Clinical Study of Plitidepsin (Aplidin®) in Combination With Cytarabine in Patients With Relapsed/Refractory Leukemia
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|ClinicalTrials.gov Identifier: NCT00780143|
Recruitment Status : Terminated (Poor recruitment)
First Posted : October 27, 2008
Last Update Posted : October 28, 2014
|Condition or disease||Intervention/treatment||Phase|
|Relapsed/Refractory Leukemia||Drug: Plitidepsin plus Cytarabine||Phase 1 Phase 2|
This is a Phase I/II study to determine:
- the safety, tolerability and to identify the MTD and DLT of Plitidepsin in combination with a fixed dose of Cytarabine in patients with relapsed/refractory leukemia and to determine the response rate of the combination of Plitidepsin with Cytarabine in patients with relapsed/refractory AML treated at the MTD.
- the pharmacokinetic parameters of Plitidepsin in combination with Cytarabine.
- whether Plitidepsin in combination with Cytarabine exerts antiangiogenic effects as measured by reduction in microvessel density and VEGFR-1 expression in bone marrow biopsies of patients with relapsed/refractory leukemia.
- whether measurement of free serum VEGF levels, soluble circulating VEGF Receptor and Peripheral Progenitor Endothelial cells provide an early marker of response to Plitidepsin.
- the effects of Plitidepsin and Cytarabine on cytidine deaminase activity and correlate results with Cytarabine drug resistance.
- changes in leukemic gene expression as a result of Plitidepsin and Cytarabine administration.
- tumor response duration.
- progression free survival and overall survival.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Plitidepsin (Aplidin®) in Combination With Cytarabine in Patients With Relapsed/Refractory Leukemia|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
Experimental: Arm 1
Plitidepsin in combination with Cytarabine
Drug: Plitidepsin plus Cytarabine
Plitidepsin 0.54 mg /m2 (initial dose)daily x 5 one hour infusion every 3 weeks plus Cytarabine 1 g/m2 daily for 5 days.
- To determine safety,tolerability & to identify:MTD & DLT of Plitidepsin + Cytarabine in patients with relapsed/refractory leukemia. To determine response rate of the combination Plitidepsin + Cytarabine in relapsed/refractory AML patients treated at MTD [ Time Frame: Along the study ]
- To determine: pharmacokinetic parameters, antiangiogenic effects, measurement of VEGF, effects on cytidine deaminase activity, changes in leukemic gene expression, tumor response duration, progression free survival and overall survival. [ Time Frame: Along the study ]
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): NCT00780143
|United States, New Jersey|
|The Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08901|
|Principal Investigator:||Mecide Gharibo, M.D.||Rutgers Cancer Institute of New Jersey|