Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	NCI-02-C-0241 NCI-5694, 5694, NCT00045500

Objectives

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

Entry 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)

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

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/mm³
• Platelet count greater than 100,000/mm³
• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Giovanni Melillo, MD, Protocol chair		Ph: 301-846-5050

Registry Information
Official Title		A Phase I Trial Of UCN-01 And Prednisone In Patients With Refractory Solid Tumors And Lymphomas
Trial Start Date		2002-06-27
Trial Completion Date		2010-01-20
Registered in ClinicalTrials.gov		NCT00045500
Date Submitted to PDQ		2002-07-09
Information Last Verified		2005-08-17

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