Clinical trials: Methotrexate Toxicity
Cancer
Individualized High Dose Methotrexate to Treat Cancer in Children Who Have a Significant Risk for Side Effects to Methotrexate
Pediatric cancer patients are being asked to take part in this study who have a cancer that is treated with high doses of the drug methotrexate (MTX).
- Trial name
- NCT02076997
- Testing
- Methotrexate
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Baylor College of Medicine
Osteosarcoma, Leukemia
Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze
The purpose of this study is to investigate whether the administration of Voraxaze reduces exposure to leucovorin and its active metabolite to below the level achieved in patients who have not received Voraxaze.
- Conditions
- Osteosarcoma, Leukemia, Lymphoma
- Trial name
- LVPK (NCT00634504)
- Testing
- glucarpidase, high-dose methotrexate, leucovorin, high-dose methotrexate, leucovorin
- Where
- 25 sites in United States
- Volunteers
- 20 people
- Sponsor
- BTG International Inc.
Pediatric NHL
A Retrospective Cohort Study: The Influence of MTHFR C677T and A1298C on the High-dose Methotrexate-Related Toxicities in Pediatric Patients With Non-Hodgkin Lymphoma
We hypothesized that polymorphism MTHFR C677T and A1298C should be associated with HD-MTX-related toxicities in children with NHL. Therefore, we aimed to retrospectively explore their relationships in this analysis.
- Trial name
- NCT04283955
- Testing
- High-dose MTX based chemotherapy
- Where
- China
- Volunteers
- 93 people
- Sponsor
- Sun Yat-sen University
Osteosarcoma, Survival
Comparison of MAPI+Camrelizumab Versus API+Apatinib Versus MAPI in Patients With a Poor Response to Preoperative Chemotherapy for Newly Diagnosed High-grade Osteosarcoma
Treatment strategies for high-grade osteosarcoma with multidrug chemotherapy and resection result in 3-year event-free survival of 60-70%.
- Conditions
- Osteosarcoma, Survival, Chemotherapy Effect, Toxicity, Drug
- Trial name
- MAPAC (NCT04351308)
- Testing
- MAPI chemotherapy, Apatinib Mesylate, Camrelizumab
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Peking University People's Hospital
Osteosarcoma
Investigation of [6R] 5,10-methylenetetrahydrofolate (Arfolitixorin) as Rescue Therapy for Osteosarcoma Patients Treated With HDMTX.
An open-label, multicenter, phase I/II clinical trial to identify the [6R] 5,10-methylenetetrahydrofolate (arfolitixorin) dose with most favorable safety prospect and confirmed ability to mitigate high-dose methotrexate induced…
- Trial name
- NCT01987102
- Testing
- Calcium Folinate, [6R] 5,10-methylenetetrahydrofolate (arfolitixorin)
- Where
- 5 sites in Czechia, Hungary and 2 more
- Volunteers
- 18 people
- Sponsor
- Isofol Medical AB
Leukemia, Renal Toxicity
Kidney Dysfunction in Children and Young Adults Who Have Received Methotrexate for Acute Lymphoblastic Leukemia
RATIONALE: Gathering information about how often kidney dysfunction occurs in children and young adults receiving methotrexate for acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best…
- Trial name
- NCT00993135
- Testing
- methotrexate, medical chart review, assessment of therapy complications
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Vanderbilt University Medical Center
Neurotoxicity, Unspecified Adult Solid Tumor, Protocol Specific
Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal Methotrexate
RATIONALE: Chemoprotective drugs such as carboxypeptidase-G2 may protect normal cells from the toxic effects of chemotherapy. PURPOSE: Clinical trial to study the effectiveness of carboxypeptidase-G2 in treating nervous system…
- Conditions
- Neurotoxicity, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
- Trial name
- NCT00018967
- Testing
- glucarpidase
- Where
- 103 sites in United States, Australia and 2 more
- Volunteers
- 10 people
- Sponsor
- National Cancer Institute (NCI)
Vasculitis, Wegener's Granulomatosis
Cyclophosphamide and Prednisone Followed by Methotrexate To Treat Vasculitides
This study will evaluate the safety and effectiveness of a staged approach to therapy for Wegener's granulomatosis and other systemic vasculitides using prednisone plus cyclophosphamide followed by methotrexate.
- Trial name
- NCT00001473
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Acute Kidney Injury, Drug Toxicity
Retrospective Registry Study of Patients With Cancer Treated With High-dose Methotrexate
This retrospective observational study will evaluate high-dose methotrexate patterns of use, supportive care measures used during high-dose methotrexate chemotherapy, along with the incidence of delayed elimination of…
- Trial name
- NCT05899751
- Testing
- High-dose methotrexate, Glucarpidase
- Where
- 5 sites in France, Italy and 1 more
- Volunteers
- 1,000 people
- Sponsor
- Protherics Medicines Development Limited
Methotrexate Toxicity
Evaluation of High Dose Methotrexate Toxicity
This study aims to: 1. Evaluation of high dose methotrexate related toxicities among children admitted to Sohag Oncology Centre. 2. Role of methotrexate blood level in prediction of high dose methotrexate related toxicities. 3.
- Trial name
- NCT06123403
- Testing
- blood methotrexate level and Cystatin C level
- Volunteers
- 100 people
- Sponsor
- Sohag University
Acute Lymphoblastic Leukemia
The Influence of Thiopurine Methyltransferase Activity on Toxicity After High-dose Methotrexate in Childhood Acute Lymphoblastic Leukemia
The purpose of this study is to explore the impact of thiopurine methyltransferase (TPMT) activity on the risk of HDM-related bone marrow- and hepatotoxicity and treatment interruptions during maintenance therapy for children…
- Trial name
- NCT01886651
- Where
- Denmark
- Volunteers
- 411 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Neoplasms
Treatment Protocol of Voraxaze for Patients Experiencing or at Risk of Methotrexate Toxicity
This protocol is for the treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function
- Trial name
- NCT00481559
- Testing
- Voraxaze (glucarpidase)
- Sponsor
- BTG International Inc.
Vasculitis, Wegener's Granulomatosis
Comparison of Treatments to Maintain Disease Remission in Patients With Wegener's Granulomatosis and Related Vasculitis Syndromes
This study will compare the safety and effectiveness of two drugs-methotrexate and mycophenolate mofetil (MPM)-in preventing disease recurrence in patients with Wegener's granulomatosis and related inflammatory blood vessel…
- Trial name
- NCT00004567
- Testing
- Mycophenolate Mofetil
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
ALL
Prediction of Excretion and Toxicity of High Dose Methotrexate in Children and Adolescents With ALL
Each year approximately 2,900 children and adolescents less than 20 years old are diagnosed with acute lymphoblastic leukemia or acute lymphoblastic lymphoma in the United States.
- Trial name
- NCT02133599
- Testing
- IOHEXOL
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Disorder Related to Bone Marrow Transplantation, Leukemia
Fludarabine-IV Busulfan ± Clofarabine and Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
The goal of this clinical research study is to learn if combining busulfan with clofarabine and fludarabine can help control the disease better than the previous standard method (using busulfan and fludarabine alone) in patients…
- Conditions
- Disorder Related to Bone Marrow Transplantation, Leukemia, Transplantation Infection
- Trial name
- NCT01471444
- Testing
- Fludarabine, Clofarabine, Busulfan
- Where
- United States
- Volunteers
- 256 people
- Sponsor
- M.D. Anderson Cancer Center
Mucositis Oral
Evaluation of Prophylactic Photobiomodulation Therapy in Patients With Osteosarcoma
This study aims to evaluate the photobiomodulation therapy (PBMT) for the prevention of oral mucositis in osteosarcoma patients submitted to high doses of methotrexate, through two different protocols.
- Trial name
- PBMT/MTX (NCT06217224)
- Testing
- Preventive photobiomodulation Therapy (PBMT)
- Where
- Brazil
- Volunteers
- 53 people
- Sponsor
- Instituto Nacional de Cancer, Brazil
Kidney Diseases
A Trial of Carboxypeptidase-G2 (CPDG2) and Thymidine for the Management of Patients With Methotrexate Toxicity and Renal Dysfunction
High dose methotrexate with leucovorin rescue has demonstrated activity in numerous malignancies. Although high dose methotrexate is generally well tolerated, unpredictable life-threatening toxicity can occur.
- Trial name
- NCT00001298
- Testing
- carboxypeptidase-G2
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- National Cancer Institute (NCI)