Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088868
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
2004-08-04
Brief Title:
17-Dimethylaminoethylamino-17-demethoxygeldanamycin 17-DMAG in Treating Patients With an Advanced Solid Tumor or Lymphoma
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Study Of 17-Dimethylaminoethylamino-17-demethoxygeldanamycin 17DMAG With Evaluation Of Hsp90 Client Proteins In Subjects With Solid Tumors And Lymphomas
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as 17-dimethylaminoethylamino-17-demethoxygeldanamycin 17-DMAG work in different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE This phase I trial is studying the side effects and best dose of 17-DMAG in treating patients with an advanced solid tumor or lymphoma
PURPOSE This phase I trial is studying the side effects and best dose of 17-DMAG in treating patients with an advanced solid tumor or lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin 17-DMAG in patients with an advanced malignant solid tumor or lymphoma
Determine the dose-limiting toxic effects and toxicity profile of this drug in these patients
Secondary
Compare the effects of this drug on heat shock protein 90 Hsp90 client proteins when assayed in peripheral blood mononuclear cells PBMC vs tumor tissue from patients treated with this drug
Correlate disturbances in key signaling pathways with administration of this drug in these patients
Determine the dose that alters key proteins in the majority of patients treated with this drug
Correlate serum proteomic patterns with target interactions or DMAG clinical effects in patients treated with this drug
Determine the pharmacokinetics of this drug in these patients
OUTLINE This is a single-center dose-escalation study
Patients receive 17-dimethylaminoethylamino-17-demethoxygeldanamycin 17-DMAG IV over 1-2 hour on days 1 and 4 or days 2 and 5 weekly for 4 weeks Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 patients receive escalating doses of 17-DMAG until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of up to 6 patients experience dose-limiting toxicity Once the MTD is determined 10 additional patients are treated at the MTD
PROJECTED ACCRUAL Approximately 40 patients will be accrued for this study within 2 years
Primary
Determine the maximum tolerated dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin 17-DMAG in patients with an advanced malignant solid tumor or lymphoma
Determine the dose-limiting toxic effects and toxicity profile of this drug in these patients
Secondary
Compare the effects of this drug on heat shock protein 90 Hsp90 client proteins when assayed in peripheral blood mononuclear cells PBMC vs tumor tissue from patients treated with this drug
Correlate disturbances in key signaling pathways with administration of this drug in these patients
Determine the dose that alters key proteins in the majority of patients treated with this drug
Correlate serum proteomic patterns with target interactions or DMAG clinical effects in patients treated with this drug
Determine the pharmacokinetics of this drug in these patients
OUTLINE This is a single-center dose-escalation study
Patients receive 17-dimethylaminoethylamino-17-demethoxygeldanamycin 17-DMAG IV over 1-2 hour on days 1 and 4 or days 2 and 5 weekly for 4 weeks Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 patients receive escalating doses of 17-DMAG until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of up to 6 patients experience dose-limiting toxicity Once the MTD is determined 10 additional patients are treated at the MTD
PROJECTED ACCRUAL Approximately 40 patients will be accrued for this study within 2 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 |
|---|---|---|---|
| CDR0000377488 | None | None | None |
| 04-C-0218 | None | None | None |
| NCI-6544 | None | None | None |