Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002946
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
1999-11-01
Brief Title:
Penclomedine in Treating Patients With Solid Tumors or Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of Oral Penclomedine
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase I trial to study the effectiveness of penclomedine in treating patients with malignant solid tumors or lymphomas Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose MTD and Phase II dose of oral penclomedine in patients with malignancies
II Determine the toxic effects of oral penclomedine in these patients III Determine the pharmacokinetics of oral penclomedine in these patients IV Determine the bioavailability of oral penclomedine in these patients
OUTLINE
Patients enrolled on the bioavailability portion of this study receive one dose of IV penclomedine over 1 hour followed by 2 weeks of rest At the end of two weeks they receive oral penclomedine for 5 days every 28 days The starting dose is determined by a single primary patient who has been administered oral penclomedine and observed for dose limiting toxicity DLT Bioavailability portion completed as of 398 Those not on the bioavailability portion of study start on a standard design dose escalating schedule in which patients enroll in cohorts of 3 Patients are administered oral penclomedine daily for 5 days This treatment repeats every 4 weeks The MTD is defined as the dose immediately below that at which 2 patients experience DLT Treatment repeats for 6 courses or until severe toxicity or tumor progression is observed
I Determine the maximum tolerated dose MTD and Phase II dose of oral penclomedine in patients with malignancies
II Determine the toxic effects of oral penclomedine in these patients III Determine the pharmacokinetics of oral penclomedine in these patients IV Determine the bioavailability of oral penclomedine in these patients
OUTLINE
Patients enrolled on the bioavailability portion of this study receive one dose of IV penclomedine over 1 hour followed by 2 weeks of rest At the end of two weeks they receive oral penclomedine for 5 days every 28 days The starting dose is determined by a single primary patient who has been administered oral penclomedine and observed for dose limiting toxicity DLT Bioavailability portion completed as of 398 Those not on the bioavailability portion of study start on a standard design dose escalating schedule in which patients enroll in cohorts of 3 Patients are administered oral penclomedine daily for 5 days This treatment repeats every 4 weeks The MTD is defined as the dose immediately below that at which 2 patients experience DLT Treatment repeats for 6 courses or until severe toxicity or tumor progression is observed
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 |
|---|---|---|---|
| CDR0000065413 | REGISTRY | PDQ Physician Data Query | None |
| WCCC-CO-9693 | None | None | None |
| NCI-T96-0067 | None | None | None |