Interferon Alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

NCT00002847 | Unknown Phase 2

• 3 other identifiers: CDR0000065086CMC-09-95-14BNCI-V96-1039
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Biological therapies use different ways to stimulate the immune system to try to stop cancer cells from growing. Combining interferon alfa and interleukin-2 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of interferon alfa and interleukin-2 in treating patients with metastatic kidney cancer.

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancer; recurrent renal cell cancer

Interventions

aldesleukin BIOLOGICAL

recombinant interferon alfa BIOLOGICAL

conventional surgery PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically proven renal cell cancer that is metastatic * No greater than 50% estimated hepatic replacement by tumor on CT or MRI * No symptomatic involvement of the CNS or a major nerve * Measurable disease required * Ineligible for treatment with low-dose interleukin-2 on another CMC protocol PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 50%-100% Life expectancy: * More than 3 months Hematopoietic: * No coagulopathy (i.e., platelet count less than 80,000/mm3) Hepatic: * AST and ALT no greater than 5 times normal Renal: * Creatinine less than 4.0 mg/dL Cardiovascular: * No symptomatic angina * No untreated coronary artery disease * No refractory arrhythmia * No abnormal left ventricular function Pulmonary: * No dyspnea on minimal exertion Other: * No site of ongoing bleeding * No systemic infection * No HIV antibody * No HBsAg * No requirement for steroids * No psychiatric disease that precludes informed consent or protocol treatment * No second malignancy except: * Basal cell skin carcinoma * Carcinoma in situ of the cervix * Not pregnant or nursing * Effective contraception required of fertile women PRIOR CONCURRENT THERAPY: Biologic therapy * No prior interleukin-2 Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * At least 28 days since prior treatment for renal cell cancer

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Blumenthal Cancer Center at Carolinas Medical Center: lead

Study Sites (1)

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

aldesleukin; Interferon-alpha

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Richard L. White, MD

  Blumenthal Cancer Center at Carolinas Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: September 1, 1995
• Last Updated: December 19, 2013

Record last verified: 2003-12

Locations

US (1)