NCT00057889

Brief Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have metastatic renal cell cancer (kidney cancer) that is refractory to treatment with interleukin-2 or unable to be treated with interleukin-2.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2003

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

March 15, 2012

Status Verified

March 1, 2012

Enrollment Period

4.7 years

First QC Date

April 7, 2003

Last Update Submit

March 14, 2012

Conditions

Kidney Cancer

Keywords

clear cell renal cell carcinomastage IV renal cell cancerrecurrent renal cell cancer

Interventions

ipilimumabBIOLOGICAL

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed stage IV clear cell renal carcinoma * At least 1 site of measurable disease * Meeting criteria for 1 of the following: * Disease progression after prior interleukin-2 (IL-2) * Ineligible for standard high-dose IV IL-2 due to comorbid medical conditions * Minimal disease (lesions ≤ 3 cm that do not pose risk to organ function) such that participation in this study is not likely to compromise the patient's opportunity to receive future high-dose IL-2 * Indolent disease (defined as an increase in tumor size of \< 50% within the past 6 months) such that participation in this study is not likely to compromise the patient's opportunity to receive future high-dose IL-2 * No true papillary, medullary, chromophobe, collecting duct, or oncocytic renal cancer PATIENT CHARACTERISTICS: Age * 16 and over Performance status * ECOG 0-1 Life expectancy * At least 3 months Hematopoietic * WBC ≥ 2,500/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL * Hematocrit ≥ 30% Hepatic * AST ≤ 3 times upper limit of normal (ULN) * Bilirubin ≤ ULN (\< 3.0 mg/dL for patients with Gilbert's syndrome) * Hepatitis B surface antigen negative * Hepatitis C antibody negative Renal * Creatinine \< 2.0 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No other malignancy except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or any other cancer from which the patient has been disease free for at least 5 years * No autoimmune disease (including uveitis and autoimmune inflammatory eye disease) * No active uncontrolled infection * No other medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody * At least 3 weeks since prior immunotherapy for renal cancer Chemotherapy * At least 3 weeks since prior chemotherapy for renal cancer * No concurrent chemotherapy Endocrine therapy * At least 3 weeks since prior hormonal therapy for renal cancer * More than 4 weeks since prior corticosteroids * No concurrent systemic or topical corticosteroids Radiotherapy * At least 3 weeks since prior radiotherapy for renal cancer Surgery * Not specified Other * Recovered from prior therapy * At least 3 weeks since other prior therapy for renal cancer * No concurrent immunosuppressive agents (e.g., cyclosporine and its analog)

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

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

Ipilimumab

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • James C. Yang, MD

    NCI - Surgery Branch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

April 7, 2003

First Posted

April 9, 2003

Study Start

February 1, 2003

Primary Completion

October 1, 2007

Study Completion

February 1, 2008

Last Updated

March 15, 2012

Record last verified: 2012-03

Locations

US(1)