Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Closed	under 75		CNR-9505 EU-95023

Objectives

I.  Determine the degree and duration of immune response following active 
specific immunotherapy with autologous tumor cells and BCG plus 
cyclophosphamide and low-dose interleukin-2 in patients with previously 
resected stage II/III renal cell adenocarcinoma.

II.  Assess the recurrence and survival rates following this treatment.

Entry Criteria

Disease Characteristics:

Histologically diagnosed renal cell adenocarcinoma
  No contralateral synchronous or metachronous disease

Pathologic stage II (pT2 N0 M0) or stage III (pT3a-b N0 M0 or pT1-3 N1 M0)
disease

Prior radical nephrectomy with no evidence of residual tumor required

Prior/Concurrent Therapy:

Biological therapy:
  No prior biological response modifier therapy

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  No prior hormonal therapy

Radiotherapy:
  No prior radiotherapy to the primary tumor

Surgery:
  See Disease Characteristics
  At least 28 days since surgery and recovered

Patient Characteristics:

Age:
  Under 75

Performance status:
  Karnofsky 50%-100%

Other:
  No major organ dysfunction that precludes protocol treatment
  No prior or concurrent malignancy

Expected Enrollment

A total of 100 patients will be accrued over 3 years.

Outline

Randomized study.  The following acronyms are used:
  ATC     Autologous Tumor Cells
  BCG     Bacillus Calmette-Guerin (strain unspecified)
  CTX     Cyclophosphamide, NSC-26271
  IL-2    Interleukin-2 (Chiron), NSC-373364

Arm I:  Adoptive Immunotherapy with Immunostimulation.  Irradiated ATC/BCG 
vaccine; with CTX; IL-2.

Arm II:  Control.  Observation only.

Trial Contact Information

Trial Lead Organizations

European Institute of Oncology

Enzo Galligioni, MD, Protocol chair		Ph: 39-04-61-902-478 Email: enzo.galligioni@apss.tn.it