Suspended

A Phase II Study of UCN-01 in Metastatic Melanoma

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What is being tested

7-hydroxystaurosporine

+ laboratory biomarker analysis

+ pharmacological study

DrugOther
Who is being recruted

Melanoma+8

+ Neoplasms

+ Neoplasms by Histologic Type

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 2003
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2003

Actual date on which the first participant was enrolled.

PRIMARY OBJECTIVES: I. To assess the anti-tumor activity of UCN-01 (7-hydroxystaurosporine) in metastatic melanoma, as determined by the response rate. II. To assess the clinical and laboratory toxicities of UCN-01. III. To study the effects of UCN-01 administration on potential markers of specific G1-phase cell cycle regulators. OUTLINE: This is a multicenter study. Patients receive UCN-01 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 17-33 patients will be accrued for this study within 18 months.

Official TitleA Phase II Study of UCN-01 in Metastatic Melanoma 
NCT00072189
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

17 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

MelanomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueSkin DiseasesSkin NeoplasmsNeuroectodermal TumorsNevi and MelanomasNeuroendocrine Tumors

Criteria

Inclusion Criteria: * Patients have histologically or cytologically confirmed melanoma that is incurable by other means such as surgery, radiotherapy, or limb perfusion * Patients must have measurable disease, defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 10 mm with conventional techniques or with spiral CT scan, and which has clearly progressed during the observation interval prior to participation in this study * Patients must have received =\< 1 prior chemotherapy and/or =\< biological therapies; isolated limb perfusion with a biological and/or chemotherapeutic agent is allowed if the measurable disease and the lesion that will be biopsied for this protocol are outside the area of prior perfusion; at least 4 weeks must have elapsed since prior therapy (6 weeks for nitrosoureas or mitomycin C) and the patient must have recovered from all toxicities attributable to prior therapy * Life expectancy greater than 4 months * Eastern Cooperative Oncology Group (ECOG) performance status #2 (Karnofsky \>= 60%) * Leukocytes \>= 3000/uL * Absolute neutrophil count \>= 1500/uL * Platelets \>= 100000/uL * Total bilirubin =\< 1.5 mg/dL * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2 X institutional upper limit of normal * Creatinine \< 1.6 mg/dL * Creatinine clearance \>= 50 mL/min for patients with creatinine levels above 1.6 mg/dL * The effects of UCN-01 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Ability to understand and willingness to sign a written informed consent document * Patient must have a central venous catheter * Patients are requested to submit archival tissue for pre-study and undergo a tumor biopsy 24 hours post UCN-01 administration if feasible Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or who have not recovered from adverse events to agents administered more than 4 weeks earlier * Patients must not be receiving any other investigational agents * Patients with known brain metastases are eligible only if disease is controlled and patient is asymptomatic (i.e. at least 4 weeks from completion of whole brain irradiation, stereotactic radiosurgery, or gamma knife irradiation) and not receiving corticosteroids * History of allergic reactions attributed to compounds of similar chemical or biologic composition to UCN-01 * Patients with only non-measurable disease, defined as all other lesions, including small lesions (longest diameter \>= 10 mm with conventional techniques or with spiral CT scan) and truly non-measurable lesions, which include the following: * Bone lesions * Leptomeningeal disease * Ascites * Pleural or pericardial effusion * Abdominal masses that are not confirmed and followed by imaging techniques * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, systematic congestive heart failure, symptomatic pulmonary diseases, unstable angina pectoris, cardiac arrhythmia, prior mediastinal radiation or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study because UCN-01 is a serine-threonine kinase inhibitor with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse effects in nursing infants secondary to treatment of the mother with UCN-01, breastfeeding should be discontinued if the mother is treated with UCN-01 * Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with UCN-01; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated * Due to the incidence of hyperglycemia with UCN-01, patients with a history of diabetes will be excluded from the study

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receive UCN-01 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

UC Davis Cancer Center

Sacramento, United StatesSee the location
SuspendedOne Study Center