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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA105696 | U.S. NIH Grant/Contract | View source | |
| P30CA006973 | U.S. NIH Grant/Contract | View source | |
| JHOC-J0323 | |||
| JHOC-03-05-06-02 | Other Identifier | JHM IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Vaccines made from protein and DNA may help the body build an effective immune response to kill abnormal cells in the cervix. The use of vaccine therapy may prevent cervical cancer.
PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy and to see how well it works in preventing cervical cancer in patients with cervical intraepithelial neoplasia and human papillomavirus.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Cohorts of patients receive escalating doses of vaccine until the safest dose is determined.
After completion of the study treatment, patients are followed annually for 15 years.
PROJECTED ACCRUAL: Approximately 150 patients (approximately 12 will be treated in phase I and 25 will be treated in phase II) will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose | Experimental | 3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM at one month intervals. Genetic (recombinant DNA vaccine) |
|
| Intermediate dose | Experimental | 3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM at one month intervals Genetic (recombinant DNA vaccine) |
|
| High dose | Experimental | 3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM at one month intervals Genetic (recombinant DNA vaccine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine | Biological | recombinant DNA vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Toxicity | Number of participants with serious adverse events (SAE) according to CTCAE 3.0 grading. | for the duration of the study, and whenever possible, for an additional 5 years |
| Efficacy | The efficacy of pNGVL4a-SigE7(detox)HSP70 DNA vaccine, administered intra-muscularly. This is reported as number of participants with histologic regression of CIN2/3 to CIN1 or less by colposcopically-directed biopsy. | for the duration of the study, and whenever possible, for an additional 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Regression of CIN3 Lesions | Number of participants with absence of CIN3 lesions at week 15 | 15 weeks |
| Number of Participants With T-cell Immune Responses in the Blood | Systemic T-cell response as measured by γ-INF enzyme-linked immunospot assays (ELISpot) |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
- Age: > 18
Other
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| Name | Affiliation | Role |
|---|---|---|
| Cornelia L. Trimble, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19118066 | Result | Trimble CL, Peng S, Kos F, Gravitt P, Viscidi R, Sugar E, Pardoll D, Wu TC. A phase I trial of a human papillomavirus DNA vaccine for HPV16+ cervical intraepithelial neoplasia 2/3. Clin Cancer Res. 2009 Jan 1;15(1):361-7. doi: 10.1158/1078-0432.CCR-08-1725. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose | 3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine |
| FG001 | Intermediate Dose | 3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine |
| FG002 | High Dose | 3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose | 3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine |
| BG001 | Intermediate Dose | 3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Participants age 18 and older |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety and Toxicity | Number of participants with serious adverse events (SAE) according to CTCAE 3.0 grading. | per protocol | Posted | Count of Participants | Participants | for the duration of the study, and whenever possible, for an additional 5 years |
|
19 weeks
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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 | Low Dose | 3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue/tiredness, flu-like symptoms | General disorders | Non-systematic Assessment |
The trial was completed, as planned.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cornelia L. Trimble, MD | Johns Hopkins University | 410-502-0512 | ctrimbl@jhmi.edu |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D011230 | Precancerous Conditions |
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| 41 weeks |
| Number of Participants With Correlated Measures of Immune Response With Clinical Response | Number of participants whose t-cell immune responses correlated with histologic regression of disease or viral clearance of HPV | 9 months |
| Number of Participants With Correlated Measures of Immune Responses With the Preclinical Model | Number of participants whose T-cell immune responses correlated with the immune responses observed in the preclinical model | 9 months |
| BG002 | High Dose | 3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine |
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Participants ages 18 and older | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| High Dose |
3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine |
|
|
| Primary | Efficacy | The efficacy of pNGVL4a-SigE7(detox)HSP70 DNA vaccine, administered intra-muscularly. This is reported as number of participants with histologic regression of CIN2/3 to CIN1 or less by colposcopically-directed biopsy. | per protocol | Posted | Count of Participants | Participants | for the duration of the study, and whenever possible, for an additional 5 years |
|
|
|
| Secondary | Regression of CIN3 Lesions | Number of participants with absence of CIN3 lesions at week 15 | per protocol; participants who had no CIN3 lesions assessed by colposcopy and biopsy(ies) at the week 15 visit | Posted | Count of Participants | Participants | 15 weeks |
|
|
|
| Secondary | Number of Participants With T-cell Immune Responses in the Blood | Systemic T-cell response as measured by γ-INF enzyme-linked immunospot assays (ELISpot) | all patients who completed all 3 vaccinations | Posted | Count of Participants | Participants | 41 weeks |
|
|
|
| Secondary | Number of Participants With Correlated Measures of Immune Response With Clinical Response | Number of participants whose t-cell immune responses correlated with histologic regression of disease or viral clearance of HPV | All participants who received all 3 vaccinations | Posted | Count of Participants | Participants | 9 months |
|
|
|
| Secondary | Number of Participants With Correlated Measures of Immune Responses With the Preclinical Model | Number of participants whose T-cell immune responses correlated with the immune responses observed in the preclinical model | Posted | Count of Participants | Participants | 9 months |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | Intermediate Dose | 3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine | 0 | 3 | 0 | 3 | 2 | 3 |
| EG002 | High Dose | 3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine | 0 | 9 | 0 | 9 | 5 | 9 |
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Injection site reaction | General disorders | Non-systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hot flashes | Vascular disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |