Osteosarcoma Clinical Trial
Official title:
A Pilot Study of Pre-Operative Treatment of Newly-Diagnosed, Surgically-Resectable Osteosarcoma With Doxorubicin, Ifosfamide, Etoposide, and Cisplatin With Early Metabolic Assessment of Response
This is a pilot study that will allow investigators to collect data related to early and
potentially more accurate response assessments using a chemotherapy protocol that eliminates
methotrexate to maximize the dose intensity of doxorubicin. The pilot data will be used to
seek funding to more fully address the hypotheses in a multi-institutional, Phase II or
Phase III trial. The primary and secondary objectives are as follows:
Primary:
1. To evaluate the feasibility and potential usefulness of measuring early changes in
tumor metabolic activity, assessed by Fludeoxyglucose-Positron Emission Tomography
(FDG-PET) imaging and alkaline phosphatase activity, as early predictors of
histological response rate at 12 weeks in osteosarcoma patients.
2. To explore whether histological response can be assessed by a computer algorithm using
virtual microscopic images of pathology material, and whether quantifying necrosis in
this way correlates with microscope slide-based review.
Secondary:
1. To gather pilot data on the histological response rate, 3-year event-free survival, and
toxicity when children and young adults with resectable osteosarcoma are treated using a
chemotherapy regimen of alternating courses of doxorubicin/cisplatin (DC) and
doxorubicin/ifosfamide/etoposide (IDE).
All patients will receive 4 courses of preoperative chemotherapy courses. With the exception
of high-dose methotrexate, which is given weekly, preoperative and postoperative
chemotherapy courses are planned to begin every 21 days.
Patients with good histological response (those patients with > 90% tumor necrosis at time
of definitive resection) will receive three postoperative chemotherapy courses. The 1st will
consist of doxorubicin, dexrazoxane, cisplatin and Granulocyte-Colony Stimulating Factor
(G-CSF)(or Polyethylene Glycol filgrastim). The 2nd course will consist of doxorubicin,
dexrazoxane, ifosfamide, MESNA, etoposide, G-CSF (or PEG-filgrastim). The 3rd course will
consist of ifosfamide, MESNA, etoposide, G-CSF (or PEG-filgrastrim). The total doxorubicin
dose will be 450 mg/m2.
Patients with poor response (those patients with < 90% tumor necrosis found on pathology at
time of definitive resection) will receive five postoperative chemotherapy courses. High
Dose-Methotrexate will be administered during the 1st and 3rd postoperative chemotherapy
courses as 4-weekly and 2-weekly doses, respectively. The 2nd course will consist of
doxorubicin, dexrazoxane, cisplatin and G-CSF (or PEG-filgrastim). The 4th course will
consist of doxorubicin, dexrazoxane, ifosfamide, Mesna, etoposide, G-CSF (or
PEG-filgrastim). The 5th cycle will consist of ifosfamide, Mesna, etoposide, G-CSF (or
PEG-filgrastrim). The total doxorubicin dose will be 450 mg/m2.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00026780 -
Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
|
||
Not yet recruiting |
NCT05515068 -
Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas
|
||
Completed |
NCT02383901 -
A Retrospective Non-intervention Study to Characterize FOlate Rescue Treatment in Osteosarcoma Patients Treated With HDMTX
|
N/A | |
Active, not recruiting |
NCT01758666 -
A Clinical Research on the Relation of Blood Drug Concentration and Calcium Folinate Rescued in High-dose MTX Therapy
|
N/A | |
Completed |
NCT01674101 -
Effects of Preoperative Physical Therapy in Patients With Lower Extremity Malignancy
|
N/A | |
Completed |
NCT01615640 -
Diffusion Study on Patients With Osteosarcoma
|
||
Completed |
NCT00520936 -
A Study of Pemetrexed in Children With Recurrent Cancer
|
Phase 2 | |
Completed |
NCT00523419 -
Chemotherapy for Patients With Osteosarcoma
|
Phase 2 | |
Completed |
NCT00132158 -
ZD1839 and Oral Irinotecan in Treating Young Patients With Refractory Solid Tumors
|
Phase 1 | |
Not yet recruiting |
NCT04319874 -
Phase II Clinical Trial Scheme of Ganoderma Lucidum Spore Powder for Postoperative Chemotherapy of Osteosarcoma
|
Phase 2 | |
Recruiting |
NCT06029218 -
Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy
|
N/A | |
Recruiting |
NCT05642455 -
SPEARHEAD-3 Pediatric Study
|
Phase 1/Phase 2 | |
Recruiting |
NCT06117878 -
Safety and Efficacy of NK510 to Treat Osteosarcoma and Soft Tissue Sarcoma
|
Early Phase 1 | |
Not yet recruiting |
NCT04316091 -
A Phase I Clinical Trial of Neoadjuvant Chemotherapy With/Without SPIONs/SMF for Patients With Osteosarcoma
|
Phase 1 | |
Recruiting |
NCT03932058 -
Proteomics Research of Osteosarcoma
|
||
Withdrawn |
NCT01236586 -
RO4929097 in Children With Relapsed/Refractory Solid or CNS Tumors, Lymphoma, or T-Cell Leukemia
|
Phase 1 | |
Completed |
NCT00743496 -
A Phase I Trial Of The Humanized Anti-GD2 Antibody In Children And Adolescents With Neuroblastoma, Osteosarcoma, Ewing Sarcoma and Melanoma
|
Phase 1 | |
Recruiting |
NCT04040205 -
Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration
|
Phase 2 | |
Recruiting |
NCT05970497 -
A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT03628209 -
Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma
|
Phase 1/Phase 2 |