High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma

BTG

Status and phase: Terminated; Phase 2

Conditions: Osteosarcoma

Treatments: Drug: leucovorin; Drug: glucarpidase

Study type: Interventional

Funder types: Other

Identifiers

NCT00634322

PR001-CLN-pro012

MDACC #2006-0246

Details and patient eligibility

About

The purpose of this study is to demonstrate whether use of glucarpidase facilitates administration of the next cycle of chemotherapy as scheduled and improves safety and tolerability of HDMTX given with LV

Enrollment: 7 patients

Sex: All

Ages: 8 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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7 participants in 3 patient groups

A

Experimental group

Description:

HDMTX-LV with glucarpidase

Treatment:

Drug: glucarpidase

B

Active Comparator group

Description:

HDMTX-LV with placebo

Treatment:

Drug: leucovorin

C

Experimental group

Description:

compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment

Treatment:

Drug: glucarpidase