A Trial of Perifosine in Patients With Chemo-Insensitive Sarcomas

NCT00401388 | Completed Phase 2 DMC

• 1 other identifier: Perifosine 214
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Chemo Insensitive Sarcomas; Chondrosarcomas; Alveolar soft part sarcomas; Extra skeletal myxoid chondrosarcomas; Perifosine

Outcome Measures

Primary Outcomes (1)

• Response rate

  To investigate whether perifosine has a response rate of \> 20% in this group of patients with chemo-insensitive sarcomas.

  >= 6 months

Secondary Outcomes (2)

• Best overall response

  >= 6 months

• Stable disease of six months or greater

  >= 6 months

Study Arms (3)

Group A: chondrosarcoma

EXPERIMENTAL

Patients with sarcoma subtype: histologically or cytologically confirmed diagnosis of chondrosarcoma. Supportive Care Guidelines for perifosine include antiemetic prophylaxis (antiemetics will be administered at the treating investigator's discretion), diarrhea management (loperamide), and hyperuricemia prophylaxis (allopurinol).

Drug: Perifosine; Other: Loperamide; Other: Allopurinol; Other: Antiemetics

Group B: alveolar soft part sarcoma

EXPERIMENTAL

Patients with sarcoma subtype: histologically or cytologically confirmed diagnosis of alveolar soft part sarcoma. Supportive Care Guidelines for perifosine include antiemetic prophylaxis (antiemetics will be administered at the treating investigator's discretion), diarrhea management (loperamide), and hyperuricemia prophylaxis (allopurinol).

Drug: Perifosine; Other: Loperamide; Other: Allopurinol; Other: Antiemetics

Group C: extra-skeletal myxoid

EXPERIMENTAL

Patients with sarcoma subtype: histologically or cytologically confirmed diagnosis of extra-skeletal myxoid chondrosarcoma. Supportive Care Guidelines for perifosine include antiemetic prophylaxis (antiemetics will be administered at the treating investigator's discretion), diarrhea management (loperamide), and hyperuricemia prophylaxis (allopurinol).

Drug: Perifosine; Other: Loperamide; Other: Allopurinol; Other: Antiemetics

Interventions

Perifosine DRUG

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

Also known as: D-21266, KRX-0401

Group A: chondrosarcoma; Group B: alveolar soft part sarcoma; Group C: extra-skeletal myxoid

Loperamide OTHER

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

Group A: chondrosarcoma; Group B: alveolar soft part sarcoma; Group C: extra-skeletal myxoid

Allopurinol OTHER

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

Group A: chondrosarcoma; Group B: alveolar soft part sarcoma; Group C: extra-skeletal myxoid

Antiemetics OTHER

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

Group A: chondrosarcoma; Group B: alveolar soft part sarcoma; Group C: extra-skeletal myxoid

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AEterna Zentaris: lead
• Sarcoma Alliance for Research through Collaboration: collaborator

MeSH Terms

Conditions

Chondrosarcoma; Sarcoma, Alveolar Soft Part

Interventions

perifosine; Loperamide; Allopurinol; Antiemetics

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Neoplasms, Muscle Tissue

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Gastrointestinal Agents

Study Officials

• Dejka Araujo, MD

  MD Anderson Cancer Center, Dept of Sarcoma

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: One treatment arm: Perifosine. Three groups related to sarcoma subtype: histologically or cytologically confirmed diagnosis of (a) chondrosarcoma, (b) alveolar soft part sarcoma and (c) extra-skeletal myxoid chondrosarcoma.

Study Record Dates

• First Submitted: November 17, 2006
• First Posted: November 20, 2006
• Study Start: November 1, 2006
• Primary Completion: January 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 7, 2018

Record last verified: 2012-02