Know Cancer

or
forgot password

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
N/A
Open (Enrolling)
Both
Kidney Cancer

Thank you

Trial Information

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


OBJECTIVES:

- 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
regimen.

- 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


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

Age:

- 16 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 4 months

Hematopoietic:

- Hematocrit greater than 25%

- Platelet count greater than 100,000/mm3

- No ongoing transfusion requirements

- No active blood clotting or bleeding diathesis

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

- Albumin at least 3.0 g/dL

- No significant hepatic dysfunction

Renal:

- Creatinine no greater than 2.0 mg/dL

- No significant renal dysfunction

Cardiovascular:

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

- No unstable angina related to atherosclerotic cardiovascular disease

Other:

- 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

PRIOR CONCURRENT THERAPY:

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%

Chemotherapy:

- At least 3 weeks since prior chemotherapy and recovered

- No concurrent chemotherapy

Endocrine therapy:

- See Disease Characteristics

- No concurrent corticosteroids

Radiotherapy:

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

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

- Recovered from prior surgery

Other:

- 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:

Interventional

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:

No

Principal Investigator

Robert O. Dillman, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Hoag Memorial Hospital Presbyterian

Authority:

United States: Federal Government

Study ID:

CDR0000068493

NCT ID:

NCT00014131

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

Name

Location

Hoag Cancer Center at Hoag Memorial Hospital PresbyterianNewport Beach, California  92663