Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060125
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2003-05-06
Brief Title:
Tipifarnib in Treating Patients With Metastatic Malignant Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PHASE II TRIAL OF R115777 IN PATIENTS WITH METASTATIC MALIGNANT MELANOMA
Status:
COMPLETED
Status Verified Date:
2013-06
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 II trial is studying how well tipifarnib works in treating patients with metastatic malignant melanoma Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the clinical response rate in patients with metastatic malignant melanoma treated with R115777 tipifarnib
II To evaluate the safety of R115777 in patients with metastatic melanoma
SECONDARY OBJECTIVES
I To assess RhoC expression in tumor samples pre- and post- therapy with R115777
II To evaluate Ftase levels in peripheral blood and tumor samples pre- and post-therapy with R115777
III To assess the effect of R115777 treatment on T lymphocyte cytokine production pre- and post- therapy with R115777
IV Estimate time to treatment failure TTF Time to treatment failure is defined as time to withdrawal for unacceptable toxicity or progressive disease
OUTLINE Patients receive oral tipifarnib twice daily on days 1-21 Treatment repeats every 28 days for at least 2 courses and for a maximum of 2 years in the absence of disease progression or unacceptable toxicity Patients who achieve complete response CR receive 2 additional courses beyond CR
Patients who discontinue therapy due to toxicity or complete response are followed every 3 months for 2 years after study entry Patients who discontinue therapy due to disease progression are followed every 6 months for 2 years after study entry Patients with stable or partially responding disease who complete treatment are followed at 2 years after study entry
I To estimate the clinical response rate in patients with metastatic malignant melanoma treated with R115777 tipifarnib
II To evaluate the safety of R115777 in patients with metastatic melanoma
SECONDARY OBJECTIVES
I To assess RhoC expression in tumor samples pre- and post- therapy with R115777
II To evaluate Ftase levels in peripheral blood and tumor samples pre- and post-therapy with R115777
III To assess the effect of R115777 treatment on T lymphocyte cytokine production pre- and post- therapy with R115777
IV Estimate time to treatment failure TTF Time to treatment failure is defined as time to withdrawal for unacceptable toxicity or progressive disease
OUTLINE Patients receive oral tipifarnib twice daily on days 1-21 Treatment repeats every 28 days for at least 2 courses and for a maximum of 2 years in the absence of disease progression or unacceptable toxicity Patients who achieve complete response CR receive 2 additional courses beyond CR
Patients who discontinue therapy due to toxicity or complete response are followed every 3 months for 2 years after study entry Patients who discontinue therapy due to disease progression are followed every 6 months for 2 years after study entry Patients with stable or partially responding disease who complete treatment are followed at 2 years after study entry
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 |
|---|---|---|---|
| U10CA031946 | NIH | None | httpsreporternihgovquickSearchU10CA031946 |
| CALGB-500104 | None | None | None |
| CDR0000299508 | None | None | None |