Trial Outcomes & Findings for Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma (NCT NCT00398073)
NCT ID: NCT00398073
Last Updated: 2017-03-16
Results Overview
All toxicity will be graded according to the National Cancer Institute (NCI) Common Toxicity Criteria v3.0.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
35 participants
Primary outcome timeframe
2 years
Results posted on
2017-03-16
Participant Flow
Participant milestones
| Measure |
1_Particle-medicated Epidermal Delivery Group (Gene Gun)
patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.
mouse gp100 plasmid DNA vaccine
|
2_IM Injection (Bioinjector)
patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.
mouse gp100 plasmid DNA vaccine
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
17
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
1_Particle-medicated Epidermal Delivery Group (Gene Gun)
patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.
mouse gp100 plasmid DNA vaccine
|
2_IM Injection (Bioinjector)
patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.
mouse gp100 plasmid DNA vaccine
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
Baseline characteristics by cohort
| Measure |
1_Particle-medicated Epidermal Delivery Group (Gene Gun)
n=17 Participants
patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.
mouse gp100 plasmid DNA vaccine
|
2_IM Injection (Bioinjector)
n=17 Participants
patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.
mouse gp100 plasmid DNA vaccine
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsAll toxicity will be graded according to the National Cancer Institute (NCI) Common Toxicity Criteria v3.0.
Outcome measures
| Measure |
1_Particle-medicated Epidermal Delivery Group (Gene Gun)
n=17 Participants
patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.
mouse gp100 plasmid DNA vaccine
|
2_IM Injection (Bioinjector)
n=17 Participants
patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.
mouse gp100 plasmid DNA vaccine
|
|---|---|---|
|
Number of Patients Evulated for Toxicity and Safety
|
17 participants
|
17 participants
|
PRIMARY outcome
Timeframe: 2 yearsT-cell response: Peripheral blood lymphocytes will be tested for reactivity against gp100 using an IFN-y ELISPOT, intracellular cytokine staining or MHC tetramer assay. If T-cell reactivity is induced, additional samples may be drawn to determine the duration of this reactivity. Follow-up blood samples require only 20-30 ml. MHC tetramer assays and intracellular flow cytometry studies may also be performed.
Outcome measures
| Measure |
1_Particle-medicated Epidermal Delivery Group (Gene Gun)
n=17 Participants
patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.
mouse gp100 plasmid DNA vaccine
|
2_IM Injection (Bioinjector)
n=17 Participants
patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.
mouse gp100 plasmid DNA vaccine
|
|---|---|---|
|
Number of Participants With a T-cell Response
|
17 participants
|
17 participants
|
SECONDARY outcome
Timeframe: 2 yearsIn patients with measurable disease, the RECIST criteria for anti-tumor effect will be used. Lesions will be defined as measurable if they can be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques or as \> 10 mm by spiral CT scan.Complete Response (CR): Disappearance of all target lesions. 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 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 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 |
1_Particle-medicated Epidermal Delivery Group (Gene Gun)
n=17 Participants
patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.
mouse gp100 plasmid DNA vaccine
|
2_IM Injection (Bioinjector)
n=17 Participants
patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.
mouse gp100 plasmid DNA vaccine
|
|---|---|---|
|
Number of Participants With Response
|
17 participants
|
17 participants
|
Adverse Events
1_Particle-medicated Epidermal Delivery Group (Gene Gun)
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
2_IM Injection (Bioinjector)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1_Particle-medicated Epidermal Delivery Group (Gene Gun)
n=17 participants at risk
patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.
mouse gp100 plasmid DNA vaccine
|
2_IM Injection (Bioinjector)
n=17 participants at risk
patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.
mouse gp100 plasmid DNA vaccine
|
|---|---|---|
|
Immune system disorders
Allergy/Immunology, other
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Allergy/Immunology, other
|
5.9%
1/17
|
0.00%
0/17
|
|
Blood and lymphatic system disorders
Edema: limb
|
5.9%
1/17
|
0.00%
0/17
|
|
General disorders
Pain - Chest/thorax NOS
|
0.00%
0/17
|
5.9%
1/17
|
Other adverse events
| Measure |
1_Particle-medicated Epidermal Delivery Group (Gene Gun)
n=17 participants at risk
patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.
mouse gp100 plasmid DNA vaccine
|
2_IM Injection (Bioinjector)
n=17 participants at risk
patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.
mouse gp100 plasmid DNA vaccine
|
|---|---|---|
|
Metabolism and nutrition disorders
AST, SGOT
|
5.9%
1/17
|
0.00%
0/17
|
|
Hepatobiliary disorders
Bilirubin (hyperbilirubinemia)
|
11.8%
2/17
|
17.6%
3/17
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
17.6%
3/17
|
17.6%
3/17
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
5.9%
1/17
|
0.00%
0/17
|
Additional Information
Jedd Wolchok, MD, Chief Attending
Memorial Sloan Kettering Cancer Center
Phone: +1646-888-2315
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place