Metastatic Osteosarcoma
Conditions
Keywords
Osteosarcoma, Osteogenic Sarcoma, Sarcoma, Bone Cancer
Brief summary
The primary goal of this study will be to examine tumor response after radiation treatment via a combination of Samarium-153 EDTMP and external beam radiotherapy.
Detailed description
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.
Interventions
DRUGSm-EDTMP
Subjects receive a tracer infusion of Samarium-153 EDTMP at 1 mCi/kg. 3D dosimetry using SPECT images are obtained post tracer infusion to determine the distribution of dose delivered to the tumor and surrounding normal tissues. Tracer activity will be applied to development of the external beam radiation (EBT) planning. Second treatment infusion of Samarium will then be implemented. Maximum activity administered will be 30 mCi/kg.
Administered 14 days after Treatment infusion of Samarium-153 EDTMP.
RADIATIONExternal Beam Radiotherapy
The radiotherapy portion of the combined plan will be delivered according to the judgement of the treating radiation oncologist. The total dose to be used will be modified based on surrounding tissue tolerances as evidenced by Samarium infusion and SPECT image planning. After the treatment infusion, SPECT scans will again be performed to confirm the total dose delivered and subsequently adjust the EBT portion of the treatment plan, as necessary.
Sponsors
National Cancer Institute (NCI)
Jazz Pharmaceuticals
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients must be between 13 and 65 years of age, inclusive * Must have unresectable primary tumor or metastases * Must have measurable disease that is demonstrated by positive Tc-99m Bone Scan. Not all lesions must be positive on bone scan. * Creatinine clearance \>70ml/min/1.73m2 * ANC \>500/mm3 * Platelets \>50,000/mm3 * Life expectancy \> 8 weeks * Karnofsky performance status \>50% * Stem cell product collected prior to the infusion of Samarium must be available, either by peripheral stem cell mobilization or bone marrow harvest prior to trial entry.
Exclusion criteria
* Patient may not be pregnant or breastfeeding. * Patients who have received prior radiotherapy to all areas of current active disease are not eligible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Treated Participants With 6-month Progression Free Survival | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short and Long-term Side Effects of Combined Infusional Samarium-153 EDTMP and External Beam Radiotherapy as Assessed by Number of Participants With Toxicity | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 will be delivered according to the judgement of the treating radiation oncologist. | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 3 |
Baseline characteristics
| Characteristic | SmEDTMP/Autologous Stem Cell Infusion/RT |
|---|---|
| Age, Categorical <=18 years | 2 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 23 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 4 |
| other Total, other adverse events | 4 / 4 |
| serious Total, serious adverse events | 3 / 4 |
Outcome results
Primary
Percentage of Treated Participants With 6-month Progression Free Survival
Percentage of patients with high-risk osteogenic sarcoma, treated with high-dose Samarium-153 EDTMP and external beam radiotherapy, without progression at 6 months.
Time frame: 6 months post-intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SmEDTMP/Autologous Stem Cell Infusion/RT | Percentage of Treated Participants With 6-month Progression Free Survival | 0 Participants |
Secondary
Short and Long-term Side Effects of Combined Infusional Samarium-153 EDTMP and External Beam Radiotherapy as Assessed by Number of Participants With Toxicity
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.
Time frame: Up to 48 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SmEDTMP/Autologous Stem Cell Infusion/RT | 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 |