Perifosine in Treating Patients With Refractory Solid Tumors or Hematologic Cancer

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

Summary

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 perifosine in treating patients who have refractory solid tumors or hematologic cancer.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed solid tumor, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, myelodysplastic syndromes, or Hodgkin's lymphoma that has no effective standard therapeutic option but requires systemic therapy

• No history of CNS neoplasms

• For prostate cancer:

• Tumor progression during blockade of testicular and adrenal androgens

• At least 4 weeks since prior flutamide or other antiandrogens without disease improvement

• Leuprolide or other gonadotropin-releasing hormones should be maintained in patients without an orchiectomy

• Testosterone in the castrate range

• For breast cancer:

• At least 4 weeks since any prior hormonal therapy with evidence of disease progression

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Platelet count greater than 50,000/mm^3

• Absolute granulocyte count greater than 500/mm^3

• Hemoglobin at least 9.0 g/dL

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• SGOT and SGPT no greater than 2.5 times 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 past 6 months

• No New York Heart Association class II-IV heart disease

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• No recent acute or chronic gastrointestinal conditions (e.g., stomach ulcer or enteritis) that might affect tolerability or drug absorption

• No allergic reaction to any medication with a structure similar to perifosine

• No pre-existing retinal disease or pathologic baseline electrooculogram

• No cataracts that would interfere with normal vision or require medical intervention

• No other serious concurrent illness that would preclude assessment of drug effect

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

• At least 2 months since prior UCN-01

• More than 3 months since prior suramin

Endocrine therapy:

• See Disease Characteristics

• No concurrent corticosteroids except for physiological replacement or as antiemetics

Radiotherapy:

• At least 4 weeks since prior radiotherapy (6 weeks for bone-seeking radioisotopes) and recovered

Surgery:

• See Disease Characteristics

Other:

• No other concurrent antineoplastic therapies