Trial Outcomes & Findings for Universal Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)-Producing and CD40L Expressing Bystander Cell Line for Tumor Vaccine in Melanoma (NCT NCT00101166)
NCT ID: NCT00101166
Last Updated: 2018-02-28
Results Overview
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.
COMPLETED
PHASE2
43 participants
Average of 14 months
2018-02-28
Participant Flow
43 patients with Stage IV melanoma were enrolled between November 2004 and May 2007. Fifteen of these patients did not receive any vaccine.
Participant milestones
| Measure |
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.
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Overall Study
STARTED
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28
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Overall Study
COMPLETED
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18
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Overall Study
NOT COMPLETED
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10
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Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
progressive disease
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10
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Baseline Characteristics
Universal Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)-Producing and CD40L Expressing Bystander Cell Line for Tumor Vaccine in Melanoma
Baseline characteristics by cohort
| Measure |
Vaccine Therapy
n=28 Participants
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.
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Age, Continuous
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60 years
n=99 Participants
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Sex: Female, Male
Female
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8 Participants
n=99 Participants
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Sex: Female, Male
Male
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20 Participants
n=99 Participants
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Region of Enrollment
United States
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28 participants
n=99 Participants
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PRIMARY outcome
Timeframe: Average of 14 monthsPopulation: All 28 participants who were vaccinated on this study.
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.
Outcome measures
| Measure |
Vaccine Therapy
n=28 Participants
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.
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Number of Participants With Partial Response
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1 participants
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SECONDARY outcome
Timeframe: Average of 14 monthsPopulation: All 28 participants who were vaccinated on this study.
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).
Outcome measures
| Measure |
Vaccine Therapy
n=28 Participants
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.
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Number of Participants With Serious Adverse Events (SAEs) Related to Study Treatment
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0 participants
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SECONDARY outcome
Timeframe: Average of 14 monthsPopulation: All 28 participants who were vaccinated on this study.
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.
Outcome measures
| Measure |
Vaccine Therapy
n=28 Participants
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.
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Number of Participants With Stable Disease
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8 participants
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SECONDARY outcome
Timeframe: Average of 14 monthsPopulation: All 28 participants who were vaccinated on this study.
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.
Outcome measures
| Measure |
Vaccine Therapy
n=28 Participants
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.
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Time to Progression (TTP) in Months
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3.8 months
Interval 3.0 to 38.0
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SECONDARY outcome
Timeframe: Average of 14 monthsPopulation: All 28 participants who were vaccinated on this study.
Average overall survival time in months.
Outcome measures
| Measure |
Vaccine Therapy
n=28 Participants
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.
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|---|---|
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Overall Survival (OS) in Months
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12.8 months
Interval 3.0 to 38.0
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Adverse Events
Vaccine Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vaccine Therapy
n=28 participants at risk
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.
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Cardiac disorders
Pain - Cardiac - Unrelated
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3.6%
1/28 • Number of events 1 • 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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Skin and subcutaneous tissue disorders
Transient localized erythema
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35.7%
10/28 • Number of events 10 • 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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Skin and subcutaneous tissue disorders
mild pruritis
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3.6%
1/28 • Number of events 1 • 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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Skin and subcutaneous tissue disorders
Localized depigmentation
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3.6%
1/28 • Number of events 1 • 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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Skin and subcutaneous tissue disorders
Induration
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3.6%
1/28 • Number of events 1 • 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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Additional Information
Dr. Sophie Dessureault
H. Lee Moffitt Cancer Center and Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place