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| ID | Type | Description | Link |
|---|---|---|---|
| 0407-657 | Other Identifier | OBA |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| American Society of Clinical Oncology | OTHER |
| Society of Surgical Oncology (SSO) | UNKNOWN |
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The purpose of this study is to find out what effects (good and/or bad) this new cancer vaccine has on the patient and their cancer, whether it is safe and whether it can help get rid of their cancer (malignant melanoma). We want to check how the patient's immune system reacts, both before and after the vaccine treatment.
The vaccine will be made by mixing two kinds of cells: 1) some of the patient's own malignant melanoma cells which were removed by surgery and then processed in the Cell Therapy Laboratory, and 2) experimental "bystander" cells. All the cells in the vaccine will be treated with high-dose X-rays to make sure that none of them grow and cause more cancer. The bystander cells, called "GM.CD40L", are human cells that have been genetically changed. The original cells, called K562, had the genes for human GM-CSF and CD40L inserted into them. These changes are designed to help boost the patient's immune system to better fight the cancer in their body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine Therapy | Experimental | Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bystander-Based Autologous Tumor Cell Vaccine | Biological | The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Partial Response | Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. | Average of 14 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) Related to Study Treatment | Frequency of Study Related Toxicity. To evaluate the toxicity of the autologous tumor cell / GM.CD40L bystander cell vaccine. Toxicity was scored using the NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE-3). | Average of 14 months |
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Inclusion Criteria:
Histologically confirmed stage IIIC or stage IV melanoma
Measurable disease
Age 18 or older
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
No radiation therapy within 2 weeks prior to first vaccine administration
No chemotherapy within 4 weeks prior to first vaccine administration
No steroid therapy within 4 weeks prior to first vaccine administration
No surgery within 10 days prior to first vaccine administration
Patient's written informed consent
Patient's ability to comply with the visit schedule and assessments required by the protocol
Adequate organ function (measured within a week of beginning treatment):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sophie Dessureault, M.D., Ph.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612-9497 | United States |
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| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
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43 patients with Stage IV melanoma were enrolled between November 2004 and May 2007. Fifteen of these patients did not receive any vaccine.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vaccine Therapy | Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57. Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Number of Participants With Stable Disease |
Patients with stable disease by RECIST criteria after 3 vaccine injections. Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. |
| Average of 14 months |
| Time to Progression (TTP) in Months | Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | Average of 14 months |
| Overall Survival (OS) in Months | Average overall survival time in months. | Average of 14 months |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Vaccine Therapy | Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57. Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Participants With Serious Adverse Events (SAEs) Related to Study Treatment | Frequency of Study Related Toxicity. To evaluate the toxicity of the autologous tumor cell / GM.CD40L bystander cell vaccine. Toxicity was scored using the NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE-3). | All 28 participants who were vaccinated on this study. | Posted | Number | participants | Average of 14 months |
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| Primary | Number of Participants With Partial Response | Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. | All 28 participants who were vaccinated on this study. | Posted | Number | participants | Average of 14 months |
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| Secondary | Number of Participants With Stable Disease | Patients with stable disease by RECIST criteria after 3 vaccine injections. Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. | All 28 participants who were vaccinated on this study. | Posted | Number | participants | Average of 14 months |
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| Secondary | Time to Progression (TTP) in Months | Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | All 28 participants who were vaccinated on this study. | Posted | Mean | 95% Confidence Interval | months | Average of 14 months |
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| Secondary | Overall Survival (OS) in Months | Average overall survival time in months. | All 28 participants who were vaccinated on this study. | Posted | Mean | 95% Confidence Interval | months | Average of 14 months |
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Average of 14 months. Every 4 weeks throughout the 4 month treatment phase and every 3 months thereafter.
As in our Phase I study, there were no recorded systemic toxicities associated with the vaccine.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vaccine Therapy | Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57. Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm. | 0 | 28 | 10 | 28 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain - Cardiac - Unrelated | Cardiac disorders | CTCAE-3 | Systematic Assessment |
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| Transient localized erythema | Skin and subcutaneous tissue disorders | CTCAE-3 | Systematic Assessment |
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| mild pruritis | Skin and subcutaneous tissue disorders | CTCAE-3 | Systematic Assessment |
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| Localized depigmentation | Skin and subcutaneous tissue disorders | CTCAE-3 | Systematic Assessment |
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| Induration | Skin and subcutaneous tissue disorders | CTCAE-3 | Systematic Assessment |
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Due to the heterogeneity of the patient population, results were mainly descriptive in nature.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sophie Dessureault | H. Lee Moffitt Cancer Center and Research Institute | 813-745-1965 | sophie.dessureault@moffitt.org |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C094534 | polyvalent melanoma cell vaccine |
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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