    Gastrointestinal disorders
    Constipation0/12 (0%) 12/12 (100%) 7/7 (100%)
    Diarrhea0/12 (0%) 12/12 (100%) 7/7 (100%)
    Abdominal Distension12/12 (100%) 0/12 (0%) 7/7 (100%)
    Alkaline Phosphatase Increased0/12 (0%) 0/12 (0%) 7/7 (100%)
    Aspartate Aminotransferase Increased0/12 (0%) 0/12 (0%) 7/7 (100%)
    Vomiting0/12 (0%) 0/12 (0%) 7/7 (100%)
    General disorders
    Back Pain0/12 (0%) 12/12 (100%) 0/7 (0%)
    Breast Pain12/12 (100%) 12/12 (100%) 0/7 (0%)
    Fatigue12/12 (100%) 12/12 (100%) 7/7 (100%)
    Headache0/12 (0%) 12/12 (100%) 0/7 (0%)
    Nausea12/12 (100%) 12/12 (100%) 7/7 (100%)
    Pain12/12 (100%) 12/12 (100%) 0/7 (0%)
    Body Odor12/12 (100%) 0/12 (0%) 0/7 (0%)
    Dehydration12/12 (100%) 0/12 (0%) 0/7 (0%)
    Fever12/12 (100%) 0/12 (0%) 7/7 (100%)
    Insomnia12/12 (100%) 0/12 (0%) 0/7 (0%)
    Immune system disorders
    Febrile Neutropenia12/12 (100%) 0/12 (0%) 0/7 (0%)
    Infections and infestations
    Breast Infection12/12 (100%) 0/12 (0%) 0/7 (0%)
    Metabolism and nutrition disorders
    Anorexia12/12 (100%) 0/12 (0%) 0/7 (0%)
    Weight Loss12/12 (100%) 0/12 (0%) 7/7 (100%)
    Musculoskeletal and connective tissue disorders
    Arthralgia12/12 (100%) 12/12 (100%) 0/7 (0%)
    Dysarthria0/12 (0%) 12/12 (100%) 0/7 (0%)
    Myalgia12/12 (100%) 12/12 (100%) 0/7 (0%)
    Paresthesia0/12 (0%) 12/12 (100%) 7/7 (100%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasms benign, malignant, and unspecified12/12 (100%) 0/12 (0%) 0/7 (0%)
    Psychiatric disorders
    Anxiety0/12 (0%) 12/12 (100%) 0/7 (0%)
    Depression0/12 (0%) 12/12 (100%) 0/7 (0%)
    Respiratory, thoracic and mediastinal disorders
    Adult respiratory distress syndrome0/12 (0%) 12/12 (100%) 0/7 (0%)
    Cough0/12 (0%) 12/12 (100%) 7/7 (100%)
    Skin and subcutaneous tissue disorders
    Alopecia0/12 (0%) 12/12 (100%) 0/7 (0%)
    Dermatitis Radiation12/12 (100%) 12/12 (100%) 0/7 (0%)
    Erythema Multiforma12/12 (100%) 0/12 (0%) 0/7 (0%)
    Pruitus12/12 (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.

    Results Point of Contact

    Name/TitleSylvia Adams
    OrganizationNYU Langone Health
    Phone212-731-5795
    Emailsylvia.adams@nyumc.org
    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