Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002688
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Cyclosporine and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Sponsor:
University Medical Center Groningen
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
AML-MVPCYA ADDITION OF CYCLOSPORIN A TO THE COMBINATION OF MITOXANTRONE AND ETOPOSIDE VP 16213 TO OVERCOME RESISTANCE TO CHEMOTHERAPY IN REFRACTORY AML A RANDOMIZED PHASE II STUDY
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 patientsarm will be entered over approximately 3 years
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 patientsarm will be entered over approximately 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-95003 | None | None | None |
| DUT-KWF-CKVO-9412 | None | None | None |