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Recurrent MelanomaPhase 2NCT00072189

A Phase II Study of UCN-01 in Metastatic Melanoma

A Phase 2 study testing 7-hydroxystaurosporine, laboratory biomarker analysis and pharmacological study in people with Recurrent Melanoma and Stage IV Melanoma, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. This phase II trial is studying how well UCN-01 works in treating patients with metastatic melanoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Melanoma, Stage IV Melanoma
What is being tested?
7-hydroxystaurosporine, laboratory biomarker analysis and pharmacological study
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
Nov 2003to Mar 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UC Davis Cancer Center

    Sacramento, California, 95817

Other trials in United States

About this study

UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. This phase II trial is studying how well UCN-01 works in treating patients with metastatic melanoma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
7-hydroxystaurosporine, laboratory biomarker analysis, pharmacological study
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 7-hydroxystaurosporineDrug

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

  • pharmacological studyOther

    Correlative studies

Study groups in NCT00072189
Study groupRoleWhat they receive
Treatment (7-hydroxystaurosporine)ExperimentalPatients receive UCN-01 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: 7-hydroxystaurosporine; Other: laboratory biomarker analysis; Other: pharmacological study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response Rate

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

    Measured: Up to 7 years

Secondary outcomes (2)

  1. Overall Survival

    Estimated using the product-limit method of Kaplan and Meier.

    Measured: Up to 7 years

  2. Progression-free Survival

    Estimated using the product-limit method of Kaplan and Meier.

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: From the date of study registration to the first documentation of progressive tumor, assessed up to 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2003 (estimated)
  2. Study startNov 2003
  3. Primary completionMar 2010
  4. Study completionMar 2010

Why it stopped: Early termination for discouraging results

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00072189
Sponsor's protocol ID
NCI-2012-02829
Other IDs
NCI-2012-02829, PHII-33, 5536, N01CM17101
Status last verified
Oct 2013
First submitted
4 Nov 2003
Last updated
2 Mar 2015

Publications

  • Li T, Christensen SD, Frankel PH, Margolin KA, Agarwala SS, Luu T, Mack PC, Lara PN Jr, Gandara DR. A phase II study of cell cycle inhibitor UCN-01 in patients with metastatic melanoma: a California Cancer Consortium trial. Invest New Drugs. 2012 Apr;30(2):741-8. doi: 10.1007/s10637-010-9562-8. Epub 2010 Oct 22.

    PubMed 20967484

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 7-hydroxystaurosporine, laboratory biomarker analysis and pharmacological study in people with Recurrent Melanoma and Stage IV Melanoma, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Rate (time frame: Up to 7 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00072189, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2015.

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