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Home > "P" Clinical Trials Conditions > Perifosine in Treating Patients With Advanced Soft Tissue Sarcoma  Perifosine in Treating Patients With Advanced Soft Tissue Sarcoma
Perifosine in Treating Patients With Advanced Soft Tissue Sarcoma
For Condition: stage 4B adult soft tissue sarcoma,stage 4A adult soft tissue sarcoma,stage 3 adult soft tissue sarcoma,recurrent adult soft tissue sarcoma
Status: No longer recruiting
Sponsor(s): Mayo Clinic Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as perifosine use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have advanced soft tissue sarcoma.
Details: OBJECTIVES: - Determine the 6-month progression-free rate, time to progression, and survival of patients with advanced soft tissue sarcoma treated with perifosine. - Determine the objective tumor response status and duration of response in patients treated with this drug. - Determine the pharmacokinetics of this drug in these patients. - Determine the patterns of treatment failure and adverse event rate in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive a loading dose of oral perifosine every 6 hours for a total of 4 doses on day 1 and once daily on days 2-28 of course 1 only. For all subsequent courses, patients receive oral perifosine once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 5 years. PROJECTED ACCRUAL: A total of 17-46 patients will be accrued for this study within 9-12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed advanced soft tissue sarcoma - Measurable disease - Lesions that have been previously irradiated must have progressed at least 25% since prior radiotherapy - No uncontrolled brain metastases - Previously treated brain metastases are allowed provided they are controlled for more than 8 weeks prior to study entry PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than upper limit of normal (ULN) - AST no greater than 2.5 times ULN Renal - Creatinine no greater than ULN OR - Creatinine clearance at least 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No symptomatic cardiac arrhythmia despite appropriate therapy Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergic reactions attributed to compounds of similar chemical or biological composition to perifosine - No other concurrent uncontrolled illness - No ongoing or active infection - No psychiatric illness or social situations that would preclude study compliance - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma PRIOR CONCURRENT THERAPY: Biologic therapy - More than 4 weeks since prior biologic therapy - More than 4 weeks since prior immunotherapy - No concurrent immunotherapy - No concurrent immunomodulating agents Chemotherapy - No more than 2 prior cytotoxic chemotherapy regimens for metastatic sarcoma - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - More than 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - Recovered from prior therapy - No concurrent combination antiretroviral therapy for HIV-positive patients - No concurrent commercial or other investigational agents or therapies for the malignancy - No other concurrent cytostatic or cytotoxic agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HowardBailey, Study Chair, University of Wisconsin Comprehensive Cancer Center
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
United States
Additional Information:
Study ID Numbers: CDR0000315381; MAYO-MC0276,NCI-5972
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064324
Other Stage 4a Adult Soft Tissue Sarcoma Studies:
1. Flavopiridol in Treating Patients With Recurrent, Locally Advanced, or Metastatic Soft Tissue Sarcoma
2. Irinotecan in Treating Patients With Stage IV or Recurrent Soft Tissue Sarcoma
3. Ecteinascidin 743 in Treating Patients With Unresectable Advanced or Metastatic Soft Tissue Sarcoma
4. Holmium Ho 166 DOTMP Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Ewing's Sarcoma or Rhabdomyosarcoma That Has Spread to the Bone
5. CP4071 in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
Related Studies:
Other stage 4A adult soft tissue sarcoma Clinical Trials
Other Arizona Clinical Trials
Other Scottsdale Clinical Trials
Perifosine in Treating Patients With Advanced Soft Tissue Sarcoma
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