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UCN-01 in Treating Patients With Advanced Cancer
This study has been completed.
Sponsors and Collaborators: Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003289
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of UCN-01 in treating patients with advanced cancer that has not responded to previous treatment.


Condition Intervention Phase
Leukemia
Lymphoma
Unspecified Adult Solid Tumor, Protocol Specific
Drug: 7-hydroxystaurosporine
Phase I

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma
Drug Information available for: UCN 01
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I and Pharmacologic Study of UCN-01 (NSC638850)

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 1998
Detailed Description:

OBJECTIVES: I. Determine the toxicity profile, dose limiting toxicity, and maximum tolerated dose of UCN-01 administered as a 3, 2, or 1 hour infusion every 4 weeks for patients with advanced solid tumor malignancies and chronic lymphoproliferative disorders. II. Investigate the pharmacokinetics and cellular pharmacodynamics of UCN-01 administered on this schedule in these patients. III. Obtain preliminary evidence of the antitumor activity of UCN-01 in this patient population.

OUTLINE: This is dose escalation study. Patients receive UCN-01 by intravenous infusions over 3, 2 or 1 hour(s) every 4 weeks. The first dose level is administered over 3 hours, the next dose level is administered over 2 hours, and the next and subsequent dose levels are administered over 1 hour. One patient is treated at each dose level until unacceptable toxicity is observed. An additional 2 patients are then entered at that dose level. If dose limiting toxicity (DLT) is experienced in 1 of 3 patients, 3 additional patients are accrued at that dose level. If 2 or more patients experience DLT, the maximum tolerated dose has been surpassed and a total of 6 patients must be treated at the previous dose level. If no patients develop DLT, the dose is escalated in successive cohorts of 3 patients per dose level. Patients are followed for 4 weeks after each drug administration before subsequent patients can be entered at the next higher dose level. Patients are followed for 2 months after their last dose of UCN-01.

PROJECTED ACCRUAL: Approximately 36 patients will be accrued into this study over 18 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed malignancy that is refractory to standard therapy or for which no standard therapy exists Low grade lymphoproliferative disorder defined as: Chronic lymphocytic leukemia/small lymphocytic lymphoma Waldenstrom's macroglobulinemia Follicular lymphoma (small cleaved, mixed, and large cell) Mantle cell lymphoma Prolymphocytic leukemia (T and B type) Cutaneous T cell non-Hodgkin's lymphoma Marginal zone lymphoma and variants Hairy cell leukemia variants MALT lymphomas Patients with low grade lymphoproliferative disorders must have received at least 1 or more treatment regimens and must not be eligible for potentially curative treatments (i.e., bone marrow transplantation) No HTLV-1 associated lymphomas, Burkitt's or small non-cleaved lymphomas, transplant related lymphoproliferative disorders, Hodgkin's disease, diffuse large cell lymphoma, or multiple myeloma No primary brain tumors or history of brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin at least 8.0 g/dL Hepatic: Bilirubin no greater than 1.2 mg/dL AST/ALT less than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of unstable or newly diagnosed angina pectoris No myocardial infarction within the last 6 months No New York Heart Association class II-IV congestive heart failure Neurologic: No grade 2 or greater peripheral neuropathy Pulmonary: No grade 2 or greater pulmonary toxicity (dyspnea on significant exertion) Other: HIV negative No autoimmune hemolytic anemia Must be able to have a central venous access catheter No active infections requiring oral or intravenous antibiotics No medical or psychiatric problems unrelated to the malignancy that may limit compliance with study, expose patient to undue risk, or confound toxicity assessment Not pregnant or nursing Adequate contraception is required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 month since prior platelet or red blood cell transfusions Chemotherapy: At least 6 weeks since nitrosoureas or mitomycin At least 4 weeks since other chemotherapy No investigational or standard chemotherapy for at least 2 months after completion of last dose of UCN-01 Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since radiotherapy Surgery: At least 4 weeks since major surgery Other: No concurrent anticonvulsant medications

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003289

Locations
United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: Ross C. Donehower, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000066221, JHOC-98012305, NCI-T97-0083
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00003289  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
Waldenstrom macroglobulinemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
refractory chronic lymphocytic leukemia
unspecified adult solid tumor, protocol specific
refractory hairy cell leukemia
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult diffuse mixed cell lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
prolymphocytic leukemia
stage III mantle cell lymphoma
stage IV mantle cell lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
stage III small lymphocytic lymphoma
stage III marginal zone lymphoma
stage IV small lymphocytic lymphoma
stage IV marginal zone lymphoma

Study placed in the following topic categories:
Leukemia, Lymphoid
Lymphoma, Mantle-Cell
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Lymphoma, B-Cell, Marginal Zone
Lymphoma, B-Cell
Leukemia
Leukemia, Prolymphocytic
Leukemia, Lymphocytic, Chronic, B-Cell
Staurosporine
Prolymphocytic leukemia
Waldenstrom macroglobulinemia
Lymphoma
Chronic lymphocytic leukemia
Immunoproliferative Disorders
Leukemia, B-cell, chronic
7-hydroxystaurosporine
Mantle cell lymphoma
Recurrence
Lymphatic Diseases
Leukemia, Hairy Cell
Waldenstrom Macroglobulinemia
B-cell lymphomas
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Hairy cell leukemia
Follicular lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009