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

NCT00389077 | Completed Phase 2 DMC

• 1 other identifier: Perifosine 207
• Study Type: interventional
• Target: 558
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Tumors; Lymphomas

Keywords

perifosine; solid tumors; lymphomas; anticancer agent

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (PR + CR)

  To determine for each disease category the proportion of patients treated with perifosine who experience a favorable outcome, defined as a complete or partial response; a 50% increase in progression-free survival compared to patient's latest treatment regimen for metastatic disease, or stabilization of disease.

  Evaluated every 12 weeks

Secondary Outcomes (2)

• To Show that doses will be each sufficiently and tolerated

  From date of randomization

• To obtain plasma levels

  Every treatment cycle

Study Arms (2)

Perifosine Daily Dose

EXPERIMENTAL

Daily dose perifosine 50 mg.

Drug: Perifosine

Perifosine Twice Daily Dose

EXPERIMENTAL

Twice daily dose perifosine 50 mg.

Drug: Perifosine

Interventions

Perifosine DRUG

Perifosine 50 mg tablets

Also known as: D-21266, KRX-0401

Perifosine Daily Dose; Perifosine Twice Daily Dose

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• AEterna Zentaris: lead

Related Publications (1)

• 1) Journal of Clinical Oncology, 2009 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 27, No 15S (May 20 Supplement), 2009: e15505 / For HCC ( hepatic / sub-population) 2) Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 25, No 18S (June 20 Supplement), 2007: 15622 / For RCC (renal / sub-population)

  RESULT

MeSH Terms

Conditions

Neoplasms; Lymphoma

Interventions

perifosine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Timothy Goggins, MD

  Fox Valley Hematology and Oncology SC, Appleton

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: October 16, 2006
• First Posted: October 18, 2006
• Study Start: January 1, 2005
• Primary Completion: July 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 7, 2018

Record last verified: 2011-11