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A Phase II Trial of Interferon Alpha-1b (IFN Alpha-1b) in Patients With Metastatic Clear Cell Renal Carcinoma

Phase 2
18 Years
Not Enrolling
Kidney Cancer

Thank you

Trial Information

A Phase II Trial of Interferon Alpha-1b (IFN Alpha-1b) in Patients With Metastatic Clear Cell Renal Carcinoma



- Determine the objective response rate in patients with metastatic renal clear cell
carcinoma treated with interferon alfa-1b.


- Determine the toxicity of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive interferon alfa-1b subcutaneously daily. Treatment continues in the absence
of unacceptable toxicity or disease progression.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed predominantly renal clear cell carcinoma

- Clinical evidence of OR biopsy-proven metastatic disease to a site or sites
distant from the primary tumor

- Must have measurable disease, defined as ≥ 1 unidimensionally measurable lesion
measured as ≥ 20 mm with conventional techniques OR as ≥ 10 mm with spiral CT scan

- Good- or intermediate-risk category as defined by having ≤ 2 of the following

- Time from initial diagnosis to treatment < 1 year

- Karnofsky performance status < 80%

- Hemoglobin < lower limit of normal

- Corrected calcium > 10.0 mg/dL

- Lactate dehydrogenase (LDH) > 1.5 times upper limit of normal (ULN)

- No major clinical ascites or pleural effusion

- No CNS metastases by neurologic exam and CT scan or MRI


- ECOG performance status 0-1

- Life expectancy ≥ 3 months

- WBC ≥ 3,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9.5 g/dL

- Creatinine ≤ 1.5 mg/dL (2.0 mg/dL in post-nephrectomy patients)

- Calcium normal

- Total bilirubin ≤ 1.5 mg/dL

- AST ≤ 3.0 times normal

- Alkaline phosphatase ≤ 2.5 times normal (10 times ULN in presence of bone metastases)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception prior to and for the duration of
study treatment

- No history of serious cardiac arrhythmia, congestive heart failure, angina pectoris,
or other severe cardiovascular disease (i.e., New York Heart Association class III or

- No known positivity for HIV or hepatitis B surface antigen

- No history of seizure disorders

- No local and/or systemic infections requiring antibiotics within 28 days prior to
study entry

- No other malignancy except basal cell or squamous cell carcinoma of the skin,
carcinoma in situ of the uterine cervix, or any malignancy treated with curative
intent and in complete remission for > 3 years


- No prior organ allografts

- No prior interferon

- No prior cytokine-based therapy for metastatic disease

- Prior radiotherapy is allowed for the control of pain from skeletal lesions provided
treatment was completed > 28 days prior to study entry and patient has recovered

- No major surgery requiring general anesthesia within 28 days prior to study entry

- No more than 2 prior therapies for metastatic disease

- No concurrent palliative radiotherapy

- No concurrent chemotherapy

- No concurrent hormonal therapy except for hormones administered for
nondisease-related conditions (e.g., insulin for diabetes)

- No concurrent steroid use except ongoing replacement therapy with physiologic doses
of corticosteroids

- No concurrent dexamethasone or other steroidal anti-emetics or

- No other concurrent anticancer therapy

- No concurrent aspirin or barbiturates

- No other concurrent investigational agents

Type of Study:


Study Design:

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

Outcome Measure:


Safety Issue:


Principal Investigator

Ronald M. Bukowski, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

February 2005

Completion Date:

April 2007

Related Keywords:

  • Kidney Cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • clear cell renal cell carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Cleveland, Ohio  44195