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Study Summary
No. 2005-0563:.......Sarcoma......Dejka M. Araujo......Sarcoma Medical Oncology
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Study Summary Title
Study Summary
Number:
2005-0563
Study Title:A Phase II Trial of Perifosine in Patients With Chemo-Insensitive Sarcomas
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Physician New Patient Referral
Name:Dejka M. AraujoPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Sarcoma Medical OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-3626
Contact us about clinical trials
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General Information
Disease Group:SarcomaSupported By:N/A
Phase of Study:Phase IIReturn
Visit:
Pre-study visit and then follow up clinic visit and blood work every 4 weeks
and prn.
Treatment
Agents:
PerifosineHome Care:Patients will self administer perifosine at home at bedtime. Supportive care
oral medications will be self administered at home as directed by treating
physician.
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this clinical research study is to learn if perifosine can help to
control chondrosarcoma, extra-skeletal chondrosarcoma, and alveolar soft part
sarcoma.
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Study Objectives / Outcomes
Primary: To evaluate the response rate of perifosine (100 mg qhs daily) in patients with chondrosarcoma, extra-skeletal myxoid chondrosarcoma, and alveolar soft part sarcoma.

Secondary: To determine the time to progression and the duration of stable disease in patients with chondrosarcoma, extra-skeletal myxoid chondrosarcoma, and alveolar soft part sarcoma taking perifosine (100 mg qhs daily).
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Study Status Information
Study Activation / Registration Date:11/27/2006
IRB Review and Approval Date:06/21/2006
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Closed
Projected Accrual:111
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Patients must have histologically or cytologically confirmed diagnosis of chondrosarcoma, extra-skeletal myxoid chondrosarcoma, or alveolar soft part sarcoma.

2) Patients may have had prior chemotherapy, but if the patient has had three or more forms of prior chemotherapy for metastases, the patient's clinical course should be discussed with the medical monitor or study chairman before the patient is enrolled on study.

3) Patients must have progression of disease by Choi criteria.

4) ECOG performance status 0-1. Patients with ECOG PS of 2 may be admitted with approval from the study chairman. Patients with a PS of 2 must meet criterion 1 and must be comfortable with the possibility of a transient period of tumor growth during the first weeks following the initiation of perifosine treatment.

5) At least 13 years of age.

6) Patients must have measurable disease. Patients who have brain metastases that have not progressed for at least 2 months following surgery or radiotherapy will be considered after discussion with the medical monitor.

7) Patients must have a life expectancy of more than 3 months.

8) Patients must have a normal organ and marrow function, unless in the opinion of the treating investigator, the abnormality is related to tumor, and the study chairman or medical monitor agree the abnormality is unlikely to affect the safety of perifosine use. Normal organ and marrow function is described below: HCT > 28% (with or without growth factor support), creatinine less than or equal to 2.5 mg/dl, total bilirubin < 1.5 x upper limit of normal and transaminase less than or equal to 2.5 x upper limit of normal.

9) Patients must have recovered from acute toxicity related to prior therapy, including surgery or radiotherapy to grade less than or equal to 1 (excluding alopecia ) at the time of enrollment.

10) Patients must be able to ingest oral medications or to obtain them through a gastrostomy tube.

11) Female patients who are pregnant or lactating are ineligible. All females of childbearing potential must have a negative urine or serum pregnancy test within 72 hours of treatment. Men and women of childbearing potential must agree to employ adequate contraception to prevent pregnancy while on therapy and for four weeks after the completion of treatment.

12) Patients must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:1) Patients receiving investigational or commercial agents or therapies administered with the intent to treat the patient's malignancy, except bisphosphonates.

2) History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).

3) Uncontrolled intercurrent illness—including, but not limited to, ongoing or active infection—and psychiatric illness/social situations that would limit compliance with study requirements.

4) HIV-positive patients will be allowed to participate on the protocol.

5) Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment) or New York Heart Assoc. class II-IV congestive heart failure.

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Links
Registration Number: NCT00401388
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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