Sarcoma Clinical Trial
Official title:
Feasibility and Dose Discovery Analysis of Zoledronic Acid With Concurrent Chemotherapy in the Treatment of Newly Diagnosed Metastatic Osteosarcoma
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor
cells, either by killing the cells or by stopping them from dividing. Giving more than one
drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This clinical trial is studying the side effects and best dose of zoledronic acid
when given together with combination chemotherapy in treating patients with newly diagnosed
metastatic osteosarcoma.
OBJECTIVES:
Primary:
- To assess the feasibility and safety of zoledronic acid when administered in
combination with standard chemotherapy in patients with newly diagnosed metastatic
osteosarcoma.
- To determine the maximum tolerated dose of zoledronic acid when administered in
combination with standard chemotherapy in these patients.
Secondary:
- To compare the histologic response and event-free survival of patients treated with this
regimen versus patients treated on INT-0133 or CCG-7943.
OUTLINE: This is a multicenter, dose-escalation study of zoledronic acid.
- Induction therapy (weeks 1-11): Patients receive dexrazoxane hydrochloride IV slowly
over 5-15 minutes, doxorubicin hydrochloride IV over 15 minutes, and cisplatin IV over
1 hour on days 1 and 2 of weeks 1 and 6; zoledronic acid IV at the assigned dose level
over 30 minutes on day 4 of weeks 1 and 6; high-dose methotrexate IV over 4 hours on
day 1 of weeks 4, 5, 9, and 10; leucovorin calcium IV or orally every 6 hours starting
on day 2 and continuing until clearance of methotrexate of weeks 4, 5, 9, and 10; and
filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 3 of weeks 1 and 6
and continuing until blood counts recover.
- Surgery (week 12): Patients undergo definitive surgery (limb-salvage surgery or
amputation) of the primary tumor in week 12.
- Maintenance therapy course 1 (weeks 13-25): Patients receive etoposide IV over 1 hour
and ifosfamide IV over 4 hours on days 1-5 of weeks 13 and 21; zoledronic acid IV over
30 minutes on day 4 of week 17 and on day 7 of weeks 13 and 21; high-dose methotrexate
IV over 4 hours on day 1 of weeks 16, 20, and 24; leucovorin calcium IV or orally every
6 hours starting on day 2 and continuing until clearance of methotrexate of weeks 16,
20, and 24; dexrazoxane hydrochloride IV slowly over 5-15 minutes, doxorubicin
hydrochloride IV over 15 minutes, and cisplatin IV over 1 hour on days 1 and 2 of week
17; and G-CSF SC once daily beginning on day 6 of weeks 13, 17, and 21 and continuing
until blood counts recover.
- Surgery (week 26): Patients may undergo surgical resection of primary metastases in
week 26.
- Maintenance therapy course 2 (weeks 27-36): Patients receive dexrazoxane hydrochloride
IV slowly over 5-15 minutes and doxorubicin hydrochloride IV over 15 minutes on days 1
and 2 of weeks 27 and 31; cisplatin IV over 1 hour on days 1 and 2 of week 27;
zoledronic acid IV over 30 minutes on day 4 of week 27 and on day 7 of weeks 31 and 36;
high-dose methotrexate IV over 4 hours on day 1 of weeks 30, 34, and 35; leucovorin
calcium IV or orally every 6 hours starting on day 2 and continuing until clearance of
methotrexate of weeks 30, 34, and 35; etoposide IV over 1 hour on days 1-5 of week 36;
ifosfamide (1.8 gm/m2 ) IV over 1 hour on days 1-5 of week 31;ifosfamide (2.8 gm/m2)IV
over 4 hours on days 1-5 of week 36; and G-CSF SC once daily beginning on day 3 of
weeks 27, 31, and 36 and continuing until blood counts recover.
Mensa is a supportive care medicine used to prevent hemorrhagic cystitis caused by
ifosfamide. It is always given when ifosfamide is given. It was used in all arms.
After completion of study treatment, patients are followed periodically for up to 5 years.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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