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

NCT00912418 | Completed

• 1 other identifier: 8577
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Melanoma

Keywords

melanoma; vaccine; IL2 low dose

Outcome Measures

Primary Outcomes (1)

• Cytotoxic T-cell response to autologous tumor (as measured by staining assay)

Secondary Outcomes (1)

• 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.

Interventions

autologous tumor cells plus GM-CSF-in Adjuvant BIOLOGICAL

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Craig L Slingluff, Jr: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Craig L Slingluff, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Human Immune Therapy Center

Study Record Dates

• First Submitted: June 1, 2009
• First Posted: June 3, 2009
• Study Start: May 1, 2000
• Primary Completion: September 17, 2002
• Study Completion: October 9, 2002
• Last Updated: March 2, 2020

Record last verified: 2020-02

Locations

US (1)