Osteosarcoma Clinical Trial
Official title:
Health Effects After Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-Related Cardiomyopathy
This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.
PRIMARY OBJECTIVES: I. To determine whether leukemia and lymphoma patients from P9404, P9425, P9426, and Dana Farber Cancer Institute (DFCI) 95-01 randomized to the experimental dexrazoxane hydrochloride (DRZ) arms have decreased markers of cardiomyopathy/heart failure (CHF) compared with patients on the standard arm. II. To determine whether osteosarcoma patients from P9754 (all received DRZ) have decreased markers of cardiomyopathy/heart failure (CHF) compared with similarly treated osteosarcoma patients diagnosed during the same time period, but who did not receive DRZ. III. To evaluate whether the cardioprotective effect of DRZ is modified by anthracycline (anthracycline analogue GPX-150) dose, chest radiation, and demographic factors (age at cancer diagnosis, current age, sex). SECONDARY OBJECTIVES: I. To determine whether leukemia and lymphoma patients from P9404, P9425, P9426, and DFCI 95-01 on the DRZ arms experienced differential rates of overall-survival and event-free survival compared with the standard therapy arms. II. To determine whether projected quality-adjusted life years (QALY) differed by DRZ status, accounting for premature cardiac disease, primary disease relapse, and second cancers. III. Determine the longitudinal trajectory of 2-dimensional echocardiographic parameters (focusing on left ventricular [LV] function and remodeling/geometric changes that can be reliably re-measured) among patients from time of cancer treatment through subsequent follow-up. OUTLINE: Patients complete a diagnostic symptom checklist, undergo a physical exam, echocardiogram, collection of serum for biomarker testing, and a 6 minute walk test, and complete quality of life, family history, physical activity, and smoking questionnaires. ;
| 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 |