Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-28 @ 9:05 AM
Study NCT ID:
NCT00088868
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
2004-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
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:
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?: