UCN-01 and Prednisone in Treating Patients With Solid Tumors or Lymphoma
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific
Intervention: 7-hydroxystaurosporine (Drug); prednisone (Drug); chemotherapy (Procedure); protein tyrosine kinase inhibitor therapy (Procedure); steroid therapy (Procedure)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: National Cancer Institute (NCI) Official(s) and/or principal investigator(s):
Giovanni Melillo, MD, Study Chair, Affiliation: National Cancer Institute - Frederick
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.
Clinical Details
Official title: A Phase I Trial Of UCN-01 And Prednisone In Patients With Refractory Solid Tumors And Lymphomas
Study design: Treatment
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Frederick Cancer Research and Development Center, Frederick, Maryland 21702-1201, United States
NCI - Center for Cancer Research, Bethesda, Maryland 20892, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland 20892-1182, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: June 2002
Last updated: October 25, 2007
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