Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003802
Status:
COMPLETED
Last Update Posted:
2012-12-17
First Post:
1999-11-01
Brief Title:
Pyrazoloacridine in Treating Patients With Metastatic Skin or Eye Melanoma
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Phase II Trial of Pyrazoloacridine NSC 366140 IND 36325 in Metastatic Cutaneous and Ocular Melanoma
Status:
COMPLETED
Status Verified Date:
2012-12
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 use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of pyrazoloacridine in treating patients who have metastatic skin or eye melanoma
PURPOSE Phase II trial to study the effectiveness of pyrazoloacridine in treating patients who have metastatic skin or eye melanoma
Detailed Description:
OBJECTIVES
Assess the antitumor activity of pyrazoloacridine PZA in chemotherapy naive patients with metastatic cutaneous or ocular melanoma
Determine the toxic effects of PZA in this patient population
Determine the pharmacokinetic profile of PZA in these patients
OUTLINE Patients are stratified into cutaneous or ocular melanoma treatment groups
Patients receive pyrazoloacridine IV over 3 hours on day 1 Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL Approximately 28-70 patients will be accrued for this study
Assess the antitumor activity of pyrazoloacridine PZA in chemotherapy naive patients with metastatic cutaneous or ocular melanoma
Determine the toxic effects of PZA in this patient population
Determine the pharmacokinetic profile of PZA in these patients
OUTLINE Patients are stratified into cutaneous or ocular melanoma treatment groups
Patients receive pyrazoloacridine IV over 3 hours on day 1 Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL Approximately 28-70 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-T96-0116 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |
| U01CA063437 | NIH | None | None |
| P30CA006973 | NIH | None | None |
| JHOC-98111005 | None | None | None |
| JHOC-JH9875 | None | None | None |
| JHOC-T96-0116 | None | None | None |