Cyclosporine and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Recruitment status was Active, not recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: cyclosporine Drug: etoposide Drug: mitoxantrone hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| 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 |
| Estimated Enrollment: | 25 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Belgium | |
| Cliniques Universitaires Saint-Luc | |
| Brussels (Bruxelles), Belgium, 1200 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Netherlands | |
| Leyenburg Ziekenhuis | |
| 's-Gravenhage (Den Haag, The Hague), Netherlands, 2545 CH | |
| Academisch Medisch Centrum | |
| Amsterdam, Netherlands, 1105 AZ | |
| Academisch Ziekenhuis der Vrije Universiteit | |
| Amsterdam, Netherlands, 1007 MB | |
| 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 | |
| Switzerland | |
| University Hospital | |
| Basel, Switzerland, CH-4031 | |
| Inselspital, Bern | |
| Bern, Switzerland, CH-3010 | |
| Universitaetsspital | |
| Zurich, Switzerland, CH-8091 | |
| Study Chair: | Simon Daenen, MD, PhD | University Medical Centre Groningen |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002688 History of Changes |
| Other Study ID Numbers: | CDR0000064413, DUT-KWF-CKVO-9412, EU-95003 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent adult acute myeloid leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Cyclosporins Cyclosporine Etoposide Etoposide phosphate Mitoxantrone Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents Antineoplastic Agents, Phytogenic Antineoplastic Agents Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013