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Autologous Vaccination of Stage 4 Renal Cell Carcinoma Combined With Sunitinib (rcc)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00890110
Recruitment Status : Unknown
Verified April 2009 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : April 29, 2009
Last Update Posted : April 29, 2009
Information provided by:
Hadassah Medical Organization

Brief Summary:

While different lines of evidence support the notion that renal cell cancer is amenable for immunologic vaccination, up to now the clinical benefit associated with vaccines has been limited. One reason being probably the whole immunological state of the patients with RCC in which the tumor releases various substances promoting tolerance of the immune system towards the carcinoma. Recent data demonstrates that sunitinib has effects on the immune system which might enhance effectivity of anti tumor vaccines.

Since in kidney cancer it is quite common to resect primary tumor when there are few metastasis or or metastatic tumor resected (if there are few metastasis), the investigators plan to use these tumor source to grow autologous carcinoma cell lines and use a method used world wide for many years and in our institution for over a decade to modify these cells by dinitro phenol and use irradiated cell for patients vaccination in combination with sunitinib treatments.

The investigators will monitor clinical and immunological parameters in these patients.

Condition or disease Intervention/treatment Phase
Renal Cell Cancer Biological: Autologous renal cell vaccine based on DNP modified cells Phase 1 Phase 2

Detailed Description:

Background: Renal cell carcinoma (RCC) constitutes around 3% of all solid tumors and cure for metastatic sidease is reported for less than 5% of patients. Together with melanoma it is considered the most immune responsive tumor, moreover it is a common practice to resect primary tumor or large metastasis even in the metastatic settings. Antiangiogenesis treatments are currently the favored antitumor drugs, however their use has rarely resulted in complete response/ cure. Recently it has been demonstrated that these drugs can elicit a shift in the immune environment in RCC patients (improved T1 responses reduced Treg responses).Our department has experience in the treatment 200 melanoma patients with cellular vaccination and in the preparation of primary tumor cell lines from various tumors including RCC. Interestingly , immune modulators such as antiCTLA-4 Ab have demonstrated impressive activity in patients previously vaccinated with cellular vaccinations.

Working hypothesis: Vaccination with autologous cellular vaccines of RCC patients will induce clinical and immunological responses and help in formulation of better combined vaccination strategies in this cancer. Our aims are: 1) Growth and characterization of primary RCC cell lines,2)vaccination with autologous cellular vaccines in combination with sunitinib. 3) Clinical and immunologic characterizations for derivation of prognostic and predictive factors.

Methods: primary or metastatic tumor resected in one of several Israeli hospitals will be used to derive autologous cell lines used for vaccinations following DNP modifications in combination with the regular Sunitinib treatments. Immunological and clinical followup of the patients will be performed and primary cell lines will be grown for further in-vitro testing including possible future use for allogeneic vaccines. Expected result Good safety profile combined with significant clinical and immunological responses are expected.

Importance: This research might result in clinical benefit to the treated patients and will be important in the formulation of effective immune strategies in kidney cancer.

Probable implications to Medicine: RCC vaccine in combination with other therapies has the potential to lead to longer survival and even cure the proposed study will help in the formulation of such a vaccine.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase1/2 Study of Vaccination With DNP Modified Autologous Renal Cell Carcinoma in Combination With Sunitinib in Stage 4 RCC
Study Start Date : June 2009
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : December 2011

Arm Intervention/treatment
Experimental: Autologus vaccination with suntinib
Combination of autologous dnp irradiated modified cells with sunitinib treatments
Biological: Autologous renal cell vaccine based on DNP modified cells
Primary or metastatic tumor resected in an Israeli hospital will be used to derive autologous cell lines used for vaccinations following DNP modifications in combination with the regular Sunitinib treatments. Immunological and clinical followup of the patients will be performed
Other Name: autologous vaccine for rcc tumors with sunitinib

Primary Outcome Measures :
  1. immunological response to therapy [ Time Frame: two years ]

Secondary Outcome Measures :
  1. patients progression free survival [ Time Frame: until end of 2011 ]
  2. dermatologic and allergic reactions to vaccine injections [ Time Frame: during active treatments period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Metastatic renal cell cancer
  • Primary/metastatic tumor for which resection seems of potential clinical benefit and fresh tissue can be obtained
  • Patients for whom treatment with Sunitinib is the preferred clinical therapy
  • Ecog <2
  • Willingness to participate in the trial and contribute small amounts ( up to 100cc for all the trial) of blood for immunological monitoring
  • No concurrent active cancers ( excluding cancers which are not life threatening such as localized treated low grade prostate cancer,skin cancer etc)

Exclusion Criteria:

  • Age under 70
  • Life expectancy less than 3 months
  • Large tumor burden at multiple organs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00890110

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Contact: Hovav Nechushtan, MD PhD 972-50-8946057
Contact: zoya bezalel, BSC 6777825

Sponsors and Collaborators
Hadassah Medical Organization
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Principal Investigator: Hovav Nechushtan, MD PHD Hadassah Medical Organization
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Responsible Party: Hovav Nechushtan - MD PhD attending Physician Oncology department, Hadassah Ein Kerem Medical center Identifier: NCT00890110    
Other Study ID Numbers: RCC- vac-sut-1
First Posted: April 29, 2009    Key Record Dates
Last Update Posted: April 29, 2009
Last Verified: April 2009
Keywords provided by Hadassah Medical Organization:
Renal cell cancer
autologous vaccine
metastatic RCC
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action