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Vaccine Biotherapy Of Cancer: Autologous Tumor Cells And Dendritic Cells As Active Specific Immunotherapy In Patients With Stage IV Renal Cell Carcinoma

Phase 1/Phase 2
16 Years
Open (Enrolling)
Kidney Cancer

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Trial Information

Vaccine Biotherapy Of Cancer: Autologous Tumor Cells And Dendritic Cells As Active Specific Immunotherapy In Patients With Stage IV Renal Cell Carcinoma


- Determine the safety of immunization with in vitro-treated autologous tumor cells and
dendritic cells with sargramostim (GM-CSF) in patients with stage III or IV or
recurrent renal cell cancer.

- Determine the frequency of conversion of delayed tumor hypersensitivity tests in these
patients treated with this regimen.

- Determine the progression-free and overall survival of these patients treated with this

- Determine the objective tumor response rate in patients who still have measurable
disease at the time they are treated with this regimen.

OUTLINE: Patients are stratified according to measurable disease at the time vaccine therapy
is initiated (yes vs no).

Patients undergo tumor cell harvest. Patients with multiple persistent sites of metastatic
disease following harvest receive systemic therapy (biologic therapy and/or chemotherapy)
during tumor cell line expansion. Over 2-4 months, the tumor cell line is expanded, treated
with interferon gamma, and irradiated.

Patients undergo leukapheresis to obtain peripheral blood mononuclear cells (PBMC). The PBMC
are incubated over 7 days with sargramostim (GM-CSF) and interleukin-4 to produce dendritic
cells (DC). The DC are incubated over 2-3 days with the irradiated tumor cells from the
autologous tumor cell line for antigen loading of the DC.

Patients undergo delayed tumor hypersensitivity testing 1 week prior to vaccination and
again at week 4. Patients receive vaccine therapy comprising autologous treated tumor cells
and DC suspended in GM-CSF subcutaneously weekly for 3 weeks. Vaccine therapy continues
monthly for 5 months in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 1 year and then every 3 months for 4 years.

PROJECTED ACCRUAL: A total of 80 patients (40 per stratum) will be accrued for this study.

Inclusion Criteria


- Histologically confirmed renal cell carcinoma

- Stage III or IV disease involving invasions beyond Gerota's fascia, regional
lymph node involvement, or distant metastases OR

- Recurrent disease involving lymph node metastases or soft tissue nodules

- Measurable disease by anatomic-based radiological tests (unless no evidence of
disease as documented by prior surgery)

- Planned resection of tumor to establish an autologous tumor cell line

- No active CNS metastases such as brain metastases, spinal cord compression, or
leptomeningeal disease

- Prior brain metastases or spinal cord compression allowed provided there is
radiographic evidence of lack of progression and no requirement for
pharmacologic doses of corticosteroids



- 16 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 4 months


- Hematocrit greater than 25%

- Platelet count greater than 100,000/mm3

- No ongoing transfusion requirements

- No active blood clotting or bleeding diathesis


- Bilirubin no greater than 2.0 mg/dL

- Albumin at least 3.0 g/dL

- No significant hepatic dysfunction


- Creatinine no greater than 2.0 mg/dL

- No significant renal dysfunction


- No underlying cardiac disease associated with New York Heart Association class III or
IV heart function

- No unstable angina related to atherosclerotic cardiovascular disease


- No other malignancy within the past 5 years except carcinoma in situ, basal cell or
localized squamous cell skin cancer, or localized prostate cancer

- No active infection

- No other active medical condition that could be eminently life threatening

- Not pregnant

- Fertile patients must use effective contraception


Biologic therapy:

- Other prior putative vaccines allowed

- Recovered from prior biologic therapy

- No concurrent biologic therapy except epoetin alfa for patients with hematocrit less
than 36%


- At least 3 weeks since prior chemotherapy and recovered

- No concurrent chemotherapy

Endocrine therapy:

- See Disease Characteristics

- No concurrent corticosteroids


- At least 3 weeks since prior radiotherapy (including whole-brain radiotherapy) and

- No concurrent radiotherapy


- See Disease Characteristics

- Recovered from prior surgery


- Concurrent bisphosphonates allowed for patients with lytic bone metastases

- No concurrent digoxin or other medications designed to improve cardiac output

- No other concurrent anticancer therapy or investigational therapy

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Conversion of the delayed-type hypersensitivity (DTH) skin test as measured by metric skin ruler at week 4 and month 6 during vaccine therapy

Safety Issue:


Principal Investigator

Robert O. Dillman, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Hoag Memorial Hospital Presbyterian


United States: Federal Government

Study ID:




Start Date:

November 2001

Completion Date:

Related Keywords:

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



Hoag Cancer Center at Hoag Memorial Hospital Presbyterian Newport Beach, California  92663