Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132015
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
2005-08-16
Brief Title:
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Systemic Mastocytosis
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Clinical Trial of 17-Allylamino-17- Demethoxygeldanamycin 17-AAG NSC 330507 and EPL Diluent NSC 704057 in Adults With Systemic Mastocytosis
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 17-AAG 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-AAG works in treating patients with systemic mastocytosis
PURPOSE This phase II trial is studying how well 17-AAG works in treating patients with systemic mastocytosis
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG in terms of decreases in the number of mast cells in the bone marrow and in serum tryptase levels in patients with systemic mastocytosis
Secondary
Determine the quality of life of patients treated with this drug
Determine hematological and non-hematological toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive 17-N-allylamino-17-demethoxygeldanamycin 17-AAG IV over 2-6 hours on days 1 4 8 and 11 Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive at least 2 additional courses beyond CR Patients achieving a partial response receive at least 4 additional courses beyond their maximum response Selected patients may receive additional courses of therapy beyond the protocol guidelines at the discretion of the principal investigator
Quality of life is assessed at baseline and before each treatment course
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within approximately 10-18 months
Primary
Determine the efficacy of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG in terms of decreases in the number of mast cells in the bone marrow and in serum tryptase levels in patients with systemic mastocytosis
Secondary
Determine the quality of life of patients treated with this drug
Determine hematological and non-hematological toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive 17-N-allylamino-17-demethoxygeldanamycin 17-AAG IV over 2-6 hours on days 1 4 8 and 11 Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive at least 2 additional courses beyond CR Patients achieving a partial response receive at least 4 additional courses beyond their maximum response Selected patients may receive additional courses of therapy beyond the protocol guidelines at the discretion of the principal investigator
Quality of life is assessed at baseline and before each treatment course
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within approximately 10-18 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 |
|---|---|---|---|
| 06-C-0076 | None | None | None |
| NCI-6454 | None | None | None |
| NCI-P6175 | None | None | None |
| CDR0000438778 | None | None | None |