Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003003
Status:
COMPLETED
Last Update Posted:
2018-03-19
First Post:
1999-11-01
Brief Title:
Mitomycin and Mitoxantrone in Treating Patients With Acute Myelogenous Leukemia
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
A Pilot Clinical Trial of Mitomycin C Modulation of Multidrug Resistance Proteins and a Phase I Evaluation of Mitomycin C and Mitoxantrone in Patients With Acute Myelogenous Leukemia
Status:
COMPLETED
Status Verified Date:
2000-06
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 cancer cells from dividing so they stop growing or die Some cancers become resistant to chemotherapy drugs Combining mitomycin with a chemotherapy drug may reduce resistance to the drug and allow the cancer cells to be killed
PURPOSE Phase I trial to study the effectiveness of mitomycin and mitoxantrone in treating patients with acute myelogenous leukemia and to determine whether mitomycin can reduce the cancers resistance to chemotherapy
PURPOSE Phase I trial to study the effectiveness of mitomycin and mitoxantrone in treating patients with acute myelogenous leukemia and to determine whether mitomycin can reduce the cancers resistance to chemotherapy
Detailed Description:
OBJECTIVES I Determine whether a single mitomycin C treatment will suppress expression of one or more proteins associated with the multidrug resistance phenotype in leukemia cells of patients with refractory acute myelogenous leukemia II Determine the maximum tolerated dose of a combination of mitomycin C followed 72 hours later by a single dose of mitoxantrone in patients with acute myelogenous leukemia with GM-CSF support III Determine the toxicity profile and pharmokinetics for these combinations of mitomycin C and mitoxantrone IV Determine the ability of this regimen to induce complete response in patients with primary resistant or refractory acute myelogenous leukemia
OUTLINE Patients receive mitomycin C by IV bolus on day 1 of treatment Patients receive mitoxantrone beginning on day 4 One patient each is entered at the first and second dose levels Dose escalation of mitoxantrone continues in the absence of toxicity If the patient experiences toxicity at level 1 or 2 then 2 additional patients are entered at that tier Three patients are entered at all subsequent tiers At these tiers if no toxicity is observed escalation continues If 1 of the 3 patients experiences toxicity an additional 3 patients are enrolled at the same dose If none of these additional patients experiences toxicity escalation continues however if 1 patient has toxicity the trial is stopped If 2 or more have toxicities the dose is de-escalated If 2 or more of the original 3 patients have toxicities the dose is de-escalated On day 15 patients are treated with sargramostim GM-CSF intravenously over 4 hours if the bone marrow is free of residual leukemia GM-CSF treatment continues until the ANC is greater than 1500mm3 for 3 consecutive days
PROJECTED ACCRUAL For the pilot study of mitomycin C modulation of multidrug resistance proteins 12 patients will be accrued For the phase I study of mitomycin C and mitoxantrone at least 17 patients will be entered
OUTLINE Patients receive mitomycin C by IV bolus on day 1 of treatment Patients receive mitoxantrone beginning on day 4 One patient each is entered at the first and second dose levels Dose escalation of mitoxantrone continues in the absence of toxicity If the patient experiences toxicity at level 1 or 2 then 2 additional patients are entered at that tier Three patients are entered at all subsequent tiers At these tiers if no toxicity is observed escalation continues If 1 of the 3 patients experiences toxicity an additional 3 patients are enrolled at the same dose If none of these additional patients experiences toxicity escalation continues however if 1 patient has toxicity the trial is stopped If 2 or more have toxicities the dose is de-escalated If 2 or more of the original 3 patients have toxicities the dose is de-escalated On day 15 patients are treated with sargramostim GM-CSF intravenously over 4 hours if the bone marrow is free of residual leukemia GM-CSF treatment continues until the ANC is greater than 1500mm3 for 3 consecutive days
PROJECTED ACCRUAL For the pilot study of mitomycin C modulation of multidrug resistance proteins 12 patients will be accrued For the phase I study of mitomycin C and mitoxantrone at least 17 patients will be entered
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-V97-1260 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA023108 |
| P30CA023108 | NIH | None | None |
| DMS-9614 | None | None | None |