Treatment of Cancer-Related Bone Pain by Using Bone-Targeted Radiation-Based Therapy (Sn-117m-DTPA) in Patients With Prostate Cancer That Has Spread to Bones : A Single Arm Phase II Study of Bone-Targeted Sn-117m-DTPA in Symptomatic Castration Resistant Prostate Cancer With Skeletal Metastases
PRIMARY OBJECTIVE:I. To evaluate the efficacy of tin-117m diethylenetriaminepentaacetic acid (Sn-117m-DTPA) on sustained pain response in patients with castration-resistant prostate cancer (CRPC) metastatic to at least two bone sites with at least one clinically meaningful pain at baseline (>= 4 on an 11-point pain intensity scale).SECONDARY OBJECTIVES:I. To assess the safety and tolerability of Sn-117m-DTPA per Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.II. To measure Sn-117m-DTPA activity by gamma-camera dosimetry scans (serial full body planar images) obtained at 1 hour, 4 hours (or within 4-6 hours), 24 hours (or within 16-24 hours), 48 hours (or within 36-48 hours), 72 hours (or within 60-72 hours), 1 week (+/- 2 days), and 4 weeks (+/- 2 days) after the first Sn-117m-DTPA administration.III. To evaluate the therapeutic efficacy of Sn-117m-DTPA at 24 weeks as measured by Prostate Cancer Working Group 3 (PCWG3) criteria.IV. To evaluate time to the first symptomatic skeletal event defined as i) the first use of external-beam radiation therapy to relieve skeletal symptoms; ii) new symptomatic pathologic vertebral or nonvertebral bone fractures; iii) spinal cord compression; or iv) tumor-related orthopedic surgical intervention.V. To evaluate the overall pain response rate at 24 weeks. VI. To evaluate the duration of pain response defined as from the time of improvement in pain response (pain index =< 3) until the pain recurs.VII. To measure changes and time to progression in serum prostate-specific antigen (PSA) and serum alkaline phosphatase (ALP) levels.VIII. To measure patient-reported outcomes (PROs) and adverse events (AEs) (PRO-CTCAE) captured by digital instruments.IX. To evaluate progression-free survival (PFS) and overall survival (OS).EXPLORATORY OBJECTIVES:I. To examine any tumor genomic alterations that may be associated with response or resistance to Sn-117m-DTPA, a radiopharmaceutical agent.II. To examine the changes in systemic inflammatory markers (such as interferon [IFN]-gamma, tumor necrosis factor [TNF]-alpha, interleukins [IL]-8, IL-10, and IL-17) by flow cytometry, and changes in markers of immune function by measuring the percentage and absolute number of CD4+ T helper cells, CD8+ T cytotoxic cells, T regulatory cells, polymorphonuclear (PMN) myeloid-derived suppressor cells (MDSCs), and mononuclear MDSCs (M-MDSCs) prior to treatment versus (vs.) end of cycle 1, end of cycle 2, and at week 24 and correlate values and/or changes with treatment outcomes.III. To evaluate the feasibility of measuring polo-like kinase 1 (Plk1) expression via immunohistochemistry (IHC) staining on archival tissues.OUTLINE:Patients receive tin Sn 117m DTPA intravenously (IV) over 5-10 minutes on day 1. Treatment repeats every 8 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive tin Sn 117m DTPA for an additional 2 cycles if pain recurs within 6 months after a 16-week pain observation period and no disease progression on bone scans, or evidence of clinical progression.After completion of study, patients are followed up every 4 weeks until week 28, and then every 3 months for up to 12 months after the first dose of tin Sn 117m DTPA..
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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 16. Apr. Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
610 |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: November 5, 2020, Last downloaded: ClinicalTrials.gov processed this data on April 24, 2024, Last updated: April 24, 2024 |
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| Study ID: |
NCT04616547 |
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| PPN (Katalog-ID): |
CTG003567087 |
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| 245 | 1 | 0 | |a Treatment of Cancer-Related Bone Pain by Using Bone-Targeted Radiation-Based Therapy (Sn-117m-DTPA) in Patients With Prostate Cancer That Has Spread to Bones |b A Single Arm Phase II Study of Bone-Targeted Sn-117m-DTPA in Symptomatic Castration Resistant Prostate Cancer With Skeletal Metastases |
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| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: November 5, 2020, Last downloaded: ClinicalTrials.gov processed this data on April 24, 2024, Last updated: April 24, 2024 | ||
| 520 | |a PRIMARY OBJECTIVE:I. To evaluate the efficacy of tin-117m diethylenetriaminepentaacetic acid (Sn-117m-DTPA) on sustained pain response in patients with castration-resistant prostate cancer (CRPC) metastatic to at least two bone sites with at least one clinically meaningful pain at baseline (>= 4 on an 11-point pain intensity scale).SECONDARY OBJECTIVES:I. To assess the safety and tolerability of Sn-117m-DTPA per Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.II. To measure Sn-117m-DTPA activity by gamma-camera dosimetry scans (serial full body planar images) obtained at 1 hour, 4 hours (or within 4-6 hours), 24 hours (or within 16-24 hours), 48 hours (or within 36-48 hours), 72 hours (or within 60-72 hours), 1 week (+/- 2 days), and 4 weeks (+/- 2 days) after the first Sn-117m-DTPA administration.III. To evaluate the therapeutic efficacy of Sn-117m-DTPA at 24 weeks as measured by Prostate Cancer Working Group 3 (PCWG3) criteria.IV. To evaluate time to the first symptomatic skeletal event defined as i) the first use of external-beam radiation therapy to relieve skeletal symptoms; ii) new symptomatic pathologic vertebral or nonvertebral bone fractures; iii) spinal cord compression; or iv) tumor-related orthopedic surgical intervention.V. To evaluate the overall pain response rate at 24 weeks. VI. To evaluate the duration of pain response defined as from the time of improvement in pain response (pain index =< 3) until the pain recurs.VII. To measure changes and time to progression in serum prostate-specific antigen (PSA) and serum alkaline phosphatase (ALP) levels.VIII. To measure patient-reported outcomes (PROs) and adverse events (AEs) (PRO-CTCAE) captured by digital instruments.IX. To evaluate progression-free survival (PFS) and overall survival (OS).EXPLORATORY OBJECTIVES:I. To examine any tumor genomic alterations that may be associated with response or resistance to Sn-117m-DTPA, a radiopharmaceutical agent.II. To examine the changes in systemic inflammatory markers (such as interferon [IFN]-gamma, tumor necrosis factor [TNF]-alpha, interleukins [IL]-8, IL-10, and IL-17) by flow cytometry, and changes in markers of immune function by measuring the percentage and absolute number of CD4+ T helper cells, CD8+ T cytotoxic cells, T regulatory cells, polymorphonuclear (PMN) myeloid-derived suppressor cells (MDSCs), and mononuclear MDSCs (M-MDSCs) prior to treatment versus (vs.) end of cycle 1, end of cycle 2, and at week 24 and correlate values and/or changes with treatment outcomes.III. To evaluate the feasibility of measuring polo-like kinase 1 (Plk1) expression via immunohistochemistry (IHC) staining on archival tissues.OUTLINE:Patients receive tin Sn 117m DTPA intravenously (IV) over 5-10 minutes on day 1. Treatment repeats every 8 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive tin Sn 117m DTPA for an additional 2 cycles if pain recurs within 6 months after a 16-week pain observation period and no disease progression on bone scans, or evidence of clinical progression.After completion of study, patients are followed up every 4 weeks until week 28, and then every 3 months for up to 12 months after the first dose of tin Sn 117m DTPA. | ||
| 650 | 2 | |a Prostatic Neoplasms | |
| 650 | 2 | |a Neoplasms | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Terminated | |
| 650 | 4 | |a Phase: Phase 2 | |
| 650 | 4 | |a 610 | |
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