NCT00006864

Brief Summary

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells. PURPOSE: Phase IV trial to study the effectiveness of interleukin-2 in treating patients who have metastatic kidney cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jul 2000

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2000

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

June 2, 2003

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

January 9, 2014

Status Verified

January 1, 2014

Enrollment Period

7 years

First QC Date

December 6, 2000

Last Update Submit

January 8, 2014

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancerrecurrent renal cell cancerclear cell renal cell carcinoma

Interventions

aldesleukinBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven metastatic renal cell carcinoma * Clear cell * Papillary * Sarcomatoid * Mixed * Measurable or evaluable disease * Evidence of disease following surgical resection of metastases * No CNS disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Hemoglobin at least 10 g/dL * WBC at least 4,000/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Not specified Renal: * Creatinine no greater than 1.8 mg/dL Cardiovascular: * No New York Heart Association class III or IV heart disease Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception (barrier plus 1 other method) * Thyroid-stimulating hormone normal * No known hypersensitivity or allergy to components of recombinant human interleukin-2 * No known autoimmune disease (e.g., Crohn's disease) * No other concurrent medical condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior recombinant human interleukin-2 * No concurrent interferon alfa Chemotherapy: * No concurrent cytoxic chemotherapy Endocrine therapy: * No concurrent hormonal therapy (e.g., medroxyprogesterone) other than estrogen replacement therapy * No concurrent prophylactic glucocorticoids (replacement doses and topical use allowed) * No concurrent systemic corticosteroids Radiotherapy: * At least 4 weeks since prior radiotherapy * No prior radiotherapy to index lesion * No concurrent radiotherapy Surgery: * See Disease Characteristics * Prior surgery for renal cell carcinoma allowed Other: * No prior systemic therapy for renal cell carcinoma * At least 4 weeks since prior investigational drugs * No other concurrent investigational drugs or participation in another clinical study * No concurrent iodinated radiocontrast dye * No concurrent drugs for another indication that has purported activity in treatment of neoplasia (e.g., thalidomide)

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

Sponsors & Collaborators

Study Sites (2)

Northwestern Connecticut Oncology-Hematology Associates

Torrington, Connecticut, 06790, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, 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

  • Cindy Connell, MD, PhD

    University Hospitals Seidman Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2000

First Posted

June 2, 2003

Study Start

July 1, 2000

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

January 9, 2014

Record last verified: 2014-01

Locations

US(2)