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AzTrials

Kidney CancerPhase 1/2NCT00588913

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

A Phase 1/2 study testing aldesleukin, therapeutic autologous lymphocytes and zoledronic acid in people with Kidney Cancer and Metastatic Cancer, run by Tokyo Women's Medical University at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Kidney Cancer, Metastatic Cancer
What is being tested?
aldesleukin, therapeutic autologous lymphocytes and zoledronic acid
How many people
20 participants
Where
2 sitesJapan
Study dates
Jan 2006to Aug 2009
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • Kyoto University Hospital

    Kyoto, Kyoto, 606-8507

  • Tokyo Women's Medical University

    Tokyo, Tokyo, 162-8666

Other trials in Japan

About this study

Official title: Phase I/II Study of Adoptive Immunotherapy Comprising Pyrophosphomonoester Antigen-stimulated T Cells, IL-2, and Nitrogen-containing Bisphosphonates in Patients With Stage IV Renal Cell Carcinoma

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.

Read the 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.

Being tested
aldesleukin, therapeutic autologous lymphocytes, zoledronic acid
Keywords
recurrent renal cell cancer, stage IV renal cell cancer, clear cell renal cell carcinoma, lung metastases
Medical subject headings
Kidney Neoplasms, Neoplasm Metastasis, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

  2. Proportion of gd T-cells in peripheral blood

Secondary outcomes (2)

  1. Secondary doubling time of tumor growth

  2. Overall response

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2008 (estimated)
  2. Study startJan 2006
  3. Primary completionMar 2009
  4. Study completionAug 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00588913
Sponsor's protocol ID
TRIC-CTR-GU-05-01
Other IDs
CDR0000581156
Status last verified
Aug 2009
First submitted
20 Dec 2007
Last updated
10 Jul 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing aldesleukin, therapeutic autologous lymphocytes and zoledronic acid in people with Kidney Cancer and Metastatic Cancer, run by Tokyo Women's Medical University at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and severity of adverse events based on NCI-CTCAE version 3.0. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00588913.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2013.

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