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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00890110
First received: April 26, 2009
Last updated: April 28, 2009
Last verified: April 2009
  Purpose

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 Intervention Phase
Renal Cell Cancer
Biological: Autologous renal cell vaccine based on DNP modified cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • immunological response to therapy [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • patients progression free survival [ Time Frame: until end of 2011 ] [ Designated as safety issue: No ]
  • dermatologic and allergic reactions to vaccine injections [ Time Frame: during active treatments period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 13
Study Start Date: June 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890110

Contacts
Contact: Hovav Nechushtan, MD PhD 972-50-8946057 hovavnech@hadassha.org.il
Contact: zoya bezalel, BSC 6777825 zoyab@hadassah.org.il

Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Hovav Nechushtan, MD PHD Hadassah Medical Organization
  More Information

Additional Information:
Publications:
Responsible Party: Hovav Nechushtan - MD PhD attending Physician Oncology department, Hadassah Ein Kerem Medical center
ClinicalTrials.gov Identifier: NCT00890110     History of Changes
Other Study ID Numbers: RCC- vac-sut-1
Study First Received: April 26, 2009
Last Updated: April 28, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Renal cell cancer
sunitinib
autologous vaccine
metastatic RCC

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014