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A Phase I/II Study To Examine The Safety, Feasibility, Immunological Response, And Measures Of Clinical Antitumor Activity After Administering Unselected, Autologous, Amplified Tumor Total RNA-Transfected, Dendritic Cell Vaccine (MB-002) To Patients With Metastatic Renal Cell Carcinoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Renal Cell Carcinoma

Thank you

Trial Information

A Phase I/II Study To Examine The Safety, Feasibility, Immunological Response, And Measures Of Clinical Antitumor Activity After Administering Unselected, Autologous, Amplified Tumor Total RNA-Transfected, Dendritic Cell Vaccine (MB-002) To Patients With Metastatic Renal Cell Carcinoma


Inclusion Criteria:



- Have a new diagnosis of metastatic renal cell carcinoma;

- Must be at least 18 years or older;

- Have a scheduled unilateral nephrectomy;

- ECOG of 0 or 1;

- Free of brain metastases by CT or MRI;

- Normal renal function in contralateral kidney;

- Male or non-pregnant/non-lactating female on appropriate birth control methods while
on study;

- Clinically acceptable screening results.

- No immunosuppressive therapy not limited to corticosteroids (including topical
steroids or steroid containing inhalers), azathioprine cyclosporine two months prior
to study entry;

- No active autoimmune disease

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To examine the safety of multiple administrations of MB-002 in patients with newly diagnosed, metastatic renal cell carcinoma.

Outcome Time Frame:

From registration until disease progression or withdrawal from study

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

MB-002-003

NCT ID:

NCT00087984

Start Date:

January 2004

Completion Date:

September 2008

Related Keywords:

  • Renal Cell Carcinoma
  • Kidney cancer
  • Renal cancer
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
University of California - IrvineOrange, California  92868
University of North Carolina at Chapel HillChapel Hill, North Carolina  27599