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Phase III Randomized Trial of Interferon-Alfa2b Alone Versus Interferon-Alfa2b Plus Thalidomide in Patients With Previously Untreated Metastatic or Unresectable Renal Cell Carcinoma

Phase 3
18 Years
Not Enrolling
Kidney Cancer

Thank you

Trial Information

Phase III Randomized Trial of Interferon-Alfa2b Alone Versus Interferon-Alfa2b Plus Thalidomide in Patients With Previously Untreated Metastatic or Unresectable Renal Cell Carcinoma


- Compare the overall and progression-free survival at 24 weeks in patients with
previously untreated metastatic or unresectable renal cell carcinoma treated with
interferon alfa-2b with or without thalidomide.

- Compare the safety of these 2 regimens in these patients.

- Compare the quality of life of patients treated with these 2 regimens.

- Compare the pharmacodynamic effects of these regimens on pharmacodynamic measurements
of angiogenesis such as serum and plasma angiogenic factor levels in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
nephrectomy (yes vs no), disease-free interval (no more than 1 year vs more than 1 year),
and ECOG performance status (0 vs 1 or 2). Patients are randomized to one of two treatment

- Arm I: Patients receive interferon alfa-2b subcutaneously (SC) twice daily beginning on
day 1.

- Arm II: Patients receive interferon alfa-2b as in arm I and oral thalidomide once daily
beginning on day 1.

Treatment in both arms continues in the absence of disease progression or unacceptable
toxicity. Patients who achieve complete response (CR) continue treatment for 24 weeks past

Quality of life is assessed prior to randomization and then every 4 weeks through week 24.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 346 patients (173 per arm) will be accrued for this study
within 2 years.

Inclusion Criteria


- Histologically proven previously untreated metastatic or unresectable renal cell

- Retroperitoneal lymph nodes that are unresectable or those that are not resected
at the investigator's discretion are considered metastatic disease

- Prior nephrectomy allowed provided there is evidence of unresponsive metastatic
disease after surgery or within one month prior to study enrollment

- Bidimensionally measurable disease

- Measurable disease must be outside any prior radiotherapy port

- No history of brain metastases unless surgically resected or treated with gamma knife
radiotherapy and currently without radiologic evidence of CNS disease



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified


- Absolute neutrophil count at least 1,500/mm^3

- Hemoglobin at least 9 g/dL (transfusion allowed)

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.5 mg/dL

- SGOT no greater than 3 times upper limit of normal


- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 60 mL/min


- No myocardial infarction within the past 6 months


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 2 effective methods of contraception (1 highly active
method and 1 barrier method) for at least 4 weeks before, during, and for at least 4
weeks after study participation

- No other malignancy within the past 5 years except curatively treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

- No uncontrolled diabetes or any other concurrent illnesses that would increase risk

- No history of peripheral neuropathy

- No severe depression


Biologic therapy:

- No prior immunotherapy (including adjuvant interferon alfa therapy), cellular
therapy, or vaccine therapy for renal cell carcinoma

- No prior antiangiogenesis therapy for renal cell carcinoma

- Immunotherapy for prior malignancy allowed (except for interferon alfa therapy)


- No prior chemotherapy for renal cell carcinoma

- Chemotherapy for prior malignancy allowed

Endocrine therapy:

- No prior hormonal therapy for renal cell carcinoma


- See Disease Characteristics

- At least 2 weeks since prior radiotherapy and recovered


- See Disease Characteristics


- More than 7 days since prior IV antibiotics for infection

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Michael S. Gordon, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea


United States: Federal Government

Study ID:




Start Date:

October 2000

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



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