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Home > "P" Clinical Trials Conditions > Perifosine in Treating Patients With Advanced Solid Tumors  Perifosine in Treating Patients With Advanced Solid Tumors
Perifosine in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , University of Wisconsin Comprehensive Cancer Center
Synopsis: RATIONALE: Perifosine may stop the growth of tumor cells by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of perifosine in treating patients who have advanced solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of perifosine on a loading dose/maintenance dose schedule in patients with advanced solid tumors. II. Determine the qualitative and quantitative toxic effects of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients. IV. Investigate the relationship between pharmacokinetic parameters and toxicity of this drug in these patients. V. Determine the recommended starting dose for phase II trials on this drug schedule in these patients. VI. Evaluate the pharmacodynamic parameters on peripheral blood lymphocytes both before and during drug administration in these patients. VII. Determine any changes in the MTD with prolonged administration (3 months, 6 months) of this drug in these patients. PROTOCOL OUTLINE: This is a dose-escalation study. Patients receive a loading dose of oral perifosine 4 times a day for 4-8 doses followed by a daily maintenance dose. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating loading doses and maintenance doses of perifosine until the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxic effects. PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed locally unresectable or metastatic malignancy that is considered incurable - Refractory to further treatment with known forms of effective therapy - No clinically active CNS metastasis --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent immunotherapy - Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered; No other concurrent chemotherapy - Endocrine therapy: No concurrent hormonal therapy; Patients who have progressive disease while being treated with LHRH agonists, antiestrogens, or antitestosterones for at least 3 months may remain on these agents if in their best interest - Radiotherapy: At least 4 weeks since prior radiotherapy; No concurrent radiotherapy - Surgery: See Disease Characteristics; At least 21 days since prior major surgery --Patient Characteristics-- - Age: 18 and over - Performance status: 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: WBC at least 4,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin normal; SGOT no greater than 2.5 times upper limit of normal - Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for at least 6 months after study; Maintaining a reasonable state of nutrition consistent with weight maintenance; No recent history of weight loss greater than 10% of current body weight; No frequent vomiting/poor alimentation; No other serious concurrent medical illness that would preclude study therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LynnUmmersen, Study Chair, University of Wisconsin Comprehensive Cancer Center
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
Additional Information:
Study ID Numbers: CDR0000067752; WCCC-CO-99906,NCI-T99-0036,ASTA-D-21266
Study Start Date: February 2000
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005794
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
2. AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors
3. BMS-214662 Plus Trastuzumab in Treating Patients With Advanced Solid Tumors
4. Irinotecan in Treating Aging Patients With Solid Tumors
5. Tributyrin in Treating Patients With Refractory Prostate Cancer or Other Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Wisconsin Clinical Trials
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Perifosine in Treating Patients With Advanced Solid Tumors
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