NCT00002589

Brief Summary

RATIONALE: Treating a person's lymphocytes with interleukin-2 and monoclonal antibody may help them kill more cancer cells when they are put back in the body. PURPOSE: This phase II trial is studying how well lymphocyte therapy works in treating patients with stage III or stage IV kidney cancer.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 1994

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

December 18, 2013

Status Verified

December 1, 2005

First QC Date

November 1, 1999

Last Update Submit

December 17, 2013

Conditions

Kidney Cancer

Keywords

stage III renal cell cancerstage IV renal cell cancerrecurrent renal cell cancer

Outcome Measures

Primary Outcomes (3)

  • Survival as measured by Kaplan-Meier method at 5 years

  • Onset of recurrence as measured by Kaplan-Meier method at 5 years

  • Safety as measured by NCI Common Toxicity Criteria at completion of study

Interventions

aldesleukinBIOLOGICAL
muromonab-CD3BIOLOGICAL
therapeutic autologous lymphocytesBIOLOGICAL
adjuvant therapyPROCEDURE

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically documented and completely resected stage III or stage IV renal cell carcinoma, clinically staged within 2 months prior to initiation of therapy * No evidence of nephrotic syndrome PATIENT CHARACTERISTICS: Age: * Over 16 Performance status: * ECOG 0-2 Hematopoietic: * WBC at least 3,000/mm\^3 * Granulocyte count at least 1,500/mm\^3 * Platelet count 50,000/mm3 to 500,000/mm\^3 * Hemoglobin at least 10 g/dL * No hematologic abnormalities Hepatic: * PT no greater than 1.5 times control * PTT less than 1.5 times control * Hepatitis B surface antigen negative Renal: * Creatinine no greater than 4.0 mg/dL * Calcium no greater than 12 mg/dL * No symptomatic hypercalcemia Cardiovascular: * No uncontrolled or severe cardiac disease, e.g.: * No myocardial infarction within 6 months * No congestive heart failure Other: * HIV negative * No significant organ dysfunction * No other serious medical illness that would limit life expectancy * No significant CNS disease including uncontrolled or untreated psychiatric or seizure disorders * No uncontrolled bacterial, viral, or fungal infection * No active peptic or duodenal ulcer * Adequate peripheral venous access required * No prior malignancy within past 5 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix * Not pregnant * Negative pregnancy test PRIOR CONCURRENT THERAPY: * No other concurrent postnephrectomy adjuvant therapy Biologic therapy: * No concurrent immunotherapy Chemotherapy: * No concurrent chemotherapy Endocrine therapy: * More than 1 week since prior corticosteroids (except as inhalation therapy for respiratory ailments or replacement for adrenal insufficiency) * No concurrent therapy with the following: * Estrogens (except as postmenopausal replacement therapy) * Androgens * Progestins * Antiestrogens * Antiandrogens * LHRH analogues or antagonists * Other hormones Radiotherapy: * Not specified Surgery: * See Disease Characteristics * No prior solid organ allograft * More than 3 weeks since major surgery, including nephrectomy

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

Sponsors & Collaborators

Study Sites (1)

Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53201-2901, United States

Location

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

aldesleukinMuromonab-CD3Chemotherapy, Adjuvant

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, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsImmunoglobulin GImmunoglobulin IsotypesSerum GlobulinsGlobulinsCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • John P. Hanson, MD

    St. Luke's Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

July 1, 1994

Last Updated

December 18, 2013

Record last verified: 2005-12

Locations

US(1)