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.

Condition	Treatment or Intervention	Phase
recurrent adult soft tissue sarcoma stage III adult soft tissue sarcoma stage IVA adult soft tissue sarcoma stage IVB adult soft tissue sarcoma	Drug: perifosine  Procedure: chemotherapy	Phase II

Further Study 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Arizona
      Mayo Clinic Scottsdale, Scottsdale,  Arizona,  85259,  United States
Florida
      Mayo Clinic, Jacksonville,  Florida,  32224,  United States
Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231,  United States
Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201,  United States
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
Missouri
      Washington University School of Medicine, Saint Louis,  Missouri,  63110,  United States
Wisconsin
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-6164,  United States

Study chairs or principal investigators

Howard H. Bailey, MD,  Study Chair,  University of Wisconsin Comprehensive Cancer Center   

Study ID Numbers:  CDR0000315381; MAYO-MC0276; NCI-5972
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  July 8, 2003
ClinicalTrials.gov Identifier:  NCT00064324
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08