Protocol Number: 03-C-0157

Title:

A Phase II Study of Perifosine in Patients with Metastatic Androgen Independent Prostate Cancer

Number:

03-C-0157

Summary:

This study will evaluate the safety and effectiveness of perifosine in treating metastatic androgen-independent prostate cancer (advanced prostate cancer that does not respond to hormone therapy). Perifosine is one of a new class of anticancer drugs called alkylphospholipids (ALKS) that show broad anticancer activity in preclinical studies. Also, in preliminary clinical studies, perifosine stabilized prostate cancer in some patients.

Patients 18 years of age and older with advanced prostate cancer that does not respond to hormone therapy may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood tests, tumor biopsy if the tumor is accessible, and x-ray, CT & Bone scans to evaluate the location and extent of disease.

Participants will take perifosine in 28-day cycles. Each cycle consists of taking the drug by mouth for 21 days, stopping for 7 days, and then repeating the cycle. Depending on the response to treatment, therapy could last more than 6 months. Patients will keep a daily record of symptoms and drug side effects. Patients whose tumor does not grow during the first three cycles and who do not experience unacceptable treatment side effects will continue the 4-week cycles. Patients who develop unacceptable side effects will stop treatments. In addition to drug therapy, participants will undergo the following procedures:

- Physical examinations

- Blood tests every 28 days to measure drug levels, determine the effect of drug on tumor cells, and look for changes in chemical signals produced in response to the drug.

- Blood tests at home on day 15 of the first cycle of drug to make sure red & white blood cell counts and electrolytes as well as kidney & liver functions are not reaching harmful levels.

- Serial blood draws during the first month of treatment to measure blood levels of perifosine - Blood will be taken before the first drug dose and 8 and 48 hours after the dose. This first dose is a, loading dose, which is larger than the normal study dose. Patients will be admitted to the hospital for 4 days for the serial blood draws.

- Imaging studies (e.g., bone scan or CT scan) every 2 months for the first 4 months and every 3 months after that to determine the tumor response to therapy.

- Oral bushings of cells lining the inner surface of the cheeks, along with saliva samples taken before the first drug dose and on days 3 and 28 of treatment to study the effects of perifosine on cells.

- Tumor biopsies (in patients with accessible tumors) taken before treatment and 4 weeks after treatment begins. A biopsy is the surgical removal of a small piece of tumor tissue for microscopic examination.

- Leukapheresis before beginning treatment and days 3 and 28 of treatment to evaluate the effect of perifosine on blood cells. For this procedure a needle is placed in a vein and whole blood is collected. The blood flows through a cell separator machine where the mononuclear cells (a type of white blood cell) are removed for testing, and the rest of the blood is returned to the patient.

- Testosterone suppression to prevent tumor growth. Prostate cancer cells in the body may continue to grow if they are exposed to the male hormone testosterone. Testosterone is suppressed either surgically by removing the testicles, or medically with an injection of leuprolide or goserelin (leuteinizing hormone-release hormone, or LHRH agonist). LHRH agonists reduce testosterone levels.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Follow-up Of Previously Enrolled Subjects Only

Gender: Male

Referral Letter Required: No

Population Exclusion(s): Female

Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions: Currently Not Provided

Disease Category:

PROTICD

Keywords:

Chemotherapy

Alkylphospholipids

Keratinocytes

Pharmacokinetics

Gene Expression

Proteomics

Recruitment Keywords:

Melanoma

Conditions:

Prostate Cancer

Investigational Drug(s):

Perifosine

Investigational Device(s):

None

Contacts:

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citations:

Arthur G, Bittman R. The inhibition of cell signaling pathways by antitumor ether lipids. Biochim Biophys Acta. 1998 Feb 5;1390(1):85-102. Review. No abstract available. PMID: 9487143

Beedassy A, Cardi G. Chemotherapy in advanced prostate cancer. Semin Oncol. 1999 Aug;26(4):428-38. Review. PMID: 10482185

Brandt BH, Schmidt H, de Angelis G, Zanker KS. Predictive laboratory diagnostics in oncology utilizing blood-borne cancer cells--current best practice and unmet needs. Cancer Lett. 2001 Jan;162 Suppl:S11-S16. PMID: 11164185

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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Bethesda, Maryland 20892. Last update: 10/20/2004