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A Phase II Pilot Study of Tumor-Loaded Dendritic Cells Alone or Following a Non-Myeloablative Conditioning Regimen in Patients With Metastatic Renal Cell Carcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Kidney Cancer

Thank you

Trial Information

A Phase II Pilot Study of Tumor-Loaded Dendritic Cells Alone or Following a Non-Myeloablative Conditioning Regimen in Patients With Metastatic Renal Cell Carcinoma


OBJECTIVES:

Primary

- Compare the safety of vaccination comprising autologous dendritic cells loaded with
autologous tumor lysate and keyhole limpet hemocyanin with vs without non-myeloablative
fludarabine in patients with stage IV renal cell carcinoma.

- Compare, preliminarily, the efficacy of these regimens in these patients.

- Compare the overall survival of patients treated with these regimens.

Secondary

- Determine whether this vaccine induces tumor-reactive peripheral T-cell responses or
delayed-type hypersensitivity in these patients.

OUTLINE: This is a pilot, randomized study. Patients are randomized to 1 of 2 treatment
arms.

All patients undergo surgery to remove tumor at metastatic sites to generate autologous
tumor lysate. Patients then undergo leukapheresis to obtain peripheral blood mononuclear
cells for the generation of dendritic cells (DC). The DC are then exposed to autologous
tumor lysate and keyhole limpet hemocyanin (KLH).

- Arm I: Three weeks after leukapheresis, patients receive vaccination comprising DC
loaded with autologous tumor lysate and KLH (DC vaccine) intradermally once every 14
days for a total of 4 injections in the absence of disease progression or unacceptable
toxicity.

- Arm II: Two weeks after leukapheresis, patients receive fludarabine IV over 15-30
minutes once daily for 3 days. Beginning approximately 5 weeks after leukapheresis,
patients also receive DC vaccine as in arm I.

Patients are followed at 1, 3, and 7-9 weeks, at 4, 6, 9, and 12 months, and then every 6
months for 2 years.

PROJECTED ACCRUAL: A total of 28 patients (14 per treatment arm) will be accrued for this
study within 2-3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed renal cell carcinoma

- Stage IV disease

- Received no benefit from standard therapy OR ineligible for standard therapy OR
declined standard therapy

- At least 1 site of metastatic disease that can be surgically removed AND at least 1
site of metastatic disease than can remain in the patient (indicator lesion) after
surgery

- Total volume of the site or sites of disease to be surgically removed must be >
2.0 cm^3

- Unidimensionally measurable disease

- At least 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

- No brain metastasis

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- More than 6 months

Hematopoietic

- WBC ≥ 3,000/mm^3

- Platelet count ≥ 75,000/mm^3

- Hemoglobin ≥ 10 g/dL

Hepatic

- SGPT and SGOT ≤ 2.5 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN

- Hepatitis C antibody negative

- Hepatitis B surface antigen negative

Renal

- Creatinine ≤ 1.5 times ULN

- Creatinine clearance > 40 mL/min

Cardiovascular

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

Immunologic

- Coomb's test negative

- HIV-1 and -2 negative

- No active infection

- No unexplained fever (temperature > 100.5° F or 38.1°C)

- No lymphocytopenia

- No hypogammaglobulinemia

- No autoimmune disease or other immunocompromising condition that would preclude study
participation

- No history of impaired immune response

- No history of tuberculosis OR positive PPD skin test

- No history of allergic reaction attributed to compounds of similar biological
composition to study vaccine

- No history of allergic reaction to antibiotics

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 1 month after study
participation

- No psychiatric illness or social situation that would preclude study participation

- No other malignancy within the past 5 years except resected basal cell carcinoma or
carcinoma in situ of the cervix

- No other concurrent illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 4 weeks since prior immunotherapy

Chemotherapy

- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

- At least 4 weeks since prior steroid therapy or steroid-containing compounds

- At least 2 weeks since prior topical or inhaled steroids

Radiotherapy

- More than 4 weeks since prior radiotherapy

Surgery

- See Disease Characteristics

Other

- More than 4 weeks since prior investigational agents

- More than 1 week since prior antibiotics

- No concurrent renal dialysis

- No concurrent anticoagulants

- No other concurrent anticancer agents or therapies

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Safety as measured by NCI common toxicity table at completion of study

Safety Issue:

Yes

Principal Investigator

John P. Hanson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Luke's Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000389145

NCT ID:

NCT00093522

Start Date:

August 2004

Completion Date:

Related Keywords:

  • Kidney Cancer
  • recurrent renal cell cancer
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical CenterMilwaukee, Wisconsin  53201-2901
Midwest Heart Surgery Institute, LimitedMilwaukee, Wisconsin  53215