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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


Phase 1/Phase 2
20 Years
80 Years
Not Enrolling
Both
Kidney Cancer, Metastatic Cancer

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

Yes

Principal Investigator

Hirohito Kobayashi

Investigator Role:

Study Chair

Investigator Affiliation:

Tokyo Women's Medical University

Authority:

United States: Federal Government

Study ID:

TRIC-CTR-GU-05-01

NCT ID:

NCT00588913

Start Date:

January 2006

Completion Date:

August 2009

Related Keywords:

  • Kidney Cancer
  • Metastatic Cancer
  • recurrent renal cell cancer
  • stage IV renal cell cancer
  • clear cell renal cell carcinoma
  • lung metastases
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

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