Cyclosporine and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Phase 2

• Conditions: Leukemia

• Registration Number: NCT00002688
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 1995-02
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-07-28
• Study First Posted: 2004-07-29
• Status Verified: 2007-05
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (12)

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels (Bruxelles), Belgium

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

Leyenburg Ziekenhuis; 🇳🇱 's-Gravenhage (Den Haag, The Hague), Netherlands

Academisch Ziekenhuis der Vrije Universiteit; 🇳🇱 Amsterdam, Netherlands

Academisch Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Academisch Ziekenhuis Groningen; 🇳🇱 Groningen, Netherlands

Academisch Ziekenhuis Maastricht; 🇳🇱 Maastricht, Netherlands

University Hospital - Rotterdam Dijkzigt; 🇳🇱 Rotterdam, Netherlands

Academisch Ziekenhuis Utrecht; 🇳🇱 Utrecht, Netherlands

University Hospital; 🇨🇭 Basel, Switzerland

Scroll for more (2 remaining)