- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00064324
Perifosine in Treating Patients With Advanced Soft Tissue Sarcoma
A Phase II Study of Perifosine in Soft Tissue Sarcoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate the 6-month progression-free rate in patients treated with perifosine and having advanced soft tissue sarcoma.
SECONDARY OBJECTIVES:
I. To evaluate survival and time to progression. II. To evaluate objective tumor response status and duration. III. To evaluate adverse event rates. IV. To evaluate patterns of treatment failure. V. To evaluate pharmacokinetics.
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically confirmed advanced soft tissue sarcoma
- Measurable disease; measurable disease lesions that are being monitored for response and have been previously irradiated must have progressed > 25% since completion of radiation therapy
- Absolute neutrophil count (ANC) >= 1,500/uL
- PLT >= 100,000/uL
- Total bilirubin =< upper normal limit (UNL)
- AST =< 2.5 x UNL
- Creatinine =< UNL or calculated creatinine clearance >= 60 mL/min (i.e. using the Cockcroft-Gault or Jeliffe methods)
- Life expectancy >= 12 weeks
- ECOG performance status (PS) 0 or 1
- Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent
Exclusion Criteria:
Any of the following as this regimen may be harmful to a developing fetus or nursing child:
- Pregnant women
- Breastfeeding women
- Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)
- NOTE: Pregnant women are excluded from this study because perifosine is an alkylphospholipid with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with perifosine, breastfeeding should be discontinued if the mother is treated with perifosine
Any of the following:
- >= 3 prior cytotoxic chemotherapy regimens for metastatic sarcoma
- Chemotherapy =< 4 weeks prior to study entry
- Nitrosoureas or mitomycin C =< 6 weeks prior to study entry
- Radiotherapy =< 4 weeks prior to study entry
- Immunotherapy =< 4 weeks prior to study entry
- Biologic therapy =< 4 weeks prior to study entry
- Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation)
- Uncontrolled brain metastases; NOTE: these patients are excluded because of the poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events; however, if brain metastasis are treated and controlled for > 8 weeks, the patient would be eligible for this study
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrhythmia despite appropriate therapy, or psychiatric illness/social situations that would limit compliance with study requirements
- HIV-positive patients receiving combination anti-retroviral therapy; NOTE: these patients are excluded from the study because of possible pharmacokinetic interactions with perifosine; appropriate studies may be undertaken in patients receiving combination anti-retroviral therapy when indicated
Prior malignancy, except for the following:
- Adequately treated basal cell or squamous cell skin cancer
- Adequately treated noninvasive carcinoma
- Other invasive cancer from which the patient has been disease-free for 5 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I
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.
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Correlative studies
Correlative studies
Other Names:
Given orally
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free rate
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival time
Time Frame: Time from regstration to death due to any cause, assessed up to 5 years
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Estimated using the method of Kaplan-Meier (Kaplan and Meier 1958) and Cox Proportional Hazards (Cox D. 1972) modeling.
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Time from regstration to death due to any cause, assessed up to 5 years
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Time to disease progression
Time Frame: Time from registration to documentation of disease progression, assessed up to 5 years
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Estimated using the method of Kaplan-Meier (Kaplan and Meier 1958) and Cox Proportional Hazards (Cox D. 1972) modeling.
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Time from registration to documentation of disease progression, assessed up to 5 years
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Duration of response
Time Frame: Date at which the patient's objective status is first noted to be either a complete response (CR) or partial response (PR) to the date progression is documented, assessed up to 5 years
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Date at which the patient's objective status is first noted to be either a complete response (CR) or partial response (PR) to the date progression is documented, assessed up to 5 years
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Time to treatment failure
Time Frame: Time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 5 years
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Time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 5 years
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Average change over time for PK variable(s)
Time Frame: Days 1 and 15 of course 1 and day 1 of courses 2-6
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Estimated and tested via appropriate methods (i.e.
t-test or Wilcoxon tests).
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Days 1 and 15 of course 1 and day 1 of courses 2-6
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Howard Bailey, Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCI-2012-02798
- N01CM17104 (U.S. NIH Grant/Contract)
- 5972
- MC0276
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrent Adult Soft Tissue Sarcoma
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Radiation Therapy Oncology GroupNational Cancer Institute (NCI)WithdrawnRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IVA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue SarcomaUnited States, Canada
-
National Cancer Institute (NCI)TerminatedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage I Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue SarcomaUnited States
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National Institutes of Health Clinical Center (CC)CompletedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IVA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue Sarcoma | Stage IVB Adult Soft Tissue Sarcoma
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National Cancer Institute (NCI)TerminatedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue SarcomaUnited States
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Northwestern UniversityAVEO Pharmaceuticals, Inc.CompletedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue SarcomaUnited States
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National Cancer Institute (NCI)CompletedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue SarcomaUnited States
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National Cancer Institute (NCI)National Comprehensive Cancer NetworkCompletedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue SarcomaUnited States
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National Cancer Institute (NCI)Radiation Therapy Oncology GroupTerminatedRecurrent Adult Soft Tissue Sarcoma | Stage I Adult Soft Tissue Sarcoma AJCC v7 | Stage II Adult Soft Tissue Sarcoma AJCC v7 | Stage III Adult Soft Tissue Sarcoma AJCC v7United States
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City of Hope Medical CenterTerminatedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Adult LiposarcomaUnited States
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National Cancer Institute (NCI)CompletedRecurrent Osteosarcoma | Metastatic Osteosarcoma | Recurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue SarcomaUnited States, Canada
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