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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-08-31

Study Completion Date

2002-05-31

Brief Summary

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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.

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Detailed Description

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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

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Breast Cancer Lymphoma Neoplasm Prostatic Neoplasm

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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7-hydroxystaurosporine (UCN-01)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

If the patient is a premenopausal female she must have a negative pregnancy test (b-HCG) and be counseled concerning the necessity for effective contraception

No lactating females.

Both male and female patients must practice effective contraception while on study and for four months following its conclusion.

Eligible Sex

ALL

Accepts Healthy Volunteers

No