NCT00001444

A Phase I Trial of Continuous Infusion UCN-01 in Patients With Refractory Neoplasms

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (planned)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a dosage escalation study to estimate the maximum tolerated dose of staurosporine analogue UCN-01. Groups of 3 to 6 patients receive a 72-hours intravenous continuous infusions of UCN-01 from day 1 to day 4 of each cycle the first cycle only, and over 36-hours on subsequent cycles. The side effects are allowed to disappear for up to 28 days. This cycle is repeated after evaluations and follow-ups, which are every 4 weeks, as long as the patient benefits.

Detailed description

Patients with relapsed or refractory neoplasms will be treated with escalating doses of UCN-01(7-hydroxystaurosporine) a protein kinase C inhibitor which also may affect cyclin-dependent kinase activity, given as a 72 hour infusion. This trial will determine the toxicity associated with the maximally tolerated dose of this drug in patients for whom no other therapeutic approach is deemed to be more useful.

Conditions

• Breast Cancer
• Lymphoma
• Neoplasm
• Prostatic Neoplasm

Interventions

Type	Name	Description
DRUG	7-hydroxystaurosporine (UCN-01)

Timeline

• Start date: 1995-08-01
• Completion: 2002-05-01
• First posted: 1999-11-04
• Last updated: 2008-03-04

Locations

1 site across 1 country: United States