Trial Outcomes & Findings for Samarium Sm 153 and Stem Cell Transplant Followed By Radiation Therapy Patients With Osteosarcoma (NCT NCT00245011)
NCT ID: NCT00245011
Last Updated: 2020-03-10
Results Overview
WHO (World Health Organization) tumor measurement criteria used to determine response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
1 week after study treatment
Results posted on
2020-03-10
Participant Flow
Participant milestones
| Measure |
Samarium-153/Stem Cell Transplant/Radiation
Samarium Sm153 Lexidronam Pentasodium (Samarium)/Stem Cell Transplant/Radiation arm: receive Ifosphamide IV in preparation for peripheral blood stem cell transplant followed by collection of stem cells. Samarium is administered after collection of peripheral blood stem cells (PBCT). Once counts recover, while receiving filgrastim daily, a second, higher dose of Samarium-153 is given, followed in 14 days by infusion of the stem cells.
Filgrastim: administered daily until count recovery Ifosfamide: administered as part of Stem Cell transplant preparation. PBCT: Before administration of Samarium, collection of autologous hematopoietic stem cells Radiation: Radiation Dosimetry performed at 4, 24, 48, and 72 after each infusion of Sm-EDTMP.
Samarium: First dose is administered after autologous stem cell collection. Second, higher dose, of SM-EDTMP administered after count recover. 14 days after administration of higher dose, patient undergoes autologous stem cell infusion.
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|---|---|
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Overall Study
STARTED
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11
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
|
1
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Reasons for withdrawal
| Measure |
Samarium-153/Stem Cell Transplant/Radiation
Samarium Sm153 Lexidronam Pentasodium (Samarium)/Stem Cell Transplant/Radiation arm: receive Ifosphamide IV in preparation for peripheral blood stem cell transplant followed by collection of stem cells. Samarium is administered after collection of peripheral blood stem cells (PBCT). Once counts recover, while receiving filgrastim daily, a second, higher dose of Samarium-153 is given, followed in 14 days by infusion of the stem cells.
Filgrastim: administered daily until count recovery Ifosfamide: administered as part of Stem Cell transplant preparation. PBCT: Before administration of Samarium, collection of autologous hematopoietic stem cells Radiation: Radiation Dosimetry performed at 4, 24, 48, and 72 after each infusion of Sm-EDTMP.
Samarium: First dose is administered after autologous stem cell collection. Second, higher dose, of SM-EDTMP administered after count recover. 14 days after administration of higher dose, patient undergoes autologous stem cell infusion.
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Overall Study
Lack of Efficacy
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1
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Baseline Characteristics
Samarium Sm 153 and Stem Cell Transplant Followed By Radiation Therapy Patients With Osteosarcoma
Baseline characteristics by cohort
| Measure |
Samarium-153/Stem Cell Transplant/Radiation
n=11 Participants
Samarium Sm153 Lexidronam Pentasodium/Stem Cell Transplant/Radiation arm will receive Ifosphamide IV in preparation for peripheral blood stem cell transplant followed by stem cell collection. Samarium Sm153 Lexidronam Pentasodium is administered after collection of peripheral blood stem cells. Once counts recover, while receiving filgrastim daily, a 2nd, higher dose of Samarium-153 is given, followed in 14 days by stem cell infusion.
Filgrastim: Filgrastim will be administered every day til count recovery Ifosfamide: Ifosfamide will be administered as part of Stem Cell transplant prep.
Peripheral blood stem cell transplantation: Before administration of Samarium, collection of autologous hematopoietic stem cells Radiation: Radiation Dosimetry performed at 4, 24, 48, and 72 after each infusion of Sm-EDTMP.
Samarium Sm 153 lexidronam pentasodium: First dose of Sm-EDTMP administered after autologous stem cell collection. Second, higher dose, of SM-EDTMP administered 7 days later.
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Age, Categorical
<=18 years
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6 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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5 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Age, Continuous
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18 years
n=5 Participants
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Sex: Female, Male
Female
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5 Participants
n=5 Participants
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Sex: Female, Male
Male
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6 Participants
n=5 Participants
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Region of Enrollment
United States
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11 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 1 week after study treatmentPopulation: 11 subjects, heavily treated with chemotherapy with osteosarcoma metastatic to bone were enrolled; 10 evaluable for response.
WHO (World Health Organization) tumor measurement criteria used to determine response.
Outcome measures
| Measure |
Samarium-153/Stem Cell Transplant/Radiation
n=10 Participants
Samarium Sm153 Lexidronam Pentasodium (\^153Sm-EDTMP)/Stem Cell Transplant/Radiation arm will receive Ifosphamide IV in preparation for peripheral blood stem cell transplant followed by stem cell harvest. \^153Sm-EDTMP is administered after collection of peripheral blood stem cells. Once counts recover, while receiving filgrastim daily, a 2nd, higher dose of \^153Sm-EDTMP is given, followed in 14 days by stem cell infusion.
filgrastim: Filgrastim is administered every day til count recovery.
ifosfamide: Ifosfamide is administered as part of Stem Cell transplant prep.
peripheral blood stem cell harvesting: completed before administration of \^153Sm-EDTMP, collection of autologous hematopoietic stem cells.
radiation: Radiation Dosimetry performed at 4, 24, 48, and 72 after each infusion of \^153Sm-EDTMP.
\^153Sm-EDTMP: First dose is administered after autologous stem cell collection. Second, higher dose, is administered 1 week later.
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Tumor Response
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10 participants
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SECONDARY outcome
Timeframe: At Time of Tumor ResectionPopulation: The PI has left the institution and the only access to the data is from publications. The access to this specific information/data cannot be confirmed and is not available to be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 4 yearsOutcome measures
| Measure |
Samarium-153/Stem Cell Transplant/Radiation
n=11 Participants
Samarium Sm153 Lexidronam Pentasodium (\^153Sm-EDTMP)/Stem Cell Transplant/Radiation arm will receive Ifosphamide IV in preparation for peripheral blood stem cell transplant followed by stem cell harvest. \^153Sm-EDTMP is administered after collection of peripheral blood stem cells. Once counts recover, while receiving filgrastim daily, a 2nd, higher dose of \^153Sm-EDTMP is given, followed in 14 days by stem cell infusion.
filgrastim: Filgrastim is administered every day til count recovery.
ifosfamide: Ifosfamide is administered as part of Stem Cell transplant prep.
peripheral blood stem cell harvesting: completed before administration of \^153Sm-EDTMP, collection of autologous hematopoietic stem cells.
radiation: Radiation Dosimetry performed at 4, 24, 48, and 72 after each infusion of \^153Sm-EDTMP.
\^153Sm-EDTMP: First dose is administered after autologous stem cell collection. Second, higher dose, is administered 1 week later.
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Overall and Progression-free Survival After Study Treatment
Overall Survival
|
NA days
The PI has left the institution and the only access to the data is from publications. The access to this specific information/data cannot be confirmed and is not available to be reported
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Overall and Progression-free Survival After Study Treatment
Progression-free Survival
|
79 days
The PI has left the institution and the only access to the data is from publications. The access to this specific information/data cannot be confirmed and is not available to be reported
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SECONDARY outcome
Timeframe: Continual and at End of StudyOutcome measures
| Measure |
Samarium-153/Stem Cell Transplant/Radiation
n=11 Participants
Samarium Sm153 Lexidronam Pentasodium (\^153Sm-EDTMP)/Stem Cell Transplant/Radiation arm will receive Ifosphamide IV in preparation for peripheral blood stem cell transplant followed by stem cell harvest. \^153Sm-EDTMP is administered after collection of peripheral blood stem cells. Once counts recover, while receiving filgrastim daily, a 2nd, higher dose of \^153Sm-EDTMP is given, followed in 14 days by stem cell infusion.
filgrastim: Filgrastim is administered every day til count recovery.
ifosfamide: Ifosfamide is administered as part of Stem Cell transplant prep.
peripheral blood stem cell harvesting: completed before administration of \^153Sm-EDTMP, collection of autologous hematopoietic stem cells.
radiation: Radiation Dosimetry performed at 4, 24, 48, and 72 after each infusion of \^153Sm-EDTMP.
\^153Sm-EDTMP: First dose is administered after autologous stem cell collection. Second, higher dose, is administered 1 week later.
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Toxicity at End of Study Treatment
Delayed numbness and tingling
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3 Participants
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Toxicity at End of Study Treatment
Mild hypocalcemia
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1 Participants
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Toxicity at End of Study Treatment
Mild - Moderate pancytopenia
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11 Participants
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Toxicity at End of Study Treatment
Lymphopenia
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11 Participants
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Toxicity at End of Study Treatment
Fever
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5 Participants
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SECONDARY outcome
Timeframe: ContinualPopulation: The PI has left the institution and the only access to the data is from publications. The access to this specific information/data cannot be confirmed and is not available to be reported
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: completion of treatmentPopulation: The PI has left the institution and the only access to the data is from publications. The access to this specific information/data cannot be confirmed and is not available to be reported
Outcome measures
Outcome data not reported
Adverse Events
Samarium-153
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Samarium-153
n=11 participants at risk
Cytoxan+Ifosfamide, Filgrastim pre samarium.'Sm-EDTMP (low dose). once counts recover, Sm-EDTMP (high dose) given. Peripheral blood stem cell transplantation is done 14 days later.
filgrastim: Filgrastim will be administered post post chemotherapy until target WBC count is achieved.
ifosfamide: Ifosfamide administered IV.
peripheral blood stem cell transplantation: Peripheral blood stem cell transplantation is done 14 days after 2nd dose of Samarium is delivered
Sm-EDTMP (low dose): Sm-EDTMP (low dose) administered after autologous stem cell collection
sm-EDTMP (higher dose): Upon blood cell count recovery from Sm-EDTMP (low dose), Sm-EDTMP (higher dose) is administered followed in 14 days by peripheral blood stem cell transplantation.
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Blood and lymphatic system disorders
Low Platelets
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72.7%
8/11 • Number of events 8 • 6 weeks; the dose limiting toxicity was defined to be recovery of blood counts by 6 weeks post treatment with SmEDTMP (higher dose). Subjects continued to be monitored until count recovery and indefinitely for survival.
The PI has left the institution and the only access to the data is from publications. The access to all-cause mortality data cannot be confirmed and is not available to be reported.
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Blood and lymphatic system disorders
Neutorpenia
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72.7%
8/11 • Number of events 8 • 6 weeks; the dose limiting toxicity was defined to be recovery of blood counts by 6 weeks post treatment with SmEDTMP (higher dose). Subjects continued to be monitored until count recovery and indefinitely for survival.
The PI has left the institution and the only access to the data is from publications. The access to all-cause mortality data cannot be confirmed and is not available to be reported.
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Blood and lymphatic system disorders
Anemia
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90.9%
10/11 • Number of events 10 • 6 weeks; the dose limiting toxicity was defined to be recovery of blood counts by 6 weeks post treatment with SmEDTMP (higher dose). Subjects continued to be monitored until count recovery and indefinitely for survival.
The PI has left the institution and the only access to the data is from publications. The access to all-cause mortality data cannot be confirmed and is not available to be reported.
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Respiratory, thoracic and mediastinal disorders
pleural effusion
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9.1%
1/11 • Number of events 1 • 6 weeks; the dose limiting toxicity was defined to be recovery of blood counts by 6 weeks post treatment with SmEDTMP (higher dose). Subjects continued to be monitored until count recovery and indefinitely for survival.
The PI has left the institution and the only access to the data is from publications. The access to all-cause mortality data cannot be confirmed and is not available to be reported.
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Metabolism and nutrition disorders
Hyponatremia
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9.1%
1/11 • Number of events 1 • 6 weeks; the dose limiting toxicity was defined to be recovery of blood counts by 6 weeks post treatment with SmEDTMP (higher dose). Subjects continued to be monitored until count recovery and indefinitely for survival.
The PI has left the institution and the only access to the data is from publications. The access to all-cause mortality data cannot be confirmed and is not available to be reported.
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Additional Information
David M. Loeb, M.D., Ph.D., Director, Musculoskeletal Tumor Program
Sidney Kimmel Comprehensive Cancer Center
Phone: 410.502.7247
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place