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A Phase 2, Multicenter, Randomized, Single-Blind Study of Vitespen (HSPPC-96, Oncophage)for Immune Response Assessment Following Treatment of Patients With Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence


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

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Trial Information

A Phase 2, Multicenter, Randomized, Single-Blind Study of Vitespen (HSPPC-96, Oncophage)for Immune Response Assessment Following Treatment of Patients With Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence


A multicenter, randomized, single-blind study to assess patients' immune response following
treatment with HSPPC-96 (vitespen, Oncophage®)for resectable renal cell carcinoma (RCC),
considered to be at intermediate risk for recurrence given the pathologic tumor stage at
time of resection.

The purpose of this study is to determine whether patients exhibit a measurable and durable
immune response after multiple administrations of HSPPC-96 during a maximum 15-month time
period.

The study consists of two parts: Part 1 with Part 1a (Assessment of Immune Variation)and
Part 1b (Assay Standardization), and Part 2 (Immune Monitoring Study).


Inclusion Criteria:



- confirmation of histological diagnosis of RCC with evidence of >/= 25% clear cell
carcinoma

- AJCC TNM tumor stage at intermediate risk for recurrence

- at least 8 doses of vaccine available from patient's tumor

- life expectancy of at least 3 months

- ECOG PS of 0 or 1

- Cardiovascular disease status of NYHA class less than 2

- adequate hematopoietic, renal and hepatic function

- negative serology tests for HIV, HTLV-1, HBsAg, anti-HCV-Ab

- females must have negative pregnancy test

Exclusion Criteria:

- evidence of metastatic or residual RCC

- documented radiological enlarged lymph nodes

- females who are pregnant or breastfeeding

- use of any other investigational product from 4 weeks post-surgery

- splenectomy performed during nephrectomy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

immunological response in blood sample using ELISPOT assay

Outcome Time Frame:

15 months

Safety Issue:

No

Principal Investigator

Louis Lacombe, MD, FRCSC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Service d'Urologie; Centre hospitalier universitaire de Quebec - Hotel-Dieu de Quebec

Authority:

United States: Food and Drug Administration

Study ID:

C-100-38

NCT ID:

NCT01147536

Start Date:

January 2010

Completion Date:

June 2012

Related Keywords:

  • Renal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell
  • Recurrence

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Community Care PhysiciansAlbany, New York  12208