Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003885
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
1999-11-01
Brief Title:
Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Leukemia Chronic Myeloide Leukemia Myelodysplasia Lymphoma or Myeloma
Sponsor:
Our Lady of Mercy Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Arsenic Trioxide in RelapsedRefractory Acute Leukemia and Blast Crisis of Chronic Myeloid Leukemia
Status:
UNKNOWN
Status Verified Date:
2000-06
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent or refractory acute leukemia chronic myeloid leukemia myelodysplasia lymphoma or myeloma
PURPOSE Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent or refractory acute leukemia chronic myeloid leukemia myelodysplasia lymphoma or myeloma
Detailed Description:
OBJECTIVES I Determine the effect of arsenic trioxide on the remission rate in patients with recurrent or refractory acute leukemia blast crisis chronic myeloid leukemia myelodysplasia lymphoma or myeloma II Determine the time to progression and survival in patients treated with this regimen III Determine the toxic effects of this regimen in these patients
OUTLINE Patients are stratified into 1 of 8 categories first relapse no greater than 6 months after complete response vs second relapse or refractory vs prior hematologic disorder vs myeloid blast crisis of chronic myeloid leukemia vs lymphoid leukemia vs lymphoma vs myeloma vs myelodysplasia Patients receive IV arsenic trioxide over 2-3 hours for 5 consecutive days with 2 days of rest Treatment continues in the absence of disease progression until complete response or 90 days is reached Upon achieving complete response treatment is discontinued for 30 days Patients exhibiting complete response receive a second 28 day course of consolidation therapy while in remission starting no sooner than 31 days after the end of induction therapy Patients are followed monthly
PROJECTED ACCRUAL A total of 14-29 patients per lymphoma and myeloma stratum and a total of 31 patients per leukemia stratum will be accrued for this study within 18-24 months
OUTLINE Patients are stratified into 1 of 8 categories first relapse no greater than 6 months after complete response vs second relapse or refractory vs prior hematologic disorder vs myeloid blast crisis of chronic myeloid leukemia vs lymphoid leukemia vs lymphoma vs myeloma vs myelodysplasia Patients receive IV arsenic trioxide over 2-3 hours for 5 consecutive days with 2 days of rest Treatment continues in the absence of disease progression until complete response or 90 days is reached Upon achieving complete response treatment is discontinued for 30 days Patients exhibiting complete response receive a second 28 day course of consolidation therapy while in remission starting no sooner than 31 days after the end of induction therapy Patients are followed monthly
PROJECTED ACCRUAL A total of 14-29 patients per lymphoma and myeloma stratum and a total of 31 patients per leukemia stratum will be accrued for this study within 18-24 months
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 |
|---|---|---|---|
| NCI-V99-1545 | None | None | None |
| OLMMC-9808 | None | None | None |
| OLMMC-FDR001699 | None | None | None |