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A Phase II Trial of Perifosine Following Tyrosine Kinase Inhibitor Failure in Patients With Advanced Renal Cell Carcinoma

Phase 2
18 Years
Not Enrolling
Renal Cell Carcinoma

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Trial Information

A Phase II Trial of Perifosine Following Tyrosine Kinase Inhibitor Failure in Patients With Advanced Renal Cell Carcinoma

This is a single-arm phase II trial assessing the antitumor activity as measured by
progression free survival of perifosine in patients with metastatic RCC who have progressed
on sorafenib or sunitinib. A total of 48 patients will be enrolled in the trial. All
subjects will have histologically confirmed metastatic RCC with predominantly clear cell
features (≤ 50% other histologic features). Patients who have been taken off sorafenib or
sunitinib may only have been off therapy for less than three months prior to study
enrollment. Patients who remain on sorafenib or sunitinib may continue on drug at their
current dose until two weeks prior to the initiation of perifosine therapy.

The study consists of three periods: pre-treatment/screening, treatment, and follow-up. Day
1 will be defined as the first day of perifosine therapy. Patients will remain in the
treatment phase until progression or toxicity. Patients will be seen by an MD every 3 weeks
with 6 weeks defining one cycle of therapy. Tumor evaluations will occur every 6 weeks.

Inclusion Criteria:

- Patients will be required to have clear cell renal cell carcinoma with less than 50%
of any other histology (papillary or chromophobe or oncocytic). There must be
histologic confirmation by the treating center of either the primary or a metastatic

- Patients must have experienced disease progression by RECIST criteria while on
sorafenib or sunitinib

- Patients must be off of sorafenib or sunitinib for >= 2 weeks prior to initiation of
perifosine and <= 3 months prior to enrollment

- Patients may have had sorafenib or sunitinib in the adjuvant setting as long as they
have experienced disease recurrence while on therapy

- Patients must have measurable disease that is not curable by standard radiation
therapy or surgery

- Age >= 18 years

- ECOG performance status 0 or 1

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

Exclusion Criteria:

- History or clinical evidence of CNS disease, including primary brain tumor, seizures
not controlled with standard medical therapy, any brain metastasis, or history of

- Other than sorafenib or sunitinib, patients may have only had prior immunotherapy for
stage IV disease

- Patients may have had prior sorafenib OR sunitinib and cannot have been treated with
both TKIs

- Patients who have stopped sorafenib or sunitinib due to toxicity but have only
progressed off therapy will not be allowed

- Patients may have had prior anti-angiogenic such as bevacizumab only if given in
combination with either sorafenib or sunitinib

- Prior Thalidomide or IFNα are allowed for adjuvant therapy or stage IV disease

- Patients may not have had prior mTOR inhibitors (CCI-779, RAD001)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To estimate the progression free survival of TKI resistant patients with metastatic RCC who are treated with perifosine

Outcome Time Frame:

Every 6 weeks

Safety Issue:


Principal Investigator

Daniel Cho, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:

Perifosne 228



Start Date:

March 2007

Completion Date:

October 2011

Related Keywords:

  • Renal Cell Carcinoma
  • renal cell carcinoma
  • tyrosine kinase inhibitor failure
  • Carcinoma
  • Carcinoma, Renal Cell



Dana Farber Cancer Institute Boston, Massachusetts  02115
Investigative Site Beverly Hills, California  
Investigative Site Philadelphia, Pennsylvania  
Investigative Site Johnson City, Tennessee  37604