Vaccine Therapy in Treating Patients With Stage IV or Recurrent Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NeoStem, Inc.
ClinicalTrials.gov Identifier:
NCT00012064
First received: March 3, 2001
Last updated: January 27, 2014
Last verified: August 2013
  Purpose

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 Intervention Phase
Melanoma (Skin)
Biological: therapeutic autologous dendritic cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by NeoStem, Inc.:

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 [ Time Frame: treatment ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

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 [ Time Frame: follow-up ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: July 2000
Study Completion Date: April 2011
Primary Completion Date: April 2011 (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: 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 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
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: NCT00012064

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 Memorial Hospital Presbyterian
  More Information

Additional 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: NeoStem, Inc.
ClinicalTrials.gov Identifier: NCT00012064     History of Changes
Other Study ID Numbers: CDR0000068481, HOAG-VACCINE-MEL, NCI-V01-1646
Study First Received: March 3, 2001
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by NeoStem, 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

ClinicalTrials.gov processed this record on September 30, 2014