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Vaccine Therapy in Treating Patients With Kidney Cancer

Primary Purpose

Kidney Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Biological/Vaccine: therapeutic autologous dendritic cells.
Sponsored by
Lisata Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hoag Cancer Center at Hoag Memorial Hospital Presbyterian

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biological/Vaccine

Arm Description

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.

Outcomes

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
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
Progression-free survival as measured by RECIST at months 2 or 3 and 6 during study treatment and every 6 months after study completion
Event-free survival as measured by RECIST at months 2 or 3 and 6 during study treatment and every 6 months after study completion
Overall survival beginning at the date of study entry

Secondary Outcome Measures

Full Information

First Posted
April 10, 2001
Last Updated
October 2, 2023
Sponsor
Lisata Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00014131
Brief Title
Vaccine Therapy in Treating Patients With Kidney Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
change in corporate priorities
Study Start Date
November 2001 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lisata Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biological/Vaccine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Biological/Vaccine: therapeutic autologous dendritic cells.
Intervention Description
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 Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
Overall survival beginning at the date of study entry
Time Frame
5 years or until death, whichever came first.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert O. Dillman, MD, FACP
Organizational Affiliation
Hoag Memorial Hospital Presbyterian
Official's Role
Study Chair
Facility Information:
Facility Name
Hoag Cancer Center at Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Vaccine Therapy in Treating Patients With Kidney Cancer

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