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| Sponsors and Collaborators: |
Protherics M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | Protherics |
| ClinicalTrials.gov Identifier: | NCT00634322 |
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Osteosarcoma |
Drug: glucarpidase Drug: leucovorin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Randomized, Blinded, Placebo-Controlled Trial of High Dose Methotrexate With Leucovorin Rescue (HDMTX-LV) With or Without Glucarpidase in Osteosarcoma |
| Enrollment: | 8 |
| Study Start Date: | October 2008 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
HDMTX-LV with glucarpidase
|
Drug: glucarpidase
IV dose based on weight, two doses given for 5 minutes, 24 hours apart
|
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B: Active Comparator
HDMTX-LV with placebo
|
Drug: leucovorin
IV or po given every 6 hours
|
|
C: Experimental
compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment
|
Drug: glucarpidase
IV dose based on weight, two doses given for 5 minutes, 24 hours apart
|
Eligibility| Ages Eligible for Study: | 8 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Pete Anderson, MD, PhD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center ( Peter M. Anderson, MD, PhD/Principal Investigator ) |
| Study ID Numbers: | PR001-CLN-pro012, MDACC #2006-0246 |
| Study First Received: | March 6, 2008 |
| Last Updated: | August 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00634322 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
osteosarcoma high dose methotrexate leucovorin |
|
Antimetabolites Vitamin B Complex Immunologic Factors Folate Osteosarcoma Leucovorin Trace Elements Folinic Acid Folic Acid Antagonists Immunosuppressive Agents Vitamin B9 |
Folic Acid Neoplasms, Connective and Soft Tissue Malignant Mesenchymal Tumor Soft Tissue Sarcomas Vitamins Sarcoma Osteogenic Sarcoma Methotrexate Micronutrients Antirheumatic Agents |
|
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leucovorin Reproductive Control Agents Neoplasms, Connective and Soft Tissue Vitamins Therapeutic Uses Abortifacient Agents Methotrexate Micronutrients Dermatologic Agents |
Nucleic Acid Synthesis Inhibitors Vitamin B Complex Neoplasms by Histologic Type Growth Substances Osteosarcoma Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms, Bone Tissue Sarcoma Neoplasms, Connective Tissue Antirheumatic Agents |
