View Clinical Trial (Medical Research Study)
A Phase II Trial of Avastin and Temsirolimus Following Tyrosine Kinase Inhibitor Failure in Patients With Advanced Renal Cell Carcinoma
| City: |
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Nashville |
| State: |
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Tennessee |
| Zip Code: |
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37232 |
| Conditions: |
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Renal Cell Carcinoma - Kidney Cancer |
| Purpose: |
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The purpose of this research study is to find out the effects (good and bad) the study
treatment has on participants and their cancer. Temsirolimus has been approved by the Food
and Drug Administration (FDA) in the treatment of renal cell carcinoma. Avastin has been
approved by the FDA for other types of cancers but not renal cell carcinoma.
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| Study Summary: |
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- Participants will receive avastin on days 1 and 15 of each 28-day treatment cycle.
They will receive temsirolimus on days 1, 8, 15 and 22 of each cycle.
- During all treatment cycles, participants will have a physical exam, blood tests, and
urine test. An assessment of the tumor by CT (Computerized Tomography) scan will be
performed every 8 weeks.
- It is anticipated that participants will be in this research study for 5 years.
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| Criteria: |
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Inclusion Criteria:
- Histologically confirmed renal cell carcinoma in either primary or metastatic
lesions. Non-clear histology will be allowed.
- Disease progression on a VEGF-targeted tyrosine kinase inhibitor as the most recent
therapy or have experienced intolerable toxicity so as require discontinuation. Only
one prior VEGF-targeted tyrosine kinase inhibitor.
- Must be off of VEGF-targeted tyrosine kinase inhibitor for 2 weeks or greater.
- One measurable lesion which is not curable by standard radiation therapy or surgery.
- The enrolling site must agree to obtain paraffin-embedded tumor blocks or at least 10
unstained, paraffin-embedded slides for submission for correlative studies.
- 18 years of age or older
- ECOG Performance Status of 0 or 1
- Baseline laboratory values as outlined in the protocol
- Life expectancy of greater than 3 months
- No prior malignancy diagnosed within the past three years, other than superficial
basal cell and superficial squamous cell, or carcinoma in situ of the cervix.
Exclusion Criteria:
- Known CNS disease, except for treated brain metastases
- Previously treated with avastin or mTOR inhibitors
- Other then VEFG-targeted TKI, patients may only have had prior immunotherapy or
chemotherapy for stage IV disease
- History of allergic reaction to Chinese hamster ovary cell products, other
recombinant antibodies, or compounds of similar chemical or biologic composition to
avastin or temsirolimus
- History of bleeding diathesis or coagulopathy. Therapeutic anticoagulants are
allowed
- Patients with clinically significant cardiovascular disease
- Patients receiving enzyme-inducing antiepileptic drugs or any other CYP3A4 inducer
such as rifampin or St. John's wort
- No serious non-healing wound, ulcer or bone fracture
- No uncontrolled intercurrent illness including , but not limited to, ongoing active
infection requiring parental antibiotics or psychiatric illness/social situations
that would limit compliance with study requirements
- HIV-positive receiving combination anti-retroviral therapy
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to study enrollment or anticipation of need for major surgical procedure during
the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of vascular access
device, within 7 days prior to enrollment on study
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to study enrollment
- Known hypersensitivity to any component of avastin or temsirolimus
- Life expectancy of less than 12 weeks
- History of hemoptysis within 1 month prior to day 1
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| NCT ID: |
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NCT00782275 |
| Primary Contact: |
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Principal Investigator
Daniel Cho, MD
Beth Israel Deaconess Medical Center
Daniel Cho, MD
Phone: 617-632-9250
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| Backup Contact: |
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Biologic Therapy Program
Phone: 617-632-9250
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| Location Contact: |
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Nashville, Tennessee 37232
United States
Igor Pusanov, MD
Phone: 615-322-6053
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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