Interleukin-2 in Treating Patients With Metastatic or Recurrent Kidney Cancer

NCT00002846 | Unknown Phase 2

• 3 other identifiers: CDR0000065085CMC-09-95-15BNCI-V96-1038
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells. PURPOSE: Phase II trial to study the effectiveness of low-dose interleukin-2 in treating patients with metastatic or recurrent kidney cancer.

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancer; recurrent renal cell cancer

Interventions

aldesleukin 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 confirmed renal cell carcinoma (RCC) that is metastatic or recurrent * No central nervous system or major nerve involvement * No more than 25% estimated hepatic replacement by tumor on CT or MRI * Measurable disease required PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 80%-100% Life expectancy: * Greater than 3 months Hematopoietic: * Platelet count at least 80,000/mm3 Hepatic: * Bilirubin normal * AST and ALT no greater than 3 times normal Renal: * Creatinine normal Cardiovascular: * Stress cardiac exam normal (exam performed in patients aged 50 and older and in those with potential cardiac disease suggested by history, physical exam, or EKG) Pulmonary: * FEV1 and VC greater than 65% of predicted (tests performed in patients with significant smoking history and in those with potential pulmonary disease suggested by history, physical exam, or x-ray) Other: * No sites of ongoing bleeding * No HIV antibody or AIDS * No hepatitis B antigen * No systemic infection * No requirement for steroids * No psychiatric disease that precludes informed consent or safe administration of immunotherapy * No second malignancy except: * Basal cell carcinoma * In situ cervical cancer * Other cancer provided all evaluable lesions are documented RCC * No pregnant or nursing women * Effective contraception required of fertile women PRIOR CONCURRENT THERAPY: Biologic therapy * No prior interleukin-2 therapy Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * At least 28 days since therapy for RCC

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)

Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

aldesleukin

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

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)