Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00301067
Status:
COMPLETED
Last Update Posted:
2019-06-04
First Post:
2006-03-08
Brief Title:
Phase III Study of High-Dose Calcitriol Plus Temodar for Patients With Metastatic Melanoma
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Phase III Study of High-Dose Calcitriol in Combination With Temozolomide for Patients With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2019-05
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:
RATIONALE Drugs used in chemotherapy such as temozolomide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Calcitriol may help temozolomide kill more tumor cells by making them more sensitive to the drug Calcitriol may also stop the growth of melanoma by blocking blood flow to the tumor
PURPOSE This phase III trial is studying the best dose of calcitriol the side effects of calcitriol when given together with temozolomide and to see how well they work in treating patients with metastatic stage IV melanoma
PURPOSE This phase III trial is studying the best dose of calcitriol the side effects of calcitriol when given together with temozolomide and to see how well they work in treating patients with metastatic stage IV melanoma
Detailed Description:
Phase I Patients receive oral calcitriol on days 1 and 15 and oral temozolomide on days 2-8 and 16-22 Treatment repeats every 28 days for 2 courses in the absence of unacceptable toxicity Responding patients continue therapy for up to 6 courses in the absence of unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of calcitriol until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
Phase II Patients receive temozolomide and calcitriol at the MTD as in phase I
After completion of study treatment patients are followed every 3 months
Cohorts of 3-6 patients receive escalating doses of calcitriol until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
Phase II Patients receive temozolomide and calcitriol at the MTD as in phase I
After completion of study treatment patients are followed every 3 months
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 |
|---|---|---|---|
| SPRI-NU-05M1 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA060553 |
| P30CA060553 | NIH | None | None |
| NU-05M1 | None | None | None |
| NU-0310-093 | None | None | None |