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

Primary Purpose

Kidney Cancer, Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
recombinant interferon alfa
Sponsored by
Hoag Memorial Hospital Presbyterian
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer, recurrent renal cell cancer, stage IV melanoma, recurrent melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 disease 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

Sites / Locations

  • Hoag Memorial Hospital Presbyterian
  • Bloomington Hospital
  • Baptist Regional Cancer Center - Knoxville
  • St. Joseph Regional Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
May 10, 2011
Sponsor
Hoag Memorial Hospital Presbyterian
Collaborators
Cancer Biotherapy Research Group
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1. Study Identification

Unique Protocol Identification Number
NCT00003091
Brief Title
High-Dose Interferon Alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer or Melanoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
January 1996 (undefined)
Primary Completion Date
January 2000 (Actual)
Study Completion Date
January 2000 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hoag Memorial Hospital Presbyterian
Collaborators
Cancer Biotherapy Research Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer, Melanoma (Skin)
Keywords
stage IV renal cell cancer, recurrent renal cell cancer, stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 disease 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert O. Dillman, MD, FACP
Organizational Affiliation
Cancer Biotherapy Research Group
Official's Role
Study Chair
Facility Information:
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Facility Name
Bloomington Hospital
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47402
Country
United States
Facility Name
Baptist Regional Cancer Center - Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37901
Country
United States
Facility Name
St. Joseph Regional Cancer Center
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16706633
Citation
Dillman RO, Wiemann MC, Tai DF, Depriest CB, Soori G, Stark JJ, Mahdavi K, Church CK. Phase II trial of subcutaneous interferon followed by intravenous hybrid bolus/continuous infusion interleukin-2 in the treatment of renal cell carcinoma: final results of Cancer Biotherapy Research Group 95-09. Cancer Biother Radiopharm. 2006 Apr;21(2):130-7. doi: 10.1089/cbr.2006.21.130.
Results Reference
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High-Dose Interferon Alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer or Melanoma

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