Adoptive Immunotherapy, Aldesleukin, and Zoledronate in Treating Patients With Stage IV Kidney Cancer and Lung Metastases

Phase 1

Completed

• Conditions: Kidney Cancer; Metastatic Cancer

• Registration Number: NCT00588913
• Lead Sponsor: Tokyo Women's Medical University

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.

Detailed Description

OBJECTIVES:

* Determine the safety of adoptive immunotherapy comprising 2-methyl-3-butenyl-1-pyrophosphate-stimulated gamma delta (gd) T cells, zoledronate, and IL-2 after nephrectomy, especially with regard to the incidence and frequency of adverse events.

* Determine the duration of in vivo persistence of the transferred gd T cells in patients.

* Determine the doubling time of tumor growth before and after adoptive immunotherapy.

* Determine the tumor-size reducing effect of adoptive immunotherapy based on the Best Overall Response Chart.

OUTLINE: Patients undergo leukapheresis for the harvest of peripheral blood mononuclear cells (PBMCs). PBMCs are stimulated with 2-methyl-3-butenyl-1-pyrophosphate and aldesleukin for 11 days. Patients then receive the expanded Gamma Delta T cells, aldesleukin, and zoledronic acid once a month for 6 months.

After completion of study treatment, patients are followed for up to 1 month.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-28
• Study First Posted: 2008-01-09
• Primary Completion: 2009-03
• Status Verified: 2009-08
• Study Completion: 2009-08
• Last Update Submitted: 2013-07-09
• Last Update Posted: 2013-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency and severity of adverse events based on NCI-CTCAE version 3.0
Proportion of gd T-cells in peripheral blood

Secondary Outcome Measures

Name	Time	Method
Secondary doubling time of tumor growth
Overall response

Trial Locations

Locations (2)

Kyoto University Hospital; 🇯🇵 Kyoto, Japan

Tokyo Women's Medical University; 🇯🇵 Tokyo, Japan