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Vaccine Therapy in Treating Patients With Stage IV or Recurrent Melanoma

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: NCT00012064
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 29, 2014
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: therapeutic autologous dendritic cells Phase 1 Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vaccine Biotherapy of Cancer: Tumor Cells and Dendritic Cells as Active Specific Immunotherapy of Patients With Metastatic Melanoma
Study Start Date : July 2000
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arms and Interventions

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: 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.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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): NCT00012064


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

Publications:
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.

Responsible Party: Caladrius Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00012064     History of Changes
Other Study ID Numbers: CDR0000068481
HOAG-VACCINE-MEL
NCI-V01-1646
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: August 2013

Keywords provided by Caladrius Biosciences, Inc.:
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Vaccines
Immunologic Factors
Physiological Effects of Drugs