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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: 7-hydroxystaurosporine; Prednisone; Staurosporine

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