Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006091
Status:
WITHDRAWN
Last Update Posted:
2018-11-14
First Post:
2000-08-03
Brief Title:
Arsenic Trioxide in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Has Not Responded to Previous Treatment
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Arsenic Trioxide Therapy for Interferon Alpha Refractory or Intolerant Chronic Phase Chronic Myelogenous Leukemia
Status:
WITHDRAWN
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No enrollment
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 chronic phase chronic myelogenous leukemia that has not responded to previous treatment
PURPOSE Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have chronic phase chronic myelogenous leukemia that has not responded to previous treatment
Detailed Description:
OBJECTIVES
I Determine the rate of complete or major cytogenetic response to arsenic trioxide as demonstrated by a decrease in the percentage of Philadelphia chromosome positive or breakpoint cluster region bcr positive cells in the bone marrow in patients with interferon alfa refractory or intolerant chronic phase chronic myelogenous leukemia
II Determine the rate and duration of complete hematological response to this treatment in these patients
III Determine the duration of complete and major cytogenetic response to this treatment in these patients
IV Determine the pattern of clinical adverse experience and improvement in symptomatic parameters with this treatment in these patients
V Determine the time to accelerated disease or blast crisis and overall survival in these patients after receiving this treatment
VI Determine the effects of this treatment on cytokines apoptosis and angiogenesis in these patients
OUTLINE Patients receive arsenic trioxide intravenous IV over 2 hours either daily for 15 consecutive days or 5 days on 2 days off for a total of 15 doses Treatment repeats every 2-5 weeks after the previous course for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity Patients achieving complete remission are followed every month for 3 months every 2 months for 6 months every 3-4 months for 1 year and then every 6 months thereafter All other patients are followed every 3 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 17-53 patients will be accrued for this study within 25 years
I Determine the rate of complete or major cytogenetic response to arsenic trioxide as demonstrated by a decrease in the percentage of Philadelphia chromosome positive or breakpoint cluster region bcr positive cells in the bone marrow in patients with interferon alfa refractory or intolerant chronic phase chronic myelogenous leukemia
II Determine the rate and duration of complete hematological response to this treatment in these patients
III Determine the duration of complete and major cytogenetic response to this treatment in these patients
IV Determine the pattern of clinical adverse experience and improvement in symptomatic parameters with this treatment in these patients
V Determine the time to accelerated disease or blast crisis and overall survival in these patients after receiving this treatment
VI Determine the effects of this treatment on cytokines apoptosis and angiogenesis in these patients
OUTLINE Patients receive arsenic trioxide intravenous IV over 2 hours either daily for 15 consecutive days or 5 days on 2 days off for a total of 15 doses Treatment repeats every 2-5 weeks after the previous course for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity Patients achieving complete remission are followed every month for 3 months every 2 months for 6 months every 3-4 months for 1 year and then every 6 months thereafter All other patients are followed every 3 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 17-53 patients will be accrued for this study within 25 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 |
|---|---|---|---|
| ID00-058 | OTHER | UT MD Anderson Cancer Center | None |
| MDA-DM-00058 | None | None | None |
| NCI-311 | None | None | None |