A Pharmacokinetic Study of Melphalan in Children
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|ClinicalTrials.gov Identifier: NCT02390544|
Recruitment Status : Recruiting
First Posted : March 17, 2015
Last Update Posted : November 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hematopoietic Stem Cell Transplantation||Drug: Melphalan||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Melphalan Pharmacokinetics in Children Undergoing Hematopoietic Stem Cell Transplantation: A Pilot Study|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Melphalan in Patients Receiving HSCT
The investigators will recruit approximately 30 patients who are scheduled to undergo allogeneic transplant with reduced intensity conditioning that includes melphalan. Approximately 10 patients who will receive melphalan as part of their conditioning regimen for an autologous transplant will also be recruited.
A test dose of melphalan will be administered prior to the start of the HSCT preparative regimen. The test dose will equal 10% of the standard dose. Blood samples will be drawn for pharmacokinetic measurement prior to and after the administration of the test dose and again around the full standard dose of melphalan. Urine samples will also be collected around the test dose and full standard dose of melphalan to measure markers of kidney injury.
Melphalan is a bifunctional alkylating agent that inhibits DNA and RNA synthesis, cross-links strands of DNA and acts on both resting and rapidly dividing cells including tumor cells. It is administered intravenously.
Other Name: Alkeran
- To characterize the pharmacokinetics of melphalan in children undergoing HSCT [ Time Frame: Prior to the melphalan infusion, and then approximately 5 min, 15 min, 30 min, 45 min, 60 min, 2, 2.5, 4, and 6 hours after the end of the melphalan infusion. ]Blood samples will be collected at the above time points around the test dose of melphalan and again around the standard full dose of melphalan. AUC will be used to characterize the pharmacokinetics of melphalan.
- Perform measurement of acute kidney injury marker, KIM-1 [ Time Frame: Prior to the melphalan infusion and approximately 8 hours and 24 hours following the end of melphalan infusion. ]Urine samples will be collected at the above time points around the test dose of melphalan and again around the standard full dose of melphalan for measurement of KIM-1.
- Perform measurement of acute kidney injury marker, NGAL [ Time Frame: Prior to the melphalan infusion and approximately 8 hours and 24 hours following the end of melphalan infusion. ]Urine samples will be collected at the above time points around the test dose of melphalan and again around the standard full dose of melphalan for measurement of NGAL.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02390544
|Contact: Sara K Loveless, BSN, RNfirstname.lastname@example.org|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Sharat Chandra, MD||Children's Hospital Medical Center, Cincinnati|
|Principal Investigator:||Parinda Mehta, MD||Children's Hospital Medical Center, Cincinnati|