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UCN-01 and Prednisone in Treating Patients With Solid Tumors or Lymphoma

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ClinicalTrials.gov Identifier: NCT00045500
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 30, 2015
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE September 6, 2002
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date April 30, 2015
Study Start Date  ICMJE June 2002
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE UCN-01 and Prednisone in Treating Patients With Solid Tumors or Lymphoma
Official Title  ICMJE A Phase I Trial Of UCN-01 And Prednisone In Patients With Refractory Solid Tumors And Lymphomas
Brief Summary

RATIONALE: UCN-01 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining UCN-01 with prednisone may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with prednisone in treating patients who have refractory solid tumors or lymphoma.

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose of UCN-01 in combination with prednisone in patients with refractory solid tumors or lymphomas.
  • Determine the toxic effects of this regimen in these patients.
  • Assess the pharmacokinetics of this regimen in these patients.
  • Assess any tumor response in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of UCN-01.

Patients receive oral prednisone daily on days 1-5 and UCN-01 IV over 36-72 hours on days 3-5. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of UCN-01 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the recommended phase II dose.

Patients are followed every 3-12 months for 5 years.

PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study within 18 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Lymphoma
  • Unspecified Adult Solid Tumor, Protocol Specific
Intervention  ICMJE
  • Drug: 7-hydroxystaurosporine
  • Drug: prednisone
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed solid tumor or lymphoma

    • Progressive disease after standard therapy
    • No other therapy is likely to improve survival
  • Prostate cancer patients must have progressed through hormonal therapy with gonadotropin-releasing hormone (GnRH) agonists and withdrawal of testosterone receptor antagonists

    • Patients must continue on GnRH agonist during study (if orchiectomy has not been performed) and have castrate testosterone levels
  • Brain metastases allowed if treated and the patient has been stable off anti-seizure medication or steroids for > 6 months
  • No local complications from disease requiring urgent therapy (i.e., hydronephrosis, spinal cord compression, or severe pain requiring improved pain management)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months

Hematopoietic

  • Absolute neutrophil count greater than 1,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • 12-hour fasting glucose no greater than 110 mg/dL OR
  • 12-hour fasting glucose no greater than 140 mg/dL with hemoglobin A1C no greater than 6.5 mg/dL

Hepatic

  • PT/PTT no greater than 1.5 times upper limit of normal (ULN)
  • Bilirubin no greater than 1.5 times ULN (unless Gilbert's syndrome present)
  • AST/ALT no greater than 2.5 times ULN

Renal

  • Creatinine clearance greater than 60 mL/min OR
  • Creatinine no greater than 1.5 mg/dL

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris

Pulmonary

  • No interstitial lung disease within the past year
  • No requirement for oxygen therapy for hypoxia in the past 6 months

Gastrointestinal

  • No diagnosis of duodenal or gastric ulcer
  • No severe gastritis within the past 6 months

Other

  • HIV negative
  • No prior allergic reactions to other indolocarbazoles
  • No diabetes or hyperglycemia within the past year that required a diabetic diet, oral hypoglycemics, or insulin
  • No other uncontrolled illness
  • No active infection
  • No seizure disorder
  • No psychiatric illness that would preclude study compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 2 months after study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No prior UCN-01

Endocrine therapy

  • See Disease Characteristics
  • No other concurrent oral or IV steroids

Radiotherapy

  • At least 4 weeks since prior radiotherapy and recovered

Surgery

  • See Disease Characteristics
  • At least 21 days since prior major surgery

Other

  • See Disease Characteristics
  • At least 4 weeks since prior investigational agents
  • No other concurrent anticancer therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00045500
Other Study ID Numbers  ICMJE CDR0000256599
NCI-02-C-0241
NCI-5694
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Giovanni Melillo, MD National Cancer Institute - Frederick
PRS Account National Cancer Institute (NCI)
Verification Date August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP