Past Clinical Trials
The trials listed below are closed and no longer accruing patients. 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
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 Click here for trial information. Return to the top
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 Click here for trial information.Return to the top Mel 32 trial Randomized Study of Antigen-Pulsed Autologous Dendritic Cells for Induction of Antitumor Immunity in Patients Completing Lymphadenectomy for Metastatic Melanoma Click here for trial information.Return to the top 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
Click here for trial information. Mel 41 trial
Evaluation of the Safety and Immunogenicity of Vaccination with Multiple Synthetic Melanoma Peptides Recognized by Helper T-Cells, in Patients with Advanced Melanoma Mel 42 trial
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 Mel 43 trial
Evaluation of Local GM-CSF-in-Adjuvant and the Number of Vaccine Sites on Immunization with Multiple Synthetic Melanoma Peptides Mel 45 trial
Evaluation of Different Adjuvants for the Transdermal Administration of a Peptide-Based Vaccine in Patients with High-Risk Melanoma
E2603 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.
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. Click here to 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 |