Cyclosporine and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT00002688|
Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : July 29, 2004
Last Update Posted : December 19, 2013
RATIONALE: Some cancers become resistant to chemotherapy drugs. Combining cyclosporine with chemotherapy may prevent resistance to the drugs and allow the cancer cells to be killed.
PURPOSE: Randomized phase II trial to study the effectiveness of adding cyclosporine to combination chemotherapy in treating patients with relapsed or refractory acute myeloid leukemia.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: cyclosporine Drug: etoposide Drug: mitoxantrone hydrochloride||Phase 2|
OBJECTIVES: I. Evaluate whether the addition of cyclosporine (CYSP) to mitoxantrone (DHAD) and etoposide (VP-16) increases the response rate and duration of response in adults with refractory or relapsed acute myelogenous leukemia (AML). II. Correlate response to this treatment with the presence of P-glycoprotein (P-gp) multidrug resistance (MDR) and the degree of in vitro modulation of leukemic blasts, including CD34+ blasts. III. Correlate response with the presence of other resistance mechanisms, such as atypical MDR and non-P-gp phenotype. IV. Evaluate the toxicity of this treatment in AML patients. V. Study the effect of CYSP on DHAD and VP-16 pharmacokinetics and metabolism and, potentially, on intracellular drug accumulation.
OUTLINE: Randomized study. The following acronyms are used: CYSP Cyclosporine, NSC-290193 DHAD Mitoxantrone, NSC-301739 VP-16 Etoposide, NSC-141540 Arm I: 2-Drug Combination Chemotherapy. DHAD; VP-16. Arm II: 2-Drug Combination Chemotherapy with Drug Resistance Inhibition. DHAD; VP-16; with CYSP.
PROJECTED ACCRUAL: At least 25 patients/arm will be entered over approximately 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Official Title:||AML-MVPCYA: ADDITION OF CYCLOSPORIN A TO THE COMBINATION OF MITOXANTRONE AND ETOPOSIDE (VP 16,213) TO OVERCOME RESISTANCE TO CHEMOTHERAPY IN REFRACTORY AML: A RANDOMIZED PHASE II STUDY|
|Study Start Date :||February 1995|
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): NCT00002688
|Cliniques Universitaires Saint-Luc|
|Brussels (Bruxelles), Belgium, 1200|
|Leuven, Belgium, B-3000|
|'s-Gravenhage (Den Haag, The Hague), Netherlands, 2545 CH|
|Academisch Ziekenhuis der Vrije Universiteit|
|Amsterdam, Netherlands, 1007 MB|
|Academisch Medisch Centrum|
|Amsterdam, Netherlands, 1105 AZ|
|Academisch Ziekenhuis Groningen|
|Groningen, Netherlands, 9713 EZ|
|Academisch Ziekenhuis Maastricht|
|Maastricht, Netherlands, 6202 AZ|
|University Hospital - Rotterdam Dijkzigt|
|Rotterdam, Netherlands, 3000 CA|
|Academisch Ziekenhuis Utrecht|
|Utrecht, Netherlands, 3508 GA|
|Basel, Switzerland, CH-4031|
|Bern, Switzerland, CH-3010|
|Zurich, Switzerland, CH-8091|
|Study Chair:||Simon Daenen, MD, PhD||University Medical Center Groningen|