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Vaccine Therapy in Treating Patients With Kidney Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00014131
Recruitment Status : Terminated
First Posted : January 27, 2003
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Lisata Therapeutics, Inc.

Brief Summary:

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 or disease Intervention/treatment Phase
Kidney Cancer Biological: Biological/Vaccine: therapeutic autologous dendritic cells. Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2001
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Overall survival beginning at the date of study entry [ Time Frame: 5 years or until death, whichever came first. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00014131


Locations
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United States, California
Hoag Cancer Center at Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Sponsors and Collaborators
Lisata Therapeutics, Inc.
Investigators
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Study Chair: Robert O. Dillman, MD, FACP Hoag Memorial Hospital Presbyterian
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Responsible Party: Lisata Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00014131    
Other Study ID Numbers: CDR0000068493
HOAG-VACCINE-RN ( Other Identifier: Hoag Cancer Center at Hoag Memorial Hospital Presbyterian )
NCI-V01-1647 ( Other Identifier: National Cancer Institute )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Keywords provided by Lisata Therapeutics, Inc.:
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer
Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type