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

NCT ID: NCT00002688

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-02-28

Brief Summary

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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

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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.

Conditions

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Leukemia

Keywords

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recurrent adult acute myeloid leukemia

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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cyclosporine

Intervention Type DRUG

etoposide

Intervention Type DRUG

mitoxantrone hydrochloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS: Acute myelogenous leukemia (AML) in the following categories: Refractory to initial standard therapy consisting of idarubicin/cytarabine and amsacrin/cytarabine (on protocol HOVON 29) First or subsequent relapse following complete response to standard chemotherapy (on protocols HOVON 4/4A or 11 or any other protocol) At least 6 months between mitoxantrone/etoposide and relapse No myelodysplasia

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Hematopoietic: Not applicable Hepatic: Bilirubin no greater than 2 x normal Alkaline phosphatase no greater than 2 x normal Renal: Creatinine no greater than 1.7 mg/dl (150 micromoles/liter) OR Creatinine clearance at least 60 ml/min Cardiovascular: No uncontrolled hypertension No other severe cardiac disease Pulmonary: No severe pulmonary disease Other: No known intolerance to any study drug No uncontrolled severe infection Not HIV seropositive No severe neurologic or metabolic disease No concomitant malignancy except: Nonmelanomatous skin cancer In situ cervical carcinoma No pregnant women

PRIOR CONCURRENT THERAPY: See Disease Characteristics
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Principal Investigators

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Simon Daenen, MD, PhD

Role: STUDY_CHAIR

University Medical Center Groningen

Locations

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Cliniques Universitaires Saint-Luc

Brussels (Bruxelles), , Belgium

Site Status

U.Z. Gasthuisberg

Leuven, , Belgium

Site Status

Leyenburg Ziekenhuis

's-Gravenhage (Den Haag, the Hague), , Netherlands

Site Status

Academisch Ziekenhuis der Vrije Universiteit

Amsterdam, , Netherlands

Site Status

Academisch Medisch Centrum

Amsterdam, , Netherlands

Site Status

Academisch Ziekenhuis Groningen

Groningen, , Netherlands

Site Status

Academisch Ziekenhuis Maastricht

Maastricht, , Netherlands

Site Status

University Hospital - Rotterdam Dijkzigt

Rotterdam, , Netherlands

Site Status

Academisch Ziekenhuis Utrecht

Utrecht, , Netherlands

Site Status

University Hospital

Basel, , Switzerland

Site Status

Inselspital, Bern

Bern, , Switzerland

Site Status

Universitaetsspital

Zurich, , Switzerland

Site Status

Countries

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Belgium Netherlands Switzerland

Other Identifiers

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DUT-KWF-CKVO-9412

Identifier Type: -

Identifier Source: secondary_id

EU-95003

Identifier Type: -

Identifier Source: secondary_id

CDR0000064413

Identifier Type: -

Identifier Source: org_study_id