Renal Cell Carcinoma Clinical Trial
Official title:
A Phase II Trial of Perifosine Following Tyrosine Kinase Inhibitor Failure in Patients With Advanced Renal Cell Carcinoma
Verified date | February 2012 |
Source | AEterna Zentaris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a single-arm phase II trial of perifosine in renal cancer patients who have experienced disease progression after receiving either sorafenib or sunitinib.
Status | Completed |
Enrollment | 24 |
Est. completion date | October 2011 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 lesion - 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 stroke - 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 IFNa are allowed for adjuvant therapy or stage IV disease - Patients may not have had prior mTOR inhibitors (CCI-779, RAD001) |
Country | Name | City | State |
---|---|---|---|
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Investigative Site | Duarte | California |
United States | Investigative Site | Nashville | Tennessee |
United States | Investigative Site | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
AEterna Zentaris | Dana-Farber Cancer Institute |
United States,
Journal of Clinical Oncology, 2009 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 27, No 15S (May 20 Supplement), 2009: 5101
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To estimate the progression free survival | To estimate the progression free survival of Multi-Targeted Kinase Inhibitor (TKI) resistant patients with metastatic Renal Cell Carcinoma (RCC) who are treated with perifosine | Every 6 weeks | |
Secondary | To determine the objective response rate of perifosine | To determine the objective response rate of TKI resistant patients with metastatic RCC treated with perifosine. | Every 6 weeks | |
Secondary | To investigate the tolerability and toxicity | To investigate the tolerability and toxicity of perifosine in TKI resistant patients | Every 6 weeks | |
Secondary | To investigate surrogates of biologic target inhibition | To investigate surrogates of biologic target inhibition on PBMC's before and after therapy. | Every 6 weeks | |
Secondary | To collect pre-treatment tissue specimens | To collect pre-treatment tissue specimens and assess the pre-treatment activation status of the MAP-Kinase and PI3K-Akt pathways and correlate with clinical outcome. | Every 6 weeks | |
Secondary | To follow levels of pro-angiogenic cytokines | To follow levels of pro-angiogenic cytokines and surrogates of HIF activation before and during therapy. | Every 6 weeks |
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