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A Trial of Perifosine in Patients With Chemo-Insensitive Sarcomas

NCT00401388 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2018-03-07

No results posted yet for this study

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.

Conditions

  • Chondrosarcomas
  • Alveolar Soft Part Sarcomas
  • Extra Skeletal Myxoid Chondrosarcomas

Interventions

DRUG

Perifosine

Perifosine is available in 50 mg tablets. Patients will take two perifosine 50 mg tablets orally once a day at bedtime with food.

OTHER

Loperamide

All patients should be instructed to take loperamide at the earliest signs of diarrhea and/or abdominal cramping after beginning perifosine.

OTHER

Allopurinol

Patients with a known history of hyperuricemia and/or gout should receive prophylactic treatment with allopurinol 300 mg po daily.

OTHER

Antiemetics

Antiemetic prophylaxis will be administered at the treating investigator's discretion.

Sponsors & Collaborators

  • Sarcoma Alliance for Research through Collaboration

    collaborator OTHER

  • AEterna Zentaris

    lead INDUSTRY

Principal Investigators

  • Dejka Araujo, MD · MD Anderson Cancer Center, Dept of Sarcoma

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2011-01-31
Completion
2011-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00401388 on ClinicalTrials.gov