Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003268
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
1999-11-01
Brief Title:
Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Cytosine Arabinoside Idarubicin and Amifostine as Induction Therapy for Patients With Newly Diagnosed Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2003-10
Last Known Status:
None
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy
PURPOSE Phase I trial to study the effectiveness of amifostine in treating patients with newly diagnosed acute myeloid leukemia who are receiving idarubicin plus cytarabine
PURPOSE Phase I trial to study the effectiveness of amifostine in treating patients with newly diagnosed acute myeloid leukemia who are receiving idarubicin plus cytarabine
Detailed Description:
OBJECTIVES
Determine whether amifostine provides systemic protection against the nonhematologic side effects of idarubicin IDR during induction therapy of acute myeloid leukemia AML allowing the dose of idarubicin to be escalated
Determine the maximum tolerated dose of idarubicin when amifostine is used as a chemotherapy protectant
Determine the incidence and severity of dose limiting hypotension in patients receiving amifostine and the ability to offset this side effect with vasoconstrictive agents
Determine whether any additional side effects of amifostine are dose limiting in patients with AML treated with IDR and cytarabine ARA-C
Monitor the frequency of alopecia mucositis diarrhea and septicemia involving enteric pathogens in these patients
Determine the requirement for intravenous hyperalimentation in patients receiving amifostine IDR and ARA-C
OUTLINE This is a dose escalation study of idarubicin IDR
Patients receive amifostine IV over 15 minutes followed 15-30 minutes later by chemotherapy Idarubicin IV is administered over 15 minutes on days 1-3 Cytarabine is administered by continuous infusion on days 1-7 Patients may receive 1 additional course of treatment if necessary
Cohorts of 3-6 patients each are treated at each dose level of idarubicin Dose escalation is discontinued when 2 or more patients experience dose limiting toxicity
Patients are followed at 3 months
PROJECTED ACCRUAL A maximum of 36 patients will be accrued for this study
Determine whether amifostine provides systemic protection against the nonhematologic side effects of idarubicin IDR during induction therapy of acute myeloid leukemia AML allowing the dose of idarubicin to be escalated
Determine the maximum tolerated dose of idarubicin when amifostine is used as a chemotherapy protectant
Determine the incidence and severity of dose limiting hypotension in patients receiving amifostine and the ability to offset this side effect with vasoconstrictive agents
Determine whether any additional side effects of amifostine are dose limiting in patients with AML treated with IDR and cytarabine ARA-C
Monitor the frequency of alopecia mucositis diarrhea and septicemia involving enteric pathogens in these patients
Determine the requirement for intravenous hyperalimentation in patients receiving amifostine IDR and ARA-C
OUTLINE This is a dose escalation study of idarubicin IDR
Patients receive amifostine IV over 15 minutes followed 15-30 minutes later by chemotherapy Idarubicin IV is administered over 15 minutes on days 1-3 Cytarabine is administered by continuous infusion on days 1-7 Patients may receive 1 additional course of treatment if necessary
Cohorts of 3-6 patients each are treated at each dose level of idarubicin Dose escalation is discontinued when 2 or more patients experience dose limiting toxicity
Patients are followed at 3 months
PROJECTED ACCRUAL A maximum of 36 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V98-1395 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066164 | REGISTRY | None | None |
| ALZA-97-040-ii | None | None | None |