High-Dose Interferon Alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer or Melanoma

Phase 2

Completed

• Conditions: Kidney Cancer; Melanoma (Skin)

• Registration Number: NCT00003091
• Lead Sponsor: Hoag Memorial Hospital Presbyterian

Brief Summary

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer or melanoma cells.

PURPOSE: Phase II trial to study the effectiveness of high-dose interferon alfa and interleukin-2 in treating patients with metastatic kidney cancer or melanoma.

Detailed Description

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 patients.

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 survival.

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.

Study Timeline

• Study Start: 1996-01
• Study First Submitted: 1999-11-01
• Primary Completion: 2000-01
• Study Completion: 2000-01
• Study First Submitted QC: 2004-07-06
• Study First Posted: 2004-07-07
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-10
• Last Update Posted: 2011-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (4)

Hoag Memorial Hospital Presbyterian; 🇺🇸 Newport Beach, California, United States

Bloomington Hospital; 🇺🇸 Bloomington, Indiana, United States

Baptist Regional Cancer Center - Knoxville; 🇺🇸 Knoxville, Tennessee, United States

St. Joseph Regional Cancer Center; 🇺🇸 Bryan, Texas, United States