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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 to 75 EORTC-30923

Objectives

I.  Assess the objective tumor response rate in patients with advanced renal 
cell carcinoma treated with roquinimex.

II.  Estimate time to disease progression and time to treatment failure of 
patients treated with this agent.

III.  Evaluate the toxicity of this therapy.

IV.  Study the plasma concentrations of roquinimex achieved with daily 
treatment.

V.  Study the effects of treatment on peripheral blood immunologic parameters.

Entry Criteria

Disease Characteristics:

Histologically proven renal cell adenocarcinoma that has
progressed within 2 months of entry
  Histological or cytological confirmation of any metastases
  required

  Prior nephrectomy required

Bidimensionally measurable disease required as defined by any
of the following:
  Lung metastasis greater than 2.0 cm in diameter
  Superficial lymph node greater than 2.5 cm in diameter
  Skin or subcutaneous metastasis greater than 2.5 cm in
     diameter
  Mediastinal or retroperitoneal lymph node metastases greater
     than 2.5 cm in diameter on CT scan

  New or progressive disease in previously irradiated tissue
  allowed

No brain metastases or other CNS lesions

No bone metastases

No liver metastases

Prior/Concurrent Therapy:

Biologic therapy:
  No prior immunotherapy for renal cell carcinoma
  No concomitant biologic response modifiers

Chemotherapy:
  No prior chemotherapy for renal cell carcinoma

Endocrine therapy:
  No prior hormonal therapy for renal cell carcinoma

Radiotherapy:
  Prior radiotherapy allowed
  At least 12 weeks since prior radiotherapy

Surgery:
  Prior nephrectomy required

Other:
  No concomitant treatment with any of the following:
     Corticosteroids
     H2 antagonists
     NSAIDs
     Acetylsalicylic or salicylic acid
     Cytostatic agents
     Ciprofloxacin

Patient Characteristics:

Age:
  18-75

Performance status:
  WHO 0 or 1

Hematopoietic:
  Not specified

Hepatic:
  Bilirubin less than 1.1 mg/dl (less than 20 micromoles/liter)

Renal:
  Creatinine less than 1.7 mg/dl (less than 150
  micromoles/liter)

Cardiovascular:
  No WHO class 3 or 4 CHF

Pulmonary:
  No severe asthma
  No chronic bronchitis

Other:
  No second malignancy except:
     Nonmelanomatous skin cancer
     Adequately treated in situ carcinoma of the cervix
  No pregnant or nursing women
  Adequate contraception required of fertile women

Expected Enrollment

Up to 40 patients will be entered over approximately 1 year.  If no responses 
are seen among the first 20 evaluable patients, the study will be terminated.

Outline

Nonrandomized study.

Biological Response Modifier Therapy.  Roquinimex.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Ronald De Wit, MD, PhD, Protocol chair		Ph: 31-10-439-1760 Email: r.dewit@erasmusmc.nl