- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03612466
A Dose Finding Study of CycloSam® Combined With External Beam Radiotherapy
A Dose Finding Study of CycloSam® (153Sm-DOTMP) Combined With External Beam Radiotherapy to Treat High Risk Osteosarcoma and Other Solid Tumors Metastatic to Bone
Study Overview
Status
Conditions
Detailed Description
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
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New York
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Bronx, New York, United States, 10461
- Montefiore Medical Center-Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically confirmed diagnosis of a solid tumor metastatic to bone, or a histologically confirmed diagnosis of osteosarcoma with either an unresectable primary tumor or metastases (including tumors with an intralesional resection).
- Measurable disease on anatomic imaging that is also avid for phosphonate compounds as demonstrated by a positive 99mTc diphosphonate bone scan.
- Adequate renal function, defined as a measured creatinine clearance >70 ml/min/1.73 m2 or normal radioisotope glomerular filtration rate (GFR).
- Adequate hematologic function, defined as a platelet count > 50,000 cells/mm3 and an absolute neutrophil count (ANC) > 500 cells/mm3
- Life expectancy of at least 8 weeks.
- Karnofsky performance status > 50%
- Subject must have adequately recovered from the effects of any prior chemotherapy, as determined by the treating physician and study team, based in part on organ function defined above. Toxicities from previous therapies must have recovered to Common Terminology Criteria for Adverse Events (CTCAE) 4.0 grade 2 or better.
- Patients must have previously received effective treatment for their underlying disease and have no potentially curative options available.
Exclusion Criteria:
- Subject has received prior radiotherapy to all known areas of current active disease or has a known contraindication to receiving radiotherapy.
- Subject is pregnant or breastfeeding.
- Patient is sexually active and does not agree to use accepted, effective forms of contraception.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Dose Escalation Arm
Dose Levels 1-3 will consist of treatment with radiopharmaceutical (153Sm-DOTMP) alone. If the maximally tolerated dose (MTD) has not been reached at Level 3, external beam radiotherapy will be added to each of Levels 4-6. Participants enrolled on Dose Levels 4-6 will be treated with external beam radiotherapy to all radiographically evident sites of disease. If an MTD has not been determined at Level 6, the study will end and Dose Level 6 will be declared the Recommended Phase 2 Dose. Participants will be given prophylactic / supportive treatment protocols including Calcium Carbonate, mozobil, and neupogen injectable product. |
For Levels 1- 3, the Day 1 dosages will be the same (0.5 millicurie (mCi)/kg 153Sm-DOTMP) for all levels but the Day 8 dosages will be 0.5, 1.0 and 3.0 mCi/kg respectively.
For Levels 4, 5 & 6, the Day 1 dosages will be the same (0.5 mCi/kg 153Sm-DOTMP) for all levels but the Day 8 dosages will be 3, 6, then 10 mCi/kg 153Sm-DOTMP respectively.
Other Names:
The amount of radiation will be determined based on how much radiation was delivered to each tumor by the 153Sm-DOTMP, and will be targeted to 70 Gray (Gy)
Calcium carbonate will be given to participants as prophylaxis against hypocalcemia..
Participants who require stem cell collection will be given Mozobil to help mobilize hematopoietic stem cells into the circulation for collection.
Other Names:
Participants who require stem cell collection will be given Neupogen to help mobilize hematopoietic stem cells into the circulation for collection.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximally Tolerated Dose
Time Frame: MTD will be determined based on DLTs experienced by participants during the first 42 days after administration of 153Sm-DOTMP for Dose Levels 1-3 and during the first 70 days after administration for Dose Levels 4-6
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The maximally tolerated dose (MTD) of 153Sm-DOTMP will be determined.
The MTD will be defined as the dose that produces a dose limiting toxicity (DLT) in 30% of the participants.
The dose limiting toxicity is the dosage at which side effects are serious enough to prevent an increase in dose or level of that treatment.
DLTs will be defined as any grade 3, 4, or 5 non-hematologic toxicity experienced during a 42-70 day observation window.
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MTD will be determined based on DLTs experienced by participants during the first 42 days after administration of 153Sm-DOTMP for Dose Levels 1-3 and during the first 70 days after administration for Dose Levels 4-6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: From date of enrollment until date of death from any cause, assessed up to 60 months
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The overall survival of participants with bone metastatic osteosarcoma will be determined.
Overall survival is defined as the time from enrollment in the study until death.
Observation begins at study enrollment and terminates upon death of the subject.
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From date of enrollment until date of death from any cause, assessed up to 60 months
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Time To Progression
Time Frame: Participants will be evaluated 4, 8, and 12 months after treatment.
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The time to progression of participants with bone metastatic osteosarcoma will be determined.
Time to progression is defined as the time from study enrollment until the first radiographic evidence of progressive disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST).
RECIST is a set of published rules that help define whether cancer patients improve, stay the same, or get worse with treatment.
This study uses the revised RECIST 1.1 guidelines.
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Participants will be evaluated 4, 8, and 12 months after treatment.
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Clinical Response Rate 30 days post treatment
Time Frame: 30 days post treatment
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Participants will undergo radiographic evaluation 30 days after completion of all protocol therapy.
The response of each tumor to treatment will be determined based on RECIST 1.1 criteria.
Clinical response will be defined as either stable disease or a decrease in the size of the tumor by radiographic imaging (which may include CT or MRI) using RECIST 1.1 criteria.
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30 days post treatment
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Clinical Response Rate 4 months post treatment
Time Frame: 4 months post treatment
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Participants will undergo radiographic evaluation 4 months after completion of all protocol therapy.
The response of each tumor to treatment will be determined based on RECIST 1.1 criteria.
Clinical response will be defined as either stable disease or a decrease in the size of the tumor by radiographic imaging (which may include CT or MRI) using RECIST 1.1 criteria.
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4 months post treatment
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Clinical Response Rate 8 months post treatment
Time Frame: 8 months post treatment
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Participants will undergo radiographic evaluation 8 months after completion of all protocol therapy.
The response of each tumor to treatment will be determined based on RECIST 1.1 criteria.
Clinical response will be defined as either stable disease or a decrease in the size of the tumor by radiographic imaging (which may include CT or MRI) using RECIST 1.1 criteria
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8 months post treatment
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Clinical Response Rate 12 months post treatment
Time Frame: 12 months post treatment
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Participants will undergo radiographic evaluation 12 months after completion of all protocol therapy.
The response of each tumor to treatment will be determined based on RECIST 1.1 criteria.
Clinical response will be defined as either stable disease or a decrease in the size of the tumor by radiographic imaging (which may include CT or MRI) using RECIST 1.1 criteria.
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12 months post treatment
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: David Loeb, MD, PhD, Children's Hospital at Montefiore
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Bone Tissue
- Neoplasms, Connective Tissue
- Sarcoma
- Osteosarcoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Gastrointestinal Agents
- Calcium-Regulating Hormones and Agents
- Antacids
- Calcium
- Calcium Carbonate
- Plerixafor
Other Study ID Numbers
- 2018-8787
- 7R01CA163870-06 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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