Know Cancer

forgot password

A Phase II Study of UCN-01 in Metastatic Melanoma

Phase 2
18 Years
Not Enrolling
Recurrent Melanoma, Stage IV Melanoma

Thank you

Trial Information

A Phase II Study of UCN-01 in Metastatic Melanoma


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

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

Up to 7 years

Safety Issue:


Principal Investigator

Scott Christensen

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

November 2003

Completion Date:

Related Keywords:

  • Recurrent Melanoma
  • Stage IV Melanoma
  • Melanoma



City of Hope Duarte, California  91010