Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354185
Status:
TERMINATED
Last Update Posted:
2013-05-16
First Post:
2006-07-19
Brief Title:
PXD101 and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Metastatic or Unresectable Solid Tumors or Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of PXD101 in Combination With 17-AAG in Advanced Malignancies
Status:
TERMINATED
Status Verified Date:
2013-05
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:
This phase I trial is studying the side effects and best dose of giving PDX101 together with 17-AAG in treating patients with metastatic or unresectable solid tumors or lymphoma PDX101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer Drugs used in chemotherapy such as 17-N-allylamino-17-demethoxygeldanamycin 17-AAG work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving PXD101 together with 17-AAG may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the safety and tolerability of PXD101 and 17-AAG administered to patients with refractory solid tumor malignancies
II To determine the maximum tolerated dose MTD and recommended phase II dose of PXD101 and 17-AAG in patients with refractory solid tumor malignancies
SECONDARY OBJECTIVES
I To evaluate the pharmacokinetics of PXD101 and 17-AAG in patients receiving this combination
II To evaluate the antitumor activity of this combination per tumor measurements using the RECIST criteria
TERTIARY OBJECTIVES
I To evaluate the effect of treatment with PXD101 and 17-AAG on the transcriptional upregulation of targeted genes in tumor and surrogate tissue PBMCs by means of RTPCR and incorporation of the chromatin immunoprecipitation assay
II To evaluate the effect of this combination treatment on the post translational modification of histones from tumor and surrogate tissue PBMCs
OUTLINE This is a dose-escalation study
Patients receive 17-N-allylamino-17-demethoxygeldanamycin 17-AAG IV over 2 hours on days 1 4 8 and 11 and PXD101 IV over 30 minutes on days 1-5 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of 17-AAG and PDX101 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 Up to 12 patients are treated at the MTD
Patients undergo blood collection on days 1 and 4 of course 1 for pharmacokinetic studies
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study
I To evaluate the safety and tolerability of PXD101 and 17-AAG administered to patients with refractory solid tumor malignancies
II To determine the maximum tolerated dose MTD and recommended phase II dose of PXD101 and 17-AAG in patients with refractory solid tumor malignancies
SECONDARY OBJECTIVES
I To evaluate the pharmacokinetics of PXD101 and 17-AAG in patients receiving this combination
II To evaluate the antitumor activity of this combination per tumor measurements using the RECIST criteria
TERTIARY OBJECTIVES
I To evaluate the effect of treatment with PXD101 and 17-AAG on the transcriptional upregulation of targeted genes in tumor and surrogate tissue PBMCs by means of RTPCR and incorporation of the chromatin immunoprecipitation assay
II To evaluate the effect of this combination treatment on the post translational modification of histones from tumor and surrogate tissue PBMCs
OUTLINE This is a dose-escalation study
Patients receive 17-N-allylamino-17-demethoxygeldanamycin 17-AAG IV over 2 hours on days 1 4 8 and 11 and PXD101 IV over 30 minutes on days 1-5 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of 17-AAG and PDX101 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 Up to 12 patients are treated at the MTD
Patients undergo blood collection on days 1 and 4 of course 1 for pharmacokinetic studies
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study
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 |
|---|---|---|---|
| U01CA062491 | NIH | None | httpsreporternihgovquickSearchU01CA062491 |
| CO 05906 | None | None | None |
| WCCC-CO-05906 | None | None | None |
| NCI-7277 | None | None | None |