Bevacizumab, Autologous Tumor/DC Vaccine, IL-2 and IFNα-2b in Metastatic Renal Cell Carcinoma (RCC) Patients

Part of paid clinical trials in Lebanon, New Hampshire.

Sponsor
Dartmouth-Hitchcock Medical Center
Study ID
NCT00913913
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DC vaccine — BIOLOGICAL
    DC Vaccine therapy 10E7 intranodally every cycle
  • Bevacizumab — DRUG
    Bevacizumab 10mg/kg iv every 2 weeks
  • IL-2 — BIOLOGICAL
    IL-2 18 MiU/m2 CI 5 days
  • IFN — BIOLOGICAL
    IFN 6 MiU subc TIW

Study Details

Immune therapies, such as a IL-2, for metastatic renal cell carcinoma (mRCC) are designed to mobilize immune effector cells that recognize and destroy cancer. The investigators have recently observed a 50% objective response rate (16% CR) in mRCC patients treated with autologous tumor lysate -dendritic cell (DC)-vaccine, IL-2 and interferon alfa (IFN). New agents inhibiting vascular endothelial growth factor (VEGF) pathways have demonstrated significant benefit in mRCC patients as well, but rarely induce CRs. High blood VEGF is associated with poor response to IL-2 and can cause tumor specific immune dysregulation. To test whether complementary mechanisms of immune activation and disruption of regulatory pathways enhance outcome the investigators plan to treat 24 mRCC patients in a phase II trial using bevacizumab, DC vaccine, IL-2, and IFN. Observations from this project will be used in the development of novel cancer therapies which, if successful, will decrease the burden of cancer on the public. The investigators propose to determine 1) the objective clinical response rate to treatment and progression free survival, 2) the clinical and autoimmune related toxicity profile of therapy, and 3) the treatment related tumor-specific immune response and the relationship of tumor-specific immune response and objective clinical response.

Key Dates

First listed
Jun 4, 2009
Start date
Feb 28, 2009
Status verified
Feb 2014
Primary completion
Jan 31, 2013
Completion
Jan 31, 2013

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: bevacizumab,IL-2, IFN, DC vaccine
    Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)

Primary Outcome Measure

Progression Free Survival [ Time Frame: 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-

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By research site
Dartmouth-Hitchcock Medical Center· Lebanon, NH

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