NCT00588913

Brief Summary

RATIONALE: Cellular adoptive immunotherapy uses a person's white blood cells that are treated in the laboratory to stimulate the immune system in different ways and stop tumor cells from growing. Aldesleukin may help the laboratory-treated white blood cells stay in the body longer. Drugs used in chemotherapy, such as zoledronic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cellular adoptive immunotherapy together with interleukin-2 and zoledronic acid may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects of giving cellular adoptive immunotherapy together with aldesleukin and zoledronic acid and to see how well it works in treating patients with stage IV kidney cancer and lung metastases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2006

Typical duration for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 9, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

July 10, 2013

Status Verified

August 1, 2009

Enrollment Period

3.2 years

First QC Date

December 20, 2007

Last Update Submit

July 9, 2013

Conditions

Kidney CancerMetastatic Cancer

Keywords

recurrent renal cell cancerstage IV renal cell cancerclear cell renal cell carcinomalung metastases

Outcome Measures

Primary Outcomes (2)

  • Frequency and severity of adverse events based on NCI-CTCAE version 3.0

  • Proportion of gd T-cells in peripheral blood

Secondary Outcomes (2)

  • Secondary doubling time of tumor growth

  • Overall response

Interventions

aldesleukinBIOLOGICAL
therapeutic autologous lymphocytesBIOLOGICAL
zoledronic acidDRUG

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed renal carcinoma * Stage IV disease with lung metastases * Bidimensionally measurable lung metastases by CT scan * Meets 1 or more of the following criteria: * No change in disease status or progressive disease after prior aldesleukin administration for 3 months or more * Lung metastases after treatment with prior nephrectomy * Patients with clear cell renal carcinoma must have undergone nephrectomy prior to study entry * Patients with progression of metastatic lung cancer after nephrectomy also must have received interferon alfa for 3 months or more (prior to study entry) PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy \> 6 months * Leukocyte count ≥ 3,000/mm³ * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Serum bilirubin ≤ 1.5 mg/dL * AST/ALT ≤ 2.5 times normal * Serum creatinine ≤ 1.7 mg/dL * LDH ≤ 1.5 times normal * Not pregnant nor nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infection with hepatitis virus or HIV * No poorly controlled heart failure or arrhythmia * No hypercalcemia that require medication * No C-reactive protein with an infectious disease that requires medication PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 3 weeks since prior chemotherapy, radiation therapy, or biologic therapy * No prior bone marrow transplantation or organ transplantation * No concurrent steroid therapy * No concurrent antidepressant therapy

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

Sponsors & Collaborators

Study Sites (2)

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

Location

Tokyo Women's Medical University

Tokyo, Tokyo, 162-8666, Japan

Location

MeSH Terms

Conditions

Kidney NeoplasmsNeoplasm MetastasisCarcinoma, Renal Cell

Interventions

aldesleukinZoledronic Acid

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Hirohito Kobayashi

    Tokyo Women's Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2007

First Posted

January 9, 2008

Study Start

January 1, 2006

Primary Completion

March 1, 2009

Study Completion

August 1, 2009

Last Updated

July 10, 2013

Record last verified: 2009-08

Locations

JP(2)