Trial Outcomes & Findings for Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma (NCT NCT01886105)

NCT ID: NCT01886105

Last Updated: 2019-10-29

Results Overview

Percentage of patients with high-risk osteogenic sarcoma, treated with high-dose Samarium-153 EDTMP and external beam radiotherapy, without progression at 6 months.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 4 participants
• Primary outcome timeframe: 6 months post-intervention
• Results posted on: 2019-10-29

Participant Flow

Participant milestones

Measure	SmEDTMP/Autologous Stem Cell Infusion/RT Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy to be delivered according to the judgement of the treating radiation oncologist.
Overall Study STARTED	4
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure

SmEDTMP/Autologous Stem Cell Infusion/RT Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy to be delivered according to the judgement of the treating radiation oncologist.

Overall Study Lack of Efficacy

3

Baseline Characteristics

Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma

Baseline characteristics by cohort

Measure	SmEDTMP/Autologous Stem Cell Infusion/RT n=4 Participants Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy will be delivered according to the judgement of the treating radiation oncologist.
Age, Categorical <=18 years	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	23 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months post-intervention

Percentage of patients with high-risk osteogenic sarcoma, treated with high-dose Samarium-153 EDTMP and external beam radiotherapy, without progression at 6 months.

Outcome measures

Measure

SmEDTMP/Autologous Stem Cell Infusion/RT n=4 Participants Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy will be delivered according to the judgement of the treating radiation oncologist.

Percentage of Treated Participants With 6-month Progression Free Survival

0 Participants

SECONDARY outcome

Timeframe: Up to 48 months

Number of patients experiencing any Grade 3-4 toxicity, as defined by CTCAE v4.0 and RTOG Cooperative Group Common Toxicity Criteria, during the trial intervention and follow-up.

Outcome measures

Measure

SmEDTMP/Autologous Stem Cell Infusion/RT n=4 Participants Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy will be delivered according to the judgement of the treating radiation oncologist.

Short and Long-term Side Effects of Combined Infusional Samarium-153 EDTMP and External Beam Radiotherapy as Assessed by Number of Participants With Toxicity

4 Participants

Adverse Events

SmEDTMP/Autologous Stem Cell Infusion/RT

Serious events: 3 serious events

Other events: 4 other events

Deaths: 4 deaths

Serious adverse events

Measure	SmEDTMP/Autologous Stem Cell Infusion/RT n=4 participants at risk Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy will be delivered according to the judgement of the treating radiation oncologist.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hospitalization	25.0% 1/4 • Number of events 1 • up to 4 months No patients who enrolled on the trial survived longer than 4 months. Toxicities were graded according to CTCAE v4.0 and the RTOG Cooperative Group Common Toxicity Criteria, and attributable toxicities grade 3 or higher were recorded.
Respiratory, thoracic and mediastinal disorders Hospitalization	50.0% 2/4 • Number of events 2 • up to 4 months No patients who enrolled on the trial survived longer than 4 months. Toxicities were graded according to CTCAE v4.0 and the RTOG Cooperative Group Common Toxicity Criteria, and attributable toxicities grade 3 or higher were recorded.
Respiratory, thoracic and mediastinal disorders Hospitalization/Death	25.0% 1/4 • Number of events 1 • up to 4 months No patients who enrolled on the trial survived longer than 4 months. Toxicities were graded according to CTCAE v4.0 and the RTOG Cooperative Group Common Toxicity Criteria, and attributable toxicities grade 3 or higher were recorded.

Other adverse events

Measure	SmEDTMP/Autologous Stem Cell Infusion/RT n=4 participants at risk Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy will be delivered according to the judgement of the treating radiation oncologist.
Gastrointestinal disorders Nausea	50.0% 2/4 • Number of events 2 • up to 4 months No patients who enrolled on the trial survived longer than 4 months. Toxicities were graded according to CTCAE v4.0 and the RTOG Cooperative Group Common Toxicity Criteria, and attributable toxicities grade 3 or higher were recorded.
Blood and lymphatic system disorders Anemia	50.0% 2/4 • Number of events 3 • up to 4 months No patients who enrolled on the trial survived longer than 4 months. Toxicities were graded according to CTCAE v4.0 and the RTOG Cooperative Group Common Toxicity Criteria, and attributable toxicities grade 3 or higher were recorded.
Blood and lymphatic system disorders Thrombocytopenia	50.0% 2/4 • Number of events 3 • up to 4 months No patients who enrolled on the trial survived longer than 4 months. Toxicities were graded according to CTCAE v4.0 and the RTOG Cooperative Group Common Toxicity Criteria, and attributable toxicities grade 3 or higher were recorded.
Psychiatric disorders Pain	25.0% 1/4 • Number of events 6 • up to 4 months No patients who enrolled on the trial survived longer than 4 months. Toxicities were graded according to CTCAE v4.0 and the RTOG Cooperative Group Common Toxicity Criteria, and attributable toxicities grade 3 or higher were recorded.

Additional Information

Dr. Brian H. Ladle

Johns Hopkins University

Phone: 443-287-3534

Email: bladle@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place