A Phase 2 interventional study of filgrastim and ifosfamide in Sarcoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Completed at 1 site in United States. Open to participants aged 13 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-03-10.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Phase 2, Interventional, and Treatment
RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to tumor cells and not harm normal cells. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and samarium Sm 153 lexidronam pentasodium. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving samarium Sm 153 lexidronam pentasodium together with a peripheral stem cell transplant and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving samarium Sm 153 lexidronam pentasodium together with autologous stem cell transplant and radiation therapy works in treating patients with recurrent or refractory, metastatic, or unresectable osteosarcoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to resectability of the primary tumor (recurrent, refractory, or very high-risk disease vs unresectable primary tumor).
NOTE: *Patients who have undergone PBSC collection before study entry proceed to high-dose samarium Sm 153 lexidronam pentasodium (153Sm-EDTMP) infusion without mobilization and collection of autologous PBSCs.
NOTE: **Patients may receive the trace dose on protocol JHOC (Johns Hopkins Oncology Center)-J0094.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's enrollment of 11 is below the median of 40 across 1,283 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 572 studies on the registry; 73 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 67 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diagnosis of osteosarcoma
High-risk disease, meeting 1 of the following criteria:
Exclusion
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.
Biological: filgrastim · Drug: ifosfamide · Procedure: peripheral blood stem cell transplantation · Radiation: Sm-EDTMP (low dose) · Radiation: sm-EDTMP (higher dose)
Filgrastim will be administered post post chemotherapy until target WBC (white blood cell) count is achieved.
Also known as: Neupogen
Ifosfamide administered IV.
Also known as: Ifex
Peripheral blood stem cell transplantation is done 14 days after 2nd dose of Samarium is delivered
Sm-EDTMP (low dose) administered after autologous stem cell collection
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.
Tumor Response
WHO (World Health Organization) tumor measurement criteria used to determine response.
Time frame: 1 week after study treatment
Predictive Value of Imaging Studies
Time frame: At Time of Tumor Resection
Overall and Progression-free Survival After Study Treatment
Time frame: up to 4 years
Toxicity at End of Study Treatment
Time frame: Continual and at End of Study
Long Term Side Effects of Infusional Samarium-153 After Study Treatment
Time frame: Continual
Correlative Dose of Radiation by Low Dose and High Dose Samarium-153
Time frame: completion of treatment
| Milestone | Samarium-153/Stem Cell Transplant/Radiation |
|---|---|
| Started | 11 |
| Completed | 10 |
| Not completed | 1 |
| Withdrew: Lack of efficacy | 1 |
WHO (World Health Organization) tumor measurement criteria used to determine response.
| participants | Samarium-153/Stem Cell Transplant/Radiation |
|---|---|
| Tumor Response | 10 |
No measurements were reported for this outcome.
| days | Samarium-153/Stem Cell Transplant/Radiation |
|---|---|
| Overall Survival | NA (NA to NA) |
| Progression-free Survival | 79 (NA to NA) |
| Participants | Samarium-153/Stem Cell Transplant/Radiation |
|---|---|
| Delayed numbness and tingling | 3 |
| Mild hypocalcemia | 1 |
| Mild - Moderate pancytopenia | 11 |
| Lymphopenia | 11 |
| Fever | 5 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Samarium-153 | — | 0/11 (0%) | 10/11 (90.9%) |
| Event | Samarium-153 |
|---|---|
| AnemiaBlood and lymphatic system disorders | 10/11 |
| Low PlateletsBlood and lymphatic system disorders | 8/11 |
| NeutorpeniaBlood and lymphatic system disorders | 8/11 |
| pleural effusionRespiratory, thoracic and mediastinal disorders | 1/11 |
| HyponatremiaMetabolism and nutrition disorders | 1/11 |
| Age, Categorical(Participants) | Samarium-153/Stem Cell Transplant/Radiation |
|---|---|
| <=18 years | 6 |
| Between 18 and 65 years | 5 |
| >=65 years | 0 |
| Age, Continuous(years) | Samarium-153/Stem Cell Transplant/Radiation |
|---|---|
| Median | 18 (14 to 30) |
| Sex: Female, Male(Participants) | Samarium-153/Stem Cell Transplant/Radiation |
|---|---|
| Female | 5 |
| Male | 6 |
| Region of Enrollment(Participants) | Samarium-153/Stem Cell Transplant/Radiation |
|---|---|
| United States | 11 |
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins