Cyclosporine and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
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.
Drug: mitoxantrone hydrochloride
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|