Toll-like Receptor (TLR) 7 Agonist, Cyclophosphamide, and Radiotherapy for Breast Cancer With Skin Metastases
NCT ID: NCT01421017
Last Updated: 2021-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
31 participants
INTERVENTIONAL
2011-08-19
2016-08-06
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Imiquimod
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
Imiquimod
Cyclophosphamide
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
Cyclophosphamide
Interventions
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Radiation
Imiquimod
Cyclophosphamide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 (\>= 2) metastatic sites (skin involvement not required), with at least one site measurable by RECIST, will be eligible for the CTX/RT cohort.
3. Age \>= 18 years.
4. Eastern Cooperative Oncology Group performance status 0-2.
5. Patients must agree to tumor fine-needle aspiration required by protocol.
6. 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.
7. 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)
8. Informed consent.
Exclusion Criteria
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.
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Sylvia Adams, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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New York University Medical Center
New York, New York, United States
Countries
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References
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Wolchok JD, Hoos A, O'Day S, Weber JS, Hamid O, Lebbe 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.
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.
Adams S, Demaria S, Rinchai D, Wang E, Novik Y, Oratz R, Fenton-Kerimian M, Levine PG, Li X, Marincola F, Jin P, Stroncek D, Goldberg J, Bedognetti D, Formenti SC. Topical TLR7 agonist and radiotherapy in patients with metastatic breast cancer. J Immunother Cancer. 2025 Apr 5;13(4):e011173. doi: 10.1136/jitc-2024-011173.
Other Identifiers
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11-00598
Identifier Type: -
Identifier Source: org_study_id