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Randomized, Blinded, Placebo-Controlled Trial of High Dose Methotrexate With Leucovorin Rescue (HDMTX-LV) With or Without Glucarpidase in Osteosarcoma


Phase 2
8 Years
50 Years
Not Enrolling
Both
Osteosarcoma

Thank you

Trial Information

Randomized, Blinded, Placebo-Controlled Trial of High Dose Methotrexate With Leucovorin Rescue (HDMTX-LV) With or Without Glucarpidase in Osteosarcoma


Inclusion Criteria:



- osteosarcoma

- eligible to receive 2 sequential cycles of HDMTX-LV

Exclusion Criteria:

- prior administration of glucarpidase

- progression of disease while on previous MTX treatment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Outcome Measure:

successful advancement to the next cycle of chemotherapy at scheduled time

Outcome Time Frame:

one week

Safety Issue:

No

Principal Investigator

Pete Anderson, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

PR001-CLN-pro012

NCT ID:

NCT00634322

Start Date:

October 2008

Completion Date:

April 2009

Related Keywords:

  • Osteosarcoma
  • osteosarcoma
  • high dose methotrexate
  • leucovorin
  • Osteosarcoma

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