NCT00080977

Brief Summary

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill renal cell carcinoma (kidney cancer) cells. PURPOSE: This phase II trial is studying how well high-dose intravenous interleukin-2 works in treating patients with metastatic renal cell carcinoma that has not responded to previous low-dose intravenous or subcutaneous interleukin-2.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1998

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2004

Completed
Last Updated

December 19, 2013

Status Verified

June 1, 2005

First QC Date

April 7, 2004

Last Update Submit

December 18, 2013

Conditions

Kidney Cancer

Keywords

recurrent renal cell cancerstage IV renal cell cancer

Interventions

aldesleukinBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma * Metastatic disease * No pure papillary or sarcomatoid variants * Measurable disease * Failed prior subcutaneous OR intravenous (dose ≤ 50,000 IU/kg/day) interleukin-2 * Documented disease progression * No estimated hepatic replacement by tumor \> 25% by CT scan or MRI * No tumor involving the CNS or a major nerve PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 80-100% Life expectancy * More than 3 months Hematopoietic * Platelet count ≥ 80,000/mm\^3 * No sites of ongoing bleeding Hepatic * See Disease Characteristics * Bilirubin ≤ 1.4 mg/dL * AST and ALT ≤ 3 times normal * PT or PTT INR ≤ 1.2 * Hepatitis B surface antigen negative * Hepatitis C virus negative * No coagulation disorders Renal * Creatinine ≤ 1.6 mg/dL Cardiovascular * No ongoing ischemia\* * No cardiac dysfunction\* * No abnormal ejection fraction\* NOTE: \*A cardiac stress test is indicated for all patients ≥ 50 years of age and for any patient with possible cardiac disease as suggested by history, physical exam, or electrocardiogram Pulmonary * FEV\_1 ≤ 65% of predicted\* * Vital capacity ≤ 65% of predicted\* NOTE: \*Pulmonary function tests are to be performed on any patient with a significant smoking history or suspected pulmonary disease either by history, physical exam, or radiograph Other * HIV negative * No AIDS * No systemic infections * No other malignancy except carcinoma in situ * No psychiatric illness that would preclude study participation or compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * Not specified Endocrine therapy * No concurrent steroids Radiotherapy * Not specified Surgery * Not specified Other * More than 28 days since other prior treatment for renal cell cancer * No concurrent immunosuppressive agents

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

Sponsors & Collaborators

Study Sites (1)

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms 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

April 7, 2004

First Posted

April 8, 2004

Study Start

June 1, 1998

Last Updated

December 19, 2013

Record last verified: 2005-06

Locations

US(1)