Know Cancer

forgot password

Treatment of Metastatic Renal Cell Carcinoma and Melanoma With Subsequential High-Dose Subcutaneous Interferon Alfa-2b and High-Dose Bolus and Continuous Intravenous Interleukin-2

Phase 2
18 Years
Not Enrolling
Kidney Cancer, Melanoma (Skin)

Thank you

Trial Information

Treatment of Metastatic Renal Cell Carcinoma and Melanoma With Subsequential High-Dose Subcutaneous Interferon Alfa-2b and High-Dose Bolus and Continuous Intravenous Interleukin-2

OBJECTIVES: I. Determine the safety, efficacy, and antitumor activity of high dose
interferon alfa-2b and interleukin-2 in patients with metastatic renal cell carcinoma or
melanoma. II. Determine the toxic effects of interferon alfa-2b and interleukin-2 in these

OUTLINE: This is an open label study. Patients receive subcutaneous interferon alfa-2b on
days 1-4. Patients are hospitalized and receive bolus infusions of interleukin-2 (IL-2)
followed by a continuous infusion on days 5-7. Patients are observed at least 12 hours
following IL-2 treatment. Treatment is repeated every 4 weeks until disease progression or
up to a maximum of six cycles. Patients are followed every 2 months for one year, then for

PROJECTED ACCRUAL: If at least 1 response is seen in the first 14 patients in each group, a
maximum of 40 patients per group will be accrued.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven metastatic renal cell carcinoma or melanoma
Measurable or evaluable disease No active brain metastases Previously treated CNS
metastases responding to therapy are eligible, but CNS cannot be the site of evaluable

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: ECOG 0-2 Life Expectancy:
Not specified Hematopoietic: Hematocrit at least 25 WBC at least 3,000/mm3 Platelet count
at least 100,000/mm3 PT and PTT within normal limits Hepatic: Bilirubin less than 2.0
mg/dL Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No myocardial infarction
within 6 months No medication for congestive heart failure or cardiac arrhythmias No
hypertension (unless blood pressure is stable off medication) Pulmonary: Must have
reasonable respiratory reserves and not require supplemental oxygen No dyspnea at rest
Oxygen saturation must be greater than 90% for patients with risk of respiratory symptoms
Other: Not HIV positive Not positive for hepatitis B antigen No chronic underlying
immunodeficiency No concurrent active infection requiring antibiotic therapy Not pregnant
or nursing No concurrent serious illness No family history of malignant hyperthermia No
hypersensitivity to interferon alfa-2b and interleukin-2

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior interleukin-2 and interferon alfa-2b
in combination therapy Chemotherapy: No prior systemic chemotherapy within 4 weeks of
study and recovered Endocrine therapy: No concurrent corticosteroid therapy Radiotherapy:
No prior radiotherapy within 4 weeks of interleukin-2 therapy No prior stereotactic
radiosurgery or gamma knife therapy within 1 week of interleukin-2 therapy Surgery: No
prior organ allograft transplantation Must be recovered from prior surgery Other: No
concurrent cyclosporin therapy No concurrent treatment with other anticancer agents

Type of Study:


Study Design:

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

Principal Investigator

Robert O. Dillman, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Biotherapy Research Group


United States: Federal Government

Study ID:




Start Date:

January 1996

Completion Date:

January 2000

Related Keywords:

  • Kidney Cancer
  • Melanoma (Skin)
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • stage IV melanoma
  • recurrent melanoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Melanoma



Hoag Memorial Hospital Presbyterian Newport Beach, California  92658
Bloomington Hospital Bloomington, Indiana  47402
Baptist Regional Cancer Center - Knoxville Knoxville, Tennessee  37901
St. Joseph Regional Cancer Center Bryan, Texas  77802