Pilot Study for the Evaluation of the Efficacy of Vaccination With Autologous Tumor Cells Plus Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) - in - Adjuvant, Followed by Systemic Low-dose-interleukin-2 (IL-2) Administration, in Patients With High Risk Melanoma (MEL37)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Virginia
ClinicalTrials.gov Identifier:
NCT00912418
First received: June 1, 2009
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

This study is an open-label, pilot study of an autologous tumor cell vaccine.


Condition Intervention
Melanoma
Biological: autologous tumor cells plus GM-CSF-in Adjuvant

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study for the Evaluation of the Efficacy of Vaccination With Autologous Tumor Cells Plus GM-CSF-in-adjuvant, Followed by Systemic Low-dose-IL-2 Administration, in Patients With High Risk Melanoma.

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Cytotoxic T-cell response to autologous tumor (as measured by staining assay) [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cytotoxic T-cell response to defined melanoma antigens. 1: Activation antigen expression by lymph node T-cells 2: Delayed-type hypersensitivity response to autologous tumor cells. 3: Antibody response to autologous tumor cells. [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: January 2000
Intervention Details:
    Biological: autologous tumor cells plus GM-CSF-in Adjuvant

    Autologous tumor cells plus 225 ug GM-CSF in-adjuvant: The autologous tumor cells will be administered intradermally. Subjects will be vaccinated over at least a 6 week period (at weeks 0, 1, 2, 4, 5, 6), with responders vaccinated every 4 weeks thereafter for a maximum of 9 vaccinations (up to week 18). Systemic low-dose interleukin-2 will also be administered daily for 6 weeks following the second vaccination at week 1.

    Concurrent with the first three of these vaccinations, each patient will also receive an additional set of 3 vaccinations in a different site, the response to which will be evaluated at the draining lymph node. This node will be harvested using lymphatic mapping and sentinel node biopsy methods.

Detailed Description:

Regimen: A vaccine comprising autologous melanoma cells plus GM-CSF in-adjuvant will be administered intradermally at a single dose. Subjects will be vaccinated over at least a 6 week period (at weeks 0, 1, 2, 4, 5, 6), with responders vaccinated every 4 weeks thereafter for a maximum of 9 vaccinations (up to week 18). Systemic low-dose interleukin-2 will also be administered daily for 6 weeks following the second vaccination at week 1.

Concurrent with the first three of these vaccinations, each patient will also receive an additional set of 3 vaccinations in a different site, the response to which will be evaluated at the draining lymph node. This node will be harvested using lymphatic mapping and sentinel node biopsy methods.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have been diagnosed, by cytologic or histologic examination, with stage III or stage IV melanoma, where sufficient resected tumor is available for vaccine preparation (approximately 3 g tumor).
  • Measurable tumor after resection is not required.
  • Patients with up to 3 brain metastases may be included if the metastases are all < 2 cm in diameter, are asymptomatic, and there is no mass effect or they have been treated successfully by surgical excision or by gamma knife radiation therapy.
  • Patients who have had a larger number of brain metastases resected or treated and resolved after gamma knife radiation therapy may be included if their status at the time of study initiation meets these criteria.
  • For those patients with resected melanoma, surgical resections must have been performed within 6 months prior to entry. All patients must have:

    • ECOG performance status 0-1, and, ability and willingness to give informed consent.
    • Laboratory parameters as follows: ANC > 1000/mm3, and Platelets > 100,000 and Hgb > 10.
    • Hepatic: AST and ALT up to 1.5 x upper limits of normal (ULN), Bilirubin within ULN, Alkaline phosphatase up to 1.5 x ULN
    • Renal: Creatinine within ULN
    • Serology: HIV negative, Hepatitis C virus-negative.
  • Patients who are not candidates for interferon, for people who decide not to take interferon, or for people who have failed interferon therapy (those patients who have progressed while on interferon therapy or who experienced a major toxicity while receiving treatment).

Exclusion Criteria:

  • Patients who are currently receiving cytotoxic chemotherapy or radiation therapy, or who have received that therapy within the preceding 4 weeks.
  • Patients who are currently receiving investigational agents, or who have received investigational agents within the preceding 30 days.
  • Patients with known or suspected allergies to any component of the vaccine.
  • Patients receiving the following medications at study entry or within 30 days are excluded:

    • Allergy desensitization injections
    • Corticosteroids, administered parenterally or orally.
  • Topical corticosteroids are acceptable, Any growth factors, Interferons, Interleukin 2 (IL-2).
  • Prior melanoma vaccinations will not be an exclusion criteria if given more than 8 weeks previously, but will be recorded, and data analysis will take this into account.
  • Other investigational drugs or investigational therapy also will not necessarily be an exclusion criteria, but will similarly be recorded and taken into account during data analysis.
  • Pregnancy or the possibility of becoming pregnant during vaccine administration.
  • Female patients of child-bearing potential must have a negative pregnancy test (urinary or serum beta-HCG) prior to administration of the first vaccine dose.
  • Males and females must agree, in the consent form, to use effective birth control methods during the course of vaccination. This is consistent with existing standards of practice for vaccine and chemotherapy protocols.
  • Patients in whom there is a medical contraindication or other potential medical problem in complying with the requirements of the protocol, in the opinion of the investigator.
  • Patients classified according to the New York Heart Association classification system as having Class II, III or IV heart disease.
  • Patients with active connective tissue disease requiring medications, or other severe autoimmune disease.
  • Patients who are actively hyperthyroid.
  • Patients with uncontrolled diabetes.
  • Patients with known allergies to penicillin, streptomycin, and amphotericin B.
  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: NCT00912418

Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Craig L Slingluff, MD University of Virginia
  More Information

No publications provided

Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT00912418     History of Changes
Other Study ID Numbers: 8577
Study First Received: June 1, 2009
Last Updated: June 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Virginia:
melanoma
vaccine
IL2 low dose

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 16, 2014