Autologous Vaccination of Stage 4 Renal Cell Carcinoma Combined With Sunitinib

NCT00890110 | Unknown Phase 1

• 1 other identifier: RCC- vac-sut-1
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Cell Cancer

Keywords

Renal cell cancer; sunitinib; autologous vaccine; metastatic RCC

Outcome Measures

Primary Outcomes (1)

• immunological response to therapy

  two years

Secondary Outcomes (2)

• patients progression free survival

  until end of 2011

• dermatologic and allergic reactions to vaccine injections

  during active treatments period

Study Arms (1)

Autologus vaccination with suntinib

EXPERIMENTAL

Combination of autologous dnp irradiated modified cells with sunitinib treatments

Biological: Autologous renal cell vaccine based on DNP modified cells

Interventions

Autologous renal cell vaccine based on DNP modified cells BIOLOGICAL

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

Also known as: autologous vaccine for rcc tumors with sunitinib

Autologus vaccination with suntinib

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Related Publications (3)

• Lotem M, Shiloni E, Pappo I, Drize O, Hamburger T, Weitzen R, Isacson R, Kaduri L, Merims S, Frankenburg S, Peretz T. Interleukin-2 improves tumour response to DNP-modified autologous vaccine for the treatment of metastatic malignant melanoma. Br J Cancer. 2004 Feb 23;90(4):773-80. doi: 10.1038/sj.bjc.6601563.

  PMID: 14970852 BACKGROUND

• Ko JS, Zea AH, Rini BI, Ireland JL, Elson P, Cohen P, Golshayan A, Rayman PA, Wood L, Garcia J, Dreicer R, Bukowski R, Finke JH. Sunitinib mediates reversal of myeloid-derived suppressor cell accumulation in renal cell carcinoma patients. Clin Cancer Res. 2009 Mar 15;15(6):2148-57. doi: 10.1158/1078-0432.CCR-08-1332. Epub 2009 Mar 10.

  PMID: 19276286 BACKGROUND

• Hutson TE, Figlin RA, Kuhn JG, Motzer RJ. Targeted therapies for metastatic renal cell carcinoma: an overview of toxicity and dosing strategies. Oncologist. 2008 Oct;13(10):1084-96. doi: 10.1634/theoncologist.2008-0120. Epub 2008 Oct 6.

  PMID: 18838439 BACKGROUND

Related Links

• just a sight describing all the publication in which the principle investigator had a contribution

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hovav Nechushtan, MD PHD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hovav Nechushtan, MD PhD

CONTACT

972-50-8946057; hovavnech@hadassha.org.il

zoya bezalel, BSC

CONTACT

6777825; zoyab@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 26, 2009
• First Posted: April 29, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 29, 2009

Record last verified: 2009-04