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Eligible are women with metastatic breast cancer and patients with other metastatic solid tumors who have achieved stable disease or have disease progression after systemic therapy and have at least three separate measurable sites of disease. Extent of metastatic disease is recorded both at CT and PET scanning. Radiation is given during systemic therapy to one of the lesions, 35 Gy in ten fractions over a two week interval, conformally to maximally spare normal tissue. GM-CSF treatment is given daily for fourteen days. At day 22 radiation is re-started and the same radiation dose is delivered to a second metastatic site, again with GM-CSF. Abscopal response is evaluated by assessing clinical and PET response in the non-irradiated measurable metastatic sites. A Phase II clinical trial based on an optimum two-stage Phase II Simon design is used to conduct this pilot study. Ten patients will be treated in Stage one; if there are no abscopal responses, the trial will be terminated. If there are one or more abscopal responses in Stage One, the trial will proceed to enroll an additional 19 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation therapy | Experimental | Patients with metastatic breast cancer and other metastatic solid tumors receiving single-agent chemotherapy will receive 3.5 Gy/fraction to a total dose of 35 Gy/10 fractions over 2 weeks with concurrent systemic therapy Systemic agents are either capecitabine (Xeloda), paclitaxel, docitaxel or taxol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation therapy | Radiation | Patients with metastatic breast cancer and other metastatic solid tumors receiving single-agent chemotherapy will receive 3.5 Gy/fraction to a total dose of 35 Gy/10 fractions over 2 weeks with concurrent systemic therapy |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with an abscopal response assessed at 7-8 weeks after the initiation of treatment. | week 7- week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of participants with adverse events from the date of enrollment until 12 years from the opening of the study. | year 0 - year 12 | |
| The proportion of patients alive with abscopal responses from the date of enrollment until date of death from any cause, assessed up to 12 years from the opening of the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Encouse Golden, M.D., Ph.D. | NYU School of Medicine | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26095785 | Derived | Golden EB, Chhabra A, Chachoua A, Adams S, Donach M, Fenton-Kerimian M, Friedman K, Ponzo F, Babb JS, Goldberg J, Demaria S, Formenti SC. Local radiotherapy and granulocyte-macrophage colony-stimulating factor to generate abscopal responses in patients with metastatic solid tumours: a proof-of-principle trial. Lancet Oncol. 2015 Jul;16(7):795-803. doi: 10.1016/S1470-2045(15)00054-6. Epub 2015 Jun 18. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D000069287 | Capecitabine |
| D017239 | Paclitaxel |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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|
| Xeloda | Drug | chemotherapy agent daily for two weeks |
|
|
| paclitaxel | Drug | chemotherapy agent weekly for two weeks |
|
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| year 0- year 12 |
| D009385 |
| Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |