A Trial of Perifosine in Patients With Chemo-Insensitive Sarcomas

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II study of perifosine in patients with chondrosarcomas, alveolar soft part sarcomas and extra-skeletal myxoid chondrosarcomas. Patients will receive perifosine 100 mg orally qhs with food until disease progression. The goals of this study include:

• In this study a daily dose of perifosine previously determined to be relatively non-toxic will be evaluated in patients with chondrosarcomas, alveolar soft part sarcomas and extra-skeletal myxoid chondrosarcomas.

• Response to therapy will be based on regression of measurable disease according to Choi criteria. Time to progression and duration of stable disease will be measured as secondary endpoints of the study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AEterna Zentaris
• Collaborator: Sarcoma Alliance for Research through Collaboration
• Treatments: Allopurinol; Antidiarrheals; Antiemetics; Loperamide

Criteria

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed diagnosis of chondrosarcoma, extra-skeletal myxoid chondrosarcoma or alveolar soft part sarcoma.

• 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 study chairman before the patient is enrolled on study

• Patients must have progression of disease by Choi criteria.

• ECOG performance status 0-1. Patients with ECOG PS of 2 may be admitted with approval from the study chairman.

• At least 13 years of age.

• 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 study chairman.

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

• Patients must have normal organ and marrow function, unless in the opinion of the treating investigator, the abnormality is related to tumor, and the study chairman agree the abnormality is unlikely to affect the safety of perifosine use. Normal organ and marrow function is described below:

• ANC >1.5 x 109 /L

• Platelets >75,000/ mm3

• HCT > 28% (with or without growth factor support)

• Creatinine <= 2.5 mg/dl

• Total bilirubin < 1.5 x upper limit of normal

• Transaminase <= 2.5 x upper limit of normal

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

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

• 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.

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

Exclusion Criteria:

• Patients receiving investigational or commercial agents or therapies administered with the intent to treat the patient's malignancy, except bisphosphonates.

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

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

• 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.