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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
N/A
Not Enrolling
Both
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


OBJECTIVES:

- 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
arms.

- 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
CR.

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


DISEASE CHARACTERISTICS:

- Histologically proven previously untreated metastatic or unresectable renal cell
carcinoma

- 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

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- 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

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- SGOT no greater than 3 times upper limit of normal

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- No myocardial infarction within the past 6 months

Other:

- 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

PRIOR CONCURRENT THERAPY:

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)

Chemotherapy:

- No prior chemotherapy for renal cell carcinoma

- Chemotherapy for prior malignancy allowed

Endocrine therapy:

- No prior hormonal therapy for renal cell carcinoma

Radiotherapy:

- See Disease Characteristics

- At least 2 weeks since prior radiotherapy and recovered

Surgery:

- See Disease Characteristics

Other:

- More than 7 days since prior IV antibiotics for infection

Type of Study:

Interventional

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

Authority:

United States: Federal Government

Study ID:

CDR0000067949

NCT ID:

NCT00005966

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

Name

Location

Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Mercy Cancer Center at Mercy Medical Center-Des MoinesDes Moines, Iowa  50314
Midlands Cancer Center at Midlands Community HospitalPapillion, Nebraska  68128-4157
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, Arizona  85259
Comprehensive Cancer Center at Our Lady of Mercy Medical CenterBronx, New York  10466