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Vaccine Therapy in Treating Patients With Stage IV or Recurrent Melanoma

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
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 Melanoma (Skin) focused on measuring stage IV melanoma, recurrent melanoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed stage IV or recurrent melanoma Metastatic disease confirmed by MRI or CT scan Planned resection of tumor No active CNS metastases Radiographically confirmed lack of CNS disease progression No requirement for pharmacologic doses of corticosteroids PATIENT CHARACTERISTICS: Age: Over 16 Performance status: ECOG 0-2 Life expectancy: At least 4 months Hematopoietic: Hematocrit greater than 25% Platelet count greater than 100,000/mm^3 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 Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No underlying cardiac disease associated with known myocardial dysfunction No unstable angina related to atherosclerotic cardiovascular disease Other: No other malignancy within the past 5 years except for carcinoma in situ, basal cell carcinoma, or localized squamous cell skin cancer No active, eminently life-threatening infection or medical condition Adequate venous access Not pregnant Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Other prior putative vaccines allowed Recovered from prior biologic therapy No other 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 endocrine therapy 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 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

To determine the safety of administration of irradiated autologous tumor cells that have been incubated in vitro with gamma interferon, and subsequently injected subcutaneously with autologous dendritic cells and GMCSF
To determine the frequency of conversion of delayed tumor hypersensitivity (DTH) tests with irradiated autologous tumor cells, in patients who received an autologous dendritic cell/tumor cell vaccine with GMCSF

Secondary Outcome Measures

To determine the objective tumor response rate in patients with metastatic melanoma who still had measurable disease at the time vaccine treatment was given

Full Information

First Posted
March 3, 2001
Last Updated
January 27, 2014
Sponsor
Lisata Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00012064
Brief Title
Vaccine Therapy in Treating Patients With Stage IV or Recurrent Melanoma
Official Title
Vaccine Biotherapy of Cancer: Tumor Cells and Dendritic Cells as Active Specific Immunotherapy of Patients With Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (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 person's cancer 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 stage IV or recurrent melanoma.
Detailed Description
OBJECTIVES: Determine the safety of immunization with autologous in vitro-treated tumor cells and dendritic cells in combination with sargramostim (GM-CSF) in patients with stage IV or recurrent melanoma. Determine the frequency of conversion of delayed tumor hypersensitivity tests in patients treated with this regimen. Determine the progression-free and overall survival in patients treated with this regimen. Determine the objective tumor response rate in patients with measurable melanoma treated with this regimen. OUTLINE: Patients are stratified according to presence of measurable disease at study initiation (yes vs no). Patients undergo tumor cell harvest. Patients with multiple persistent sites of metastatic disease after harvest may receive systemic therapy (biologic therapy and/or chemotherapy) during tumor cell line expansion over approximately 4 months. The tumor cell line is expanded, irradiated, and treated with interferon gamma. Patients undergo leukapheresis to collect peripheral blood mononuclear cells (PBMC) to obtain dendritic cells (DC). The PBMC are treated with sargramostim (GM-CSF) and interleukin-4 for 7 days to produce DC. The DC are then cultured with the treated tumor cells for 18 hours. Patients undergo delayed tumor hypersensitivity tests intradermally 1 week prior to vaccination and again at week 4. Patients receive vaccine therapy comprising autologous treated tumor cells and dendritic cells suspended in GM-CSF subcutaneously weekly for 3 weeks. Vaccine therapy continues monthly for an additional 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 30-80 patients 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
Melanoma (Skin)
Keywords
stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (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)
therapeutic autologous dendritic cells
Intervention Description
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
To determine the safety of administration of irradiated autologous tumor cells that have been incubated in vitro with gamma interferon, and subsequently injected subcutaneously with autologous dendritic cells and GMCSF
Time Frame
treatment
Title
To determine the frequency of conversion of delayed tumor hypersensitivity (DTH) tests with irradiated autologous tumor cells, in patients who received an autologous dendritic cell/tumor cell vaccine with GMCSF
Time Frame
treatment
Secondary Outcome Measure Information:
Title
To determine the objective tumor response rate in patients with metastatic melanoma who still had measurable disease at the time vaccine treatment was given
Time Frame
follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage IV or recurrent melanoma Metastatic disease confirmed by MRI or CT scan Planned resection of tumor No active CNS metastases Radiographically confirmed lack of CNS disease progression No requirement for pharmacologic doses of corticosteroids PATIENT CHARACTERISTICS: Age: Over 16 Performance status: ECOG 0-2 Life expectancy: At least 4 months Hematopoietic: Hematocrit greater than 25% Platelet count greater than 100,000/mm^3 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 Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No underlying cardiac disease associated with known myocardial dysfunction No unstable angina related to atherosclerotic cardiovascular disease Other: No other malignancy within the past 5 years except for carcinoma in situ, basal cell carcinoma, or localized squamous cell skin cancer No active, eminently life-threatening infection or medical condition Adequate venous access Not pregnant Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Other prior putative vaccines allowed Recovered from prior biologic therapy No other 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 endocrine therapy 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 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

Citations:
Citation
Dillman RO, Schiltz PM, Selvan R, et al.: Patient-specific cancer vaccine of cultured autologous tumor cells and autologous dendritic cells. [Abstract] J Immunother 24 (5): S5, 2001.
Results Reference
result

Learn more about this trial

Vaccine Therapy in Treating Patients With Stage IV or Recurrent Melanoma

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