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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001444
First Posted: November 4, 1999
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose
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.

Condition Intervention Phase
Breast Cancer Lymphoma Neoplasm Prostatic Neoplasm Drug: 7-hydroxystaurosporine (UCN-01) Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Trial of Continuous Infusion UCN-01 in Patients With Refractory Neoplasms

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 51
Study Start Date: August 1995
Estimated Study Completion Date: May 2002
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Patients must have a histologic diagnosis of a solid tumor or lymphoma confirmed by the Laboratory of Pathology, NCI and have failed standard chemotherapy.

No patients with leukemia, brain metastasis, or primary brain tumors.

Patients must be older than 18 years of age .

Must have a SGPT and SGOT less than 2.5 times the upper normal limits.

Liver tumor replacement should be less than 50% total liver surface.

Total bilirubin must be less than 1.5 times the upper limit and measured creatinine clearance of at least 55 ml/min.

Hemoglobin must be greater than 9.0.

Platelet count must be greater than 100,000, and absolute granulocyte count greater than 1,500.

PT/PTT must be within normal range.

Must have a performance status ECOG of 0-2.

Must have the ability to give informed consent.

Must have reliability to return for follow up and treatment, and to follow instructions.

The patient must not have received radiation therapy of chemotherapy within the past 4 weeks and have recovered from all toxicities prior to starting therapy.

Patients must not have received any nitrosureas, mitomycin C, or bone seeking radioisotopes within 6 weeks of entry.

Patients with prostate cancer:

Must have had tumor progression following blockade of both testicular and adrenal androgens.

If taking flutamide or any other anti-androgen, this will have to be discontinued at least four weeks prior to treatment with evidence of progression of disease following this maneuver.

Leuprolide or any other GnRh analog should be maintained if the patient has not had an orchiectomy.

All prostate cancer patients must have a serum testosterone in the castrate range.

Exposure to suramin:

Patients with prior exposure to suramin should be at least 3 months off therapy (from the last day of infusion) and have undetectable suramin levels.

Patients with breast carcinoma who are taking a hormonal treatment should discontinue this medication for at least 4 weeks prior to treatment with UCN-01 and have showed further progression of disease after this maneuver.

Patients may not be treated if any of the following is present:

Active infection, requiring antibiotics within 7 days prior to entry.

Bacterial colonization secondary to percutaneous nephrostomy tube, ileal pouch, or indwelling urinary catheter.

Positive serology for HIV.

Greater than grade I peripheral neuropathy at study entry.

Prior radiation therapy to greater than or equal to 30% of their bone marrow.

No patients with local complications which require urgent local therapy (e.g.: untreated hydronephrosis, impending spinal cord compression, severe bone pain unresponsive to analgesics).

No patients with a history of unstable or newly diagnoses angina pectoris, recent myocardial infarction (within 6 months of enrollment), class II-IV congestive heart failure, severe chronic obstructive lung disease (forced vital capacity less than 1000 ml).

No patients with uncontrolled seizure activity, controlled seizure activity but with less than one year free of seizures.

Patients with a past history of seizures must be seizure free for greater than a year and not taking any anticonvulsant medications.

No patients with coagulopathy or active renal disease.

No patients receiving steroids for other than physiologic replacement.

Effective June 10, 1998, patients with history of diabetes mellitus within 6 months of enrollment or fasting glucose greater than or equal to 116/mg/dl or Hemoglobin A1C greater than 6.5 mg/dl will not be eligible.

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001444


Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001444     History of Changes
Other Study ID Numbers: 950171
95-C-0171
First Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: March 4, 2008
Last Verified: May 2002

Keywords provided by National Institutes of Health Clinical Center (CC):
Pharmacokinetics
Natural Products
Salvage Therapy
Protein Kinase Antagonist

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
7-hydroxystaurosporine
Staurosporine
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action