Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-03-11 @ 1:18 PM
Study NCT ID:
NCT01009502
Status:
TERMINATED
Last Update Posted:
2013-11-08
First Post:
2009-11-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I/II Trial of Sodium Stibogluconate in Myelodysplastic Syndrome
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
SHP2 as a Therapeutic Target For Myelodysplastic Syndrome: Phase I/II Trial of Sodium Stibogluconate in Myelodysplastic Syndrome
Status:
TERMINATED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding, never moved into the phase II portion that was originally planned.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sodium stibogluconate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
This was originally designed as a phase I/II trial studying the side effects of sodium stibogluconate and how well it works in treating patients with myelodysplastic syndromes. Unfortunately, due to funding issues, the phase II portion was never conducted.
This was originally designed as a phase I/II trial studying the side effects of sodium stibogluconate and how well it works in treating patients with myelodysplastic syndromes. Unfortunately, due to funding issues, the phase II portion was never conducted.
Detailed Description:
Patients receive sodium stibogluconate IV over 30 minutes on days 1-5 and 15-19. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who respond to treatment may continue therapy until disease progression.
Patients undergo bone marrow aspiration, biopsy, and peripheral blood sample collection periodically for correlative laboratory studies.
After completion of study treatment, patients are followed up at 8 weeks.
The phase II portion of this trial was never conducted due to lack of funding.
Patients undergo bone marrow aspiration, biopsy, and peripheral blood sample collection periodically for correlative laboratory studies.
After completion of study treatment, patients are followed up at 8 weeks.
The phase II portion of this trial was never conducted due to lack of funding.
Study Oversight
Has Oversight DMC:
True
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?: