Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004065
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
1999-12-10
Brief Title:
Chemotherapy in Treating Patients With Refractory Advanced Solid Tumors or Hematologic Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I Trial of 17-N-Allylamino-17-Demethoxy Geldanamycin 17-AAG NSC 330507 Daily X 5 in Patients With Advanced Cancer Therapeutic Protocol
Status:
COMPLETED
Status Verified Date:
2013-06
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 tumor cells from dividing so they stop growing or die
PURPOSE This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating patients with refractory advanced solid tumors or hematologic cancers
PURPOSE This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating patients with refractory advanced solid tumors or hematologic cancers
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG in patients with refractory or advanced solid tumors or hematologic malignancies
Evaluate the effects of this drug on the expression of signaling proteins present on an individual patients cancer at the start of treatment and if possible post treatment
OUTLINE This is a two-phase dose-escalation multicenter study Patients are stratified according to disease chronic myelogenous leukemia CML or Philadelphia chromosome Ph acute lymphoblastic leukemia ALL vs solid tumor
Patients receive 17-N-allylamino-17-demethoxygeldanamycin 17-AAG IV over 60-90 minutes twice weekly Courses repeat every 12 weeks in the absence of disease progression after at least 2 courses for CML or Ph ALL patients or unacceptable toxicity
Accelerated phase Single patients receive escalating dose levels of 17-AAG until one patient experiences a first course grade 3 or greater toxicity or two different patients experience grade 2 toxicity during any course
Standard phase Cohorts of 3-6 patients in each stratum receive escalating doses of 17-AAG until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 51 patients will be accrued for this study
Determine the maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG in patients with refractory or advanced solid tumors or hematologic malignancies
Evaluate the effects of this drug on the expression of signaling proteins present on an individual patients cancer at the start of treatment and if possible post treatment
OUTLINE This is a two-phase dose-escalation multicenter study Patients are stratified according to disease chronic myelogenous leukemia CML or Philadelphia chromosome Ph acute lymphoblastic leukemia ALL vs solid tumor
Patients receive 17-N-allylamino-17-demethoxygeldanamycin 17-AAG IV over 60-90 minutes twice weekly Courses repeat every 12 weeks in the absence of disease progression after at least 2 courses for CML or Ph ALL patients or unacceptable toxicity
Accelerated phase Single patients receive escalating dose levels of 17-AAG until one patient experiences a first course grade 3 or greater toxicity or two different patients experience grade 2 toxicity during any course
Standard phase Cohorts of 3-6 patients in each stratum receive escalating doses of 17-AAG until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 51 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 |
|---|---|---|---|
| UCLA-0206019 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067267 | REGISTRY | None | None |
| NCI-T99-0035 | None | None | None |