Vaccine Therapy in Treating Patients With Kidney Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
NeoStem, Inc.
ClinicalTrials.gov Identifier:
NCT00014131
First received: April 10, 2001
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have recurrent or stage III or stage IV kidney cancer.


Condition Intervention Phase
Kidney Cancer
Biological: Biological/Vaccine: therapeutic autologous dendritic cells.
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vaccine Biotherapy Of Cancer: Autologous Tumor Cells And Dendritic Cells As Active Specific Immunotherapy In Patients With Stage IV Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by NeoStem, Inc.:

Primary Outcome Measures:
  • Conversion of the delayed-type hypersensitivity (DTH) skin test as measured by metric skin ruler at week 4 and month 6 during vaccine therapy [ Time Frame: week 4 and month 6 during vaccine therapy ] [ Designated as safety issue: No ]
  • Tumor response (partial response or complete response) as measured by RECIST at months 2 or 3 and 6 during study treatment, and 6 months after study completion [ Time Frame: months 2 or 3 and 6 during study treatment, and 6 months after study completion ] [ Designated as safety issue: No ]
  • Progression-free survival as measured by RECIST at months 2 or 3 and 6 during study treatment and every 6 months after study completion [ Time Frame: months 2 or 3 and 6 during study treatment and every 6 months after study completion ] [ Designated as safety issue: No ]
  • Event-free survival as measured by RECIST at months 2 or 3 and 6 during study treatment and every 6 months after study completion [ Time Frame: months 2 or 3 and 6 during study treatment and every 6 months after study completion ] [ Designated as safety issue: No ]
  • Overall survival beginning at the date of study entry [ Time Frame: 5 years or until death, whichever came first. ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: November 2001
Estimated Study Completion Date: December 2015
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biological/Vaccine
Biological/Vaccine: therapeutic autologous dendritic cells. Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product.
Biological: Biological/Vaccine: therapeutic autologous dendritic cells.
Biological/Vaccine: therapeutic autologous dendritic cells. Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00014131

Locations
United States, California
Hoag Cancer Center at Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Sponsors and Collaborators
NeoStem, Inc.
Investigators
Study Chair: Robert O. Dillman, MD, FACP Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian
  More Information

No publications provided

Responsible Party: NeoStem, Inc.
ClinicalTrials.gov Identifier: NCT00014131     History of Changes
Other Study ID Numbers: CDR0000068493, HOAG-VACCINE-RN, NCI-V01-1647
Study First Received: April 10, 2001
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by NeoStem, Inc.:
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 14, 2014