Past/Closed Clinical Trials
The trials listed below are closed and no longer accruing patients. Evaluation of the Effects of Local GM-CSF-in-adjuvant Administration on Dendritic Cells in Skin of Melanoma Patients and in Sentinel Lymph Nodes Mel 44 Trial A Multicenter Trial to Evaluate the Effects of Administration of Cyclophosphamide and Melanoma-Derived Helper Peptides on the Immunogenicity of a Class I MHC-Restricted Peptide-Based Vaccine in Participants with Resected Melanoma E1602 trial (for patients with stage IV melanoma) A Randomized Phase II Trial of Multi-Epitope Vaccination with Melanoma Peptides for Cytotoxic T-cells and Helper T-cells for Patients with Metastatic Melanoma BMS 004 trial A Phase I Multiple Ascending Dose Study of BMS-663513, an Agonistic Anti-CD137 Monoclonal Antibody, Administered in Combination with Chemotherapy to Subjects with Advanced Solid Malignancies. E2603 trial (for patients with unresectable stage III or stage IV melanoma) A Double-Blind, Randomized, Placebo-Controlled Phase III Trial of Carboplatin, Paclitaxel and BAY 43-9006 versus Carboplatin, Paclitaxel and Placebo in Patients with Unresectable Locally Advanced or Stage IV Melanoma
Mel 44 trial (for patients with stage IIB to IV melanoma) GI 37 trial
Evaluation of the Immunogenicity of Vaccination with Her-2/neu and CEA Derived Synthetic Peptides with GM-CSF-in-Adjuvant, in Patients with Stage IIB, III, or IV Colorectal Cancer Study of Peptide 946 Melanoma Vaccine (Peptide 946), Peptide 946 Combined with Tetanus Peptide Melanoma Vaccine, or Peptide 946-Tetanus Peptide Conjugate in Patients with High Risk Melanoma Randomized Study of Antigen-Pulsed Autologous Dendritic Cells for Induction of Antitumor Immunity in Patients Completing Lymphadenectomy for Metastatic Melanoma Mel 33 trial
Randomized Study of Immunotherapy With Polyvalent Melanoma Vaccine (CancerVax) Plus BCG Versus BCG Plus Placebo Following Surgery in Patients With Stage IV Melanoma Mel 36 trial Pilot Phase II Trial for the Evaluation of the Effect of Systemic Low-dose IL-2 on the Immunogenicity of a Vaccine Comprising Synthetic Melanoma Peptides Administered with GM-CSF-in-Adjuvant, in Patients with High Risk Melanoma
Evaluation of the Safety and Immunogenicity of Vaccination with Multiple Synthetic Melanoma Peptides Recognized by Helper T-Cells, in Patients with Advanced Melanoma Phase II Trial for the Evaluation of the Efficacy of Vaccination with Synthetic Melanoma Peptides Administered with GM-CSF-in-Adjuvant in Patients with Advanced Melanoma
Evaluation of Local GM-CSF-in-Adjuvant and the Number of Vaccine Sites on Immunization with Multiple Synthetic Melanoma Peptides
Evaluation of Different Adjuvants for the Transdermal Administration of a Peptide-Based Vaccine in Patients with High-Risk Melanoma
Title: Evaluation of the Effects of Local GM-CSF-in-adjuvant Administration on Dendritic Cells in Skin of Melanoma Patients and in Sentinel Lymph Nodes Objectives: The purpose of this study is to learn what happens to cells at and around the tumor site and in the sentinel lymph node when GM-CSF and adjuvant are injected at the tumor site. Trial SummaryParticipants in this study will be randomized to receive an injection with either GM-CSF alone, adjuvant alone, GM-CSF plus adjuvant, or saline alone at their tumor site prior to surgery and removal of the sentinel lymph node. Cells from part of the tumor and lymph node tissue will be studied in the lab to see how they are reacting to the injection. Title: A Multicenter Trial to Evaluate the Effects of Administration of Cyclophosphamide and Melanoma-Derived Helper Peptides on the Immunogenicity of a Class I MHC-Restricted Peptide-Based Vaccine in Participants with Resected Melanoma Objectives: The purpose of this trial is to determine whether vaccination with synthetic copies of peptides made by melanoma tumor cells in addition to chemotherapy is safe and will initiate an immune response against cancer cells. Trial Summary Four different groups will be studied: Groups A, B, C, and D are listed below with a brief outline of what will be received by patients of each group. Vaccines will be administered once a week for six weeks with a one-week break after the third week. Vaccines will also be administered at weeks 12, 26, 39, and 52. Group A: 12 melanoma peptides plus a tetanus class II MHC-restricted helper peptide in Montanide adjuvant administered intradermally and subcutaneously at two vaccination sites. Group B: Cyclophosphamide administered intravenously. 12 melanoma peptides plus a tetanus class II MHC-restricted helper peptide in Montanide adjuvant administered intradermally and subcutaneously at two vaccination sites. Group C: 12 melanoma peptides plus 6 helper peptides in Montanide adjuvant administered intradermally and subcutaneously at two vaccination sites. Group D: Cyclophosphamide administered intravenously. 12 melanoma peptides plus 6 helper peptides in Montanide adjuvant administered intradermally and subcutaneously at two vaccination sites. Title: A Randomized Phase II Trial of Multi-epitope Vaccination with Melanoma Peptides for Cytotoxic T-Cells and Helper T-Cells for Patients with Metastatic Melanoma Principal Investigator: Craig Slingluff, MD Contact: Emily Stell, Phone:(434)982-6584, E-mail: ems2b@virginia.edu.
The Human Immune Therapy Center of the Cancer Center at the University of Virginia Health System invites adults with melanoma to enroll in a research study. The purpose of the study is to test investigational vaccines to see if they are safe to use in people with melanoma. Prior to, during, and after enrollment, physical examinations, blood tests, CT scans, skin and eye exams, and at week 4, sentinel node biopsy will be required. If enrolled, subjects will be randomly assigned to 1 of 4 groups. Each group will receive a vaccine with a differing formulation. The study involves 6 vaccine treatments over 7 weeks. If the results of these 6 treatments are favorable, participants become eligible to receive 18 booster vaccinations over an additional 2-year time period. All those enrolled will have blood drawn and physical exams during return visits to monitor general health and response to study vaccines. Participants will be followed for five years after the cessation of treatment to monitor for long-term side effects. Participant or participant's insurance will be responsible for the cost of required procedures. There will be no financial compensation for study completion.
E2603 trial
Mel 44 trial Study of Peptide 946 Melanoma Vaccine (Peptide 946), Peptide 946 Combined with Tetanus Peptide Melanoma Vaccine, or Peptide 946-Tetanus Peptide Conjugate in Patients with High Risk Melanoma Rationale: Vaccines made from peptide 946 may make the body build an immune response to kill tumor cells. Combining these vaccines with proteins from the tetanus vaccine, and/or with either QS21 or incomplete Freund's adjuvant may be an effective treatment for metastatic melanoma. Purpose: This is a randomized phase I trial to study the effectiveness of vaccines made from peptide 946 with or without tetanus peptide, QS21, or incomplete Freund's adjuvant in treating patients with metastatic melanoma that cannot be surgically removed or with melanoma that is likely to recur. Eligibility:
Outline: Patients will be randomized to receive one of six vaccines. All the vaccines will contain peptide 946 but will differ depending on whether they contain tetanus peptide, QS21, or incomplete Freund's adjuvant. Patients will be vaccinated on day 1 and then once a month at 1, 2, 3, 6, 9, and 12 months after the start of the trial. Patients will receive a follow-up evaluation at 6 and 12 months after the end of treatment. This abstract is intended to give a brief overview of this clinical trial. To help determine whether the trial is appropriate for an individual, selected major eligibility criteria are listed above. Randomized Study of Antigen-Pulsed Autologous Dendritic Cells for Induction of Antitumor Immunity in Patients Completing Lymphadenectomy for Metastatic Melanoma Rationale: Vaccines made from a person's white blood cells and melanoma cells may make the body build an immune response and kill the tumor cells. Purpose: Randomized phase I/II trial to study the effectiveness of vaccine therapy made from white blood cells and melanoma cells in treating patients with metastatic melanoma who are undergoing surgery for lymph node and tumor removal. Eligibility:
Outline: Approximately 1-2 weeks following surgery for lymph node and tumor removal, patients will undergo leukapheresis to collect their white blood cells. Patients will receive a vaccine made from white blood cells and melanoma cells. Vaccine therapy will be followed by injections of interleukin-2 twice a day for 3 days. Patients will receive treatment once a month for 4 months. Patients will receive follow-up evaluations for 5 years. This abstract is intended to give a brief overview of this clinical trial. To help determine whether the trial is appropriate for an individual, selected major eligibility criteria are listed above.
Mel 33 trial Rationale: Vaccines may make the body build an immune response that will kill tumor cells. It is not yet known whether BCG vaccine plus melanoma vaccine is more effective than BCG vaccine alone after surgery to remove stage IV melanoma. Purpose: Randomized phase III trial to compare the effectiveness of BCG vaccine with or without melanoma vaccine in treating patients who have undergone surgery to remove stage IV melanoma. Eligibility:
Outline: Patients will be randomized to receive either melanoma vaccine or a placebo every 2 weeks for five courses. They will then receive treatment once every 4 weeks for the first year, once every 8 weeks for the second year, and then once every 12 weeks for the next 3 years. All patients will also receive the BCG vaccine with the first two courses of treatment. Treatment may continue for up to 5 years. Quality of life will be assessed before the first treatment, at 2, 6, and 12 months, and then every 6 months for the next 4 years. Patients will be evaluated at 1, 2, 4, 6, 9, and 12 months, every 4 months for the second year, and then every 6 months for the next 3 years. This abstract is intended to give a brief overview of this clinical trial. To help determine whether the trial is appropriate for an individual, selected major eligibility criteria are listed above. Mel 36 trial 
Pilot Phase II Trial for the Evaluation of the Effect of Systemic Low-dose IL-2 on the Immunogenicity of a Vaccine Comprising Synthetic Melanoma Peptides Administered with GM-CSF-in-Adjuvant, in Patients with High Risk Melanoma Rationale: In an original clinical trial of vaccination with four melanoma peptides, the same peptides that will be used in the current trial, we have observed prominent T-cell responses in the sentinel immunized lymph nodes. However, toxicity associated with the vaccine regimen appears to be largely attributable to the IL-2. Though there is rationale for including IL-2 in the proposed vaccine, its value in this setting is not known. The clinical study proposed here is a pilot study that will test the hypothesis that systemic Low-dose IL-2 therapy significantly enhances the immunologic efficacy of a vaccine comprising melanoma peptides plus GM-CSF-in-adjuvant. Eligibility:
Evaluation of the Safety and Immunogenicity of Vaccination with Multiple Synthetic Melanoma Peptides Recognized by Helper T-Cells, in Patients with Advanced Melanoma Objectives: The goal of this study is to see if an experimental vaccine composed of synthetic copies of peptides made by melanoma tumor cells safely causes an immune response against melanoma when administered in GM-CSF and Montanide. Eligibility: Patients must fit the following criteria:
Outline:
Patients enrolled in this study will be randomly assigned to receive a low, medium, or high dose of peptide vaccine. The dose of vaccine does not always equal the best immune response. The vaccine will be given once a week for six weeks. On day 22, the sentinel immunized node (the lymph node draining the vaccination site) will be removed to see if the immune system is responding to the vaccine. Phase II Trial for the Evaluation of the Efficacy of Vaccination with Synthetic Melanoma Peptides Administered with GM-CSF-in-Adjuvant in Patients with Advanced Melanoma Rationale: The peptides used in this vaccine are synthetic copies of peptides made by melanoma tumor cells. In theory, vaccinating with these peptides in GM-CSF and Montanide will activate the immune system to recognize and kill melanoma tumor cells. GM-CSF is known to attract dendritic cells (a type of white blood cell that starts immune responses in the body) and Montanide allows for slow release of GM-CSF. Objectives: The purpose of this trial is to determine if an experimental vaccine will cause a melanoma tumor to shrink or stop growing by initiating an immune response against the tumor cells. Eligibility : Patients must fit the following criteria.
Outline: Tumor will be removed prior to receiving vaccines. Vaccines will then be given once a week for six weeks. On day 22, the lymph node draining the vaccination site will be removed using a common procedure to see of the immune system is responding to the vaccine. Blood will be drawn six times during the study.
Learn more about the sentinel lymph node biopsy Evaluation of Local GM-CSF-in-Adjuvant and the Number of Vaccine Sites on Immunization with Multiple Synthetic Melanoma Peptides Rationale: The peptides used in this vaccine are synthetic copies of peptides made by melanoma tumor cells. In theory, vaccinating with these peptides in GM-CSF and/or Montanide will activate the immune system to recognize and kill melanoma tumor cells. GM-CSF is known to attract dendritic cells (a type of white blood cell that starts immune responses in the body) and Montanide allows for slow release of GM-CSF. Objectives: The purpose of this trial is to determine if GM-CSF and vaccination at two sites instead of one cause greater immune responses. Eligibility: Patients must fit the following criteria.
Outline: Four different groups will be studied: Groups A, B, C, and D are listed below with a brief outline of what will be received by patients of each group.
Group A: 12 melanoma peptides and Montanide at one vaccination site
Vaccines will be given once a week for six weeks. Blood will be drawn six times during the study. Evaluation of Different Adjuvants for the Transdermal Administration of a Peptide-Based Vaccine in Patients with High-Risk Melanoma Objectives: The purpose of this trial is to determine if trandsdermal vaccination with synthetic copies of peptides made by melanoma tumor cells in GM-CSF and Montanide in different adjuvants will initiate an immune response against tumor cells. Eligibility: Patients must fit the following criteria.
Outline: Four different groups will be studied: Arms 1, 2, 3, and 4 are listed below with a brief outline of what will be received by patients of each group.
Arm 1: 12 melanoma peptides, GM-CSF, and Montanide administered transdermally for the first three vaccinations and intradermally and subcutaneously for the remaining six vaccinations |