Overview

Trial of Two Schedules of Perifosine for Patients With Solid Tumors or Lymphomas

Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
0
Participant gender:
All
Summary
This is a study of the drug perifosine for patients who have no standard treatment options. This study is designed to identify which cancer types respond to perifosine, and determine which regimen of perifosine is most effective in each one. Patients with either solid tumors or with lymphomas for whom this protocol represents reasonable or optimal treatment will be randomized to receive either perifosine 100 mg daily or 900 mg weekly until disease progression. Based on currently available data it is anticipated that these doses should be easily tolerated by most patients.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AEterna Zentaris
Criteria
Inclusion Criteria:

- Patients must have a histologically or cytologically confirmed diagnosis of either a
lymphoma or solid tumor for which there is no established therapy that, in the opinion
of the treating physician, will prolong the patient's survival or have a larger net
effect on the patient's quality of life.

- The physician must believe that the patient's course and the growth rate of the tumor
are such that the patient would feel comfortable continuing treatment for at least 12
weeks even if there were a transient period of modest tumor growth (defined as less
than 30%) during the first weeks following the initiation of perifosine treatment.

- Patients must have a life expectancy of more than 6 months.

- Patients must not be eligible for any other available perifosine study.

- In general, patients should have received no more than two prior cytotoxic
chemotherapy regimens for metastatic disease.

- Patients may have measurable or non-measurable disease. If the outcome for a patient
is to be based on response using Response Evaluation Criteria in Solid Tumors (RECIST)
criteria, the patient must have at least one measurable lesion that can be accurately
measured in at least one dimension and fit one of the following criteria: longest
diameter >= 20 mm using conventional techniques or >= 10 mm with spiral computed
tomography (CT) scan. The dimensions of all target lesions that will be used to
determine objective response along with the date of last measurement and the method of
measurement (e.g. physical examination, spiral CT, conventional CT) must be recorded
on the enrollment form prior to the patient's first treatment.

- If the outcome for a patient is to be based on an increase in time to progression, the
following will apply:

- The time to progression on the systemic treatment administered just prior to
enrollment in this trial must be carefully documented and should be 12 weeks or
more.

- There must have been a baseline tumor evaluation in which all sites of likely
metastases, based on signs and symptoms, were evaluated at the beginning of this
pre-protocol baseline time interval. (A total body CT scan or magnetic resonance
imaging [MRI] will usually suffice but are not required to meet this criterion).

- During the 12+ weeks in which the patient was progression-free, there must have
been no symptoms or signs of new metastases that warranted an evaluation,
undertaken or not.

- Progression of prior metastases or the appearance of new metastases must be
documented at the end of the progression-free 12+ week period.

- This prior progression-free interval must be recorded on the enrollment case
report form prior to the patient's first treatment.

- Patients should have a performance status of 0 to 1 according to the ECOG criteria.

- Patients must have adequate organ and marrow function. Adequate organ and marrow
function are described below.

- hematocrit (HCT) >= 28% (with or without growth factor support)

- creatinine <= 2.5 mg/dl

- total bilirubin <= 1.5x upper limit of normal

- transaminase <= 2.5x upper limit of normal

- Patients must have recovered from acute toxicity related to prior therapy including
surgery or radiotherapy, excluding alopecia.

- Patients with breast cancer or prostate cancer who discontinue endocrine therapy prior
to entry into this study must wait for a minimum of 1 month and then be reassessed for
a withdrawal response prior to starting perifosine. However, it is not a requirement
that endocrine therapies be discontinued.

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

- Patients must be at least 18 years of age

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

Exclusion Criteria:

- Rapidly progressing disease, as defined by progression within 12 weeks of initiation
of the previous regimen

- Patients receiving any other investigational agents or devices

- Patients who have recently (within 8 weeks) begun a new cancer treatment (e.g.,
bisphosphonates) that will be continued concomitantly with perifosine

- 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

- HIV-positive patients receiving combination anti-retroviral therapy are excluded from
the study because of possible pharmacokinetic interactions with perifosine.

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

- Female patients who are pregnant or lactating are ineligible.