Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217412
Status:
COMPLETED
Last Update Posted:
2014-06-17
First Post:
2005-09-20
Brief Title:
Vorinostat With or Without Isotretinoin in Treating Young Patients With Recurrent or Refractory Solid Tumors Lymphoma or Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 1 Study of SAHA NSC 701852 in Pediatric Patients With Recurrent or Refractory Solid Tumors Including Lymphomas and Leukemia Followed by a Phase I Study of SAHA in Combination With 13-Cis-Retinoic Acid for Patients With Selected RecurrentRefractory Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-04
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 vorinostat when given together with isotretinoin in treating young patients with recurrent or refractory solid tumors lymphoma or leukemia Drugs used in chemotherapy such as vorinostat work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Vorinostat may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer Isotretinoin may cause cancer cells to look more like normal cells and to grow and spread more slowly Giving vorinostat together with isotretinoin may be an effective treatment for cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose MTD of vorinostat SAHA in young patients with recurrent or refractory solid tumors or lymphomas
II Determine the MTD of SAHA administered in combination with isotretinoin in young patients with recurrent or refractory neuroblastoma medulloblastomaCNS primitive neuroectodermal tumor or atypical teratoid rhabdoid tumor
III Determine the tolerability of the solid tumor MTD of SAHA in young patients with recurrent or refractory leukemia
IV Determine the toxic effects of SAHA administered with or without isotretinoin in these patients
V Determine the pharmacokinetics of this drug in these patients
SECONDARY OBJECTIVES
I Determine preliminarily the antitumor activity of SAHA administered with or without isotretinoin in these patients
II Correlate the pharmacokinetics of this drug with genetic polymorphisms eg UGT1A1 in these patients
OUTLINE This is a multicenter dose-escalation study of vorinostat SAHA
Group 1 solid tumor or lymphoma patients Patients receive oral SAHA once daily on days 1-28 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicityCohorts of 3-6 patients receive escalating doses of SAHA 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 An additional 6 patients may be treated at the MTD
Group 2 leukemia patients Patients receive SAHA as in group 1 at the MTD
Group 3 select solid tumor patients Patients receive oral isotretinoin twice daily on days 1-14 Patients also receive SAHA once daily on days 1-28 OR once on days 1 3 5 8 10 12 15 17 19 22 24 and 26 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicityThe MTD of SAHA is determined as in group 1 An additional 6 patients may be treated at the MTD
After completion of study treatment patients are followed periodically
I Determine the maximum tolerated dose MTD of vorinostat SAHA in young patients with recurrent or refractory solid tumors or lymphomas
II Determine the MTD of SAHA administered in combination with isotretinoin in young patients with recurrent or refractory neuroblastoma medulloblastomaCNS primitive neuroectodermal tumor or atypical teratoid rhabdoid tumor
III Determine the tolerability of the solid tumor MTD of SAHA in young patients with recurrent or refractory leukemia
IV Determine the toxic effects of SAHA administered with or without isotretinoin in these patients
V Determine the pharmacokinetics of this drug in these patients
SECONDARY OBJECTIVES
I Determine preliminarily the antitumor activity of SAHA administered with or without isotretinoin in these patients
II Correlate the pharmacokinetics of this drug with genetic polymorphisms eg UGT1A1 in these patients
OUTLINE This is a multicenter dose-escalation study of vorinostat SAHA
Group 1 solid tumor or lymphoma patients Patients receive oral SAHA once daily on days 1-28 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicityCohorts of 3-6 patients receive escalating doses of SAHA 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 An additional 6 patients may be treated at the MTD
Group 2 leukemia patients Patients receive SAHA as in group 1 at the MTD
Group 3 select solid tumor patients Patients receive oral isotretinoin twice daily on days 1-14 Patients also receive SAHA once daily on days 1-28 OR once on days 1 3 5 8 10 12 15 17 19 22 24 and 26 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicityThe MTD of SAHA is determined as in group 1 An additional 6 patients may be treated at the MTD
After completion of study treatment patients are followed periodically
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 |
|---|---|---|---|
| ADVL0416 | OTHER | CTEP | None |
| NCI-2012-01821 | REGISTRY | None | None |
| CDR0000440999 | None | None | None |
| COG-ADVL0416 | None | None | None |
| NCI-06-C-0254 | None | None | None |
| ADVL0416 | OTHER | None | None |