Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104897
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2005-03-03
Brief Title:
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Metastatic Malignant Melanoma
Sponsor:
Cancer Research UK
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial to Assess the Activity of 17-allylamino 17-demethoxygeldanamycin 17-AAG in Patients With Metastatic M1 M1b M1c Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2008-03
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 17-N-allylamino-17-demethoxygeldanamycin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
PURPOSE This phase II trial is studying how well 17-N-allylamino-17-demethoxygeldanamycin works in treating patients with metastatic malignant melanoma
PURPOSE This phase II trial is studying how well 17-N-allylamino-17-demethoxygeldanamycin works in treating patients with metastatic malignant melanoma
Detailed Description:
OBJECTIVES
Primary
Determine the antitumor activity of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG in patients with metastatic malignant melanoma
Determine the progression-free rate in patients treated with this drug
Secondary
Determine the toxicity profile of this drug in these patients
Determine the duration of response in patients treated with this drug
Determine the survival of patients treated with this drug
OUTLINE This is a nonrandomized open-label multicenter study
Patients receive 17-N-allylamino-17-demethoxygeldanamycin 17-AAG IV over 1 hour on days 1 8 15 and 22 Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity After 3 courses of treatment disease response is assessed Patients with stable or responding disease receive additional courses of treatment
After completion of study treatment patients are followed at 28 days and then every 3 months thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 15-25 patients will be accrued for this study within 12-18 months
Primary
Determine the antitumor activity of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG in patients with metastatic malignant melanoma
Determine the progression-free rate in patients treated with this drug
Secondary
Determine the toxicity profile of this drug in these patients
Determine the duration of response in patients treated with this drug
Determine the survival of patients treated with this drug
OUTLINE This is a nonrandomized open-label multicenter study
Patients receive 17-N-allylamino-17-demethoxygeldanamycin 17-AAG IV over 1 hour on days 1 8 15 and 22 Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity After 3 courses of treatment disease response is assessed Patients with stable or responding disease receive additional courses of treatment
After completion of study treatment patients are followed at 28 days and then every 3 months thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 15-25 patients will be accrued for this study within 12-18 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000415352 | REGISTRY | None | None |
| NCI-6500 | Registry Identifier | PDQ Physician Data Query | None |