Ignite Creation Date:
2024-05-05 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 9:40 AM
Study NCT ID:
NCT00589381
Status:
COMPLETED
Last Update Posted:
2012-03-08
First Post:
2007-12-20
Brief Title:
Fenretinide Lym-X-Sorb in Treating Patients With Recurrent or Resistant Solid Tumors or Lymphoma
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase I Trial of Fenretinide 4-HPR NSC 374551 Lym-X-Sorb LXS Oral Powder 4-HPRLXS Oral Powder 4-HPR in Adults 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 fenretinide Lym-X-Sorb work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing
PURPOSE This phase I trial is studying the side effects and best dose of fenretinide Lym-X-Sorb in treating patients with recurrent or resistant solid tumors or lymphoma
PURPOSE This phase I trial is studying the side effects and best dose of fenretinide Lym-X-Sorb in treating patients with recurrent or resistant solid tumors or lymphoma
Detailed Description:
OBJECTIVES
Primary
To determine the maximum tolerated dose of fenretinide Lym-X-Sorb oral powder 4-HPRLXS oral powder in patients with recurrent andor resistant solid tumors or lymphomas
To define the toxicities of 4-HPRLXS oral powder in these patients
To determine the plasma pharmacokinetics of 4-HPRLXS oral powder in these patients
Secondary
To determine the level of fenretinide delivered as 4-HPRLXS oral powder in normal peripheral blood mononuclear cells
OUTLINE This is a multicenter study
Patients receive oral fenretinide Lym-X-Sorb oral powder 4-HPRLXS oral powder mixed in food carriers three times daily on days 1-7 Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving stable disease response or better may receive additional courses of treatment at the discretion of the treating physician and principal investigator
Blood samples are collected periodically for pharmacokinetic and pharmacodynamic studies
Primary
To determine the maximum tolerated dose of fenretinide Lym-X-Sorb oral powder 4-HPRLXS oral powder in patients with recurrent andor resistant solid tumors or lymphomas
To define the toxicities of 4-HPRLXS oral powder in these patients
To determine the plasma pharmacokinetics of 4-HPRLXS oral powder in these patients
Secondary
To determine the level of fenretinide delivered as 4-HPRLXS oral powder in normal peripheral blood mononuclear cells
OUTLINE This is a multicenter study
Patients receive oral fenretinide Lym-X-Sorb oral powder 4-HPRLXS oral powder mixed in food carriers three times daily on days 1-7 Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving stable disease response or better may receive additional courses of treatment at the discretion of the treating physician and principal investigator
Blood samples are collected periodically for pharmacokinetic and pharmacodynamic studies
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 |
|---|---|---|---|
| CDR0000580777 | None | None | None |
| 08-C-0030 | None | None | None |
| NCI-P07187 | None | None | None |