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ChondrosarcomasPhase 2NCT00401388

A Trial of Perifosine in Patients With Chemo-Insensitive Sarcomas

A Phase 2 study testing Perifosine, Loperamide and Allopurinol in people with Chondrosarcomas and Alveolar Soft Part Sarcomas, run by AEterna Zentaris.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 years and older
What is being tested?
Perifosine, Loperamide and Allopurinol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
No sites listed yet
Study dates
Nov 2006to Oct 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
Show all 19Show fewer
  • 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.

Who cannot join

  • 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.

About this study

Official title: Sarcoma Alliance for Research Through Collaboration (SARC) Multicenter Trial: A Phase II Trial of Perifosine in Patients With Chemo-Insensitive Sarcomas

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.
Read the detailed description

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.

Perifosine is available in 50 mg tablets. Patients will take two perifosine 50 mg tablets orally once a day at bedtime with food. Administering the drug qhs has been shown to decrease gastrointestinal toxicity in some patients. Patients may need anti-emetics and/or anti-diarrheals. All patients may continue therapy unless disease progression is documented on two occasions at least 4 weeks apart. Patients who experience toxicity may continue on treatment with doses delayed or reduced. Evaluation of all lesions for progression or response will be made at 3-month intervals.

STUDY KEY POINTS

  • Treatment will be administered on an outpatient basis in 28-day cycles.
  • Growth factors should not be needed, however, use by patients on this trial is NOT prohibited.
  • A favorable outcome will be defined as a complete or partial response according to the Choi criteria or stable disease by the Choi criteria for 6 months or longer.
Being tested
Perifosine, Loperamide, Allopurinol, Antiemetics
Keywords
Chemo Insensitive Sarcomas, Chondrosarcomas, Alveolar soft part sarcomas, Extra skeletal myxoid chondrosarcomas, Perifosine
Medical subject headings
Chondrosarcoma, Sarcoma, Alveolar Soft Part

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PerifosineDrug

    Also called D-21266, KRX-0401

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

  • LoperamideOther

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

  • AllopurinolOther

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

  • AntiemeticsOther

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

Study groups in NCT00401388
Study groupRoleWhat they receive
Group A: chondrosarcomaExperimentalPatients 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).
Receives: Drug: Perifosine; Other: Loperamide; Other: Allopurinol; Other: Antiemetics
Group B: alveolar soft part sarcomaExperimentalPatients 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).
Receives: Drug: Perifosine; Other: Loperamide; Other: Allopurinol; Other: Antiemetics
Group C: extra-skeletal myxoidExperimentalPatients 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).
Receives: Drug: Perifosine; Other: Loperamide; Other: Allopurinol; Other: Antiemetics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

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

    Measured: >= 6 months

Secondary outcomes (2)

  1. Best overall response

    Best response recorded from the start of the treatment until disease progression/recurrence.

    Measured: >= 6 months

  2. Stable disease of six months or greater

    Stable disease is measured from the start of treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started.

    Measured: >= 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionJan 2011
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00401388
Sponsor's protocol ID
Perifosine 214
Status last verified
Feb 2012
First submitted
17 Nov 2006
Last updated
7 Mar 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Perifosine, Loperamide and Allopurinol in people with Chondrosarcomas and Alveolar Soft Part Sarcomas, run by AEterna Zentaris.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: >= 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00401388.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.

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