Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003977
Status:
COMPLETED
Last Update Posted:
2009-02-09
First Post:
1999-11-01
Brief Title:
Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer
Sponsor:
Steward St Elizabeths Medical Center of Boston Inc
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Immunization With Alternating Human Papillomavirus E7 Lipopeptide Epitope Vaccine and Dendritic Cells Presenting the E7 Epitope for the Treatment of Recurrent or Persistent Cervical Cancer
Status:
COMPLETED
Status Verified Date:
2003-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Vaccines may make the body build an immune response to kill tumor cells
PURPOSE Phase I trial to study the effectiveness of vaccine therapy in treating patients with recurrent or persistent cervical cancer that cannot be treated with surgery or radiation therapy
PURPOSE Phase I trial to study the effectiveness of vaccine therapy in treating patients with recurrent or persistent cervical cancer that cannot be treated with surgery or radiation therapy
Detailed Description:
OBJECTIVES
Evaluate alternating vaccination with lipidated human papillomavirus 16 E7 peptide HPV-16 E7 and autologous dendritic cells pulsed with immunogenic HPV-16 E7 in terms of toxicity immunologic reactivity and therapeutic efficacy in patients with recurrent or persistent cervical cancer
OUTLINE This is a dose-escalation study of dendritic cell-human papillomavirus 16 E7 HPV-16 E7 peptide vaccine
Patients undergo leukapheresis to obtain peripheral blood mononuclear cells for activation to dendritic cells on days 0 and 28 Patients receive lipidated HPV-16 E7 peptide vaccine subcutaneously on days 1 and 14 and dendritic cell-HPV-16 E7 peptide vaccine IV over 15-30 minutes on days 7 and 21 Treatment continues in the absence of disease progression or unacceptable toxicity Patients with stable disease or complete or partial response may receive one additional treatment course beginning 6 weeks after the end of the first course
Cohorts of 3-9 patients receive escalating doses of dendritic cell-HPV-16 E7 peptide vaccine The maximum tolerated dose is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
A parallel cohort of patients receives dendritic cell-HPV-16 E7 peptide vaccine IV over 15-30 minutes on days 7 and 14 but does not receive lipidated HPV-16 E7 peptide
Patients are followed at one week
PROJECTED ACCRUAL Approximately 27 patients will be accrued for this study at a rate of 15 patients per year
Evaluate alternating vaccination with lipidated human papillomavirus 16 E7 peptide HPV-16 E7 and autologous dendritic cells pulsed with immunogenic HPV-16 E7 in terms of toxicity immunologic reactivity and therapeutic efficacy in patients with recurrent or persistent cervical cancer
OUTLINE This is a dose-escalation study of dendritic cell-human papillomavirus 16 E7 HPV-16 E7 peptide vaccine
Patients undergo leukapheresis to obtain peripheral blood mononuclear cells for activation to dendritic cells on days 0 and 28 Patients receive lipidated HPV-16 E7 peptide vaccine subcutaneously on days 1 and 14 and dendritic cell-HPV-16 E7 peptide vaccine IV over 15-30 minutes on days 7 and 21 Treatment continues in the absence of disease progression or unacceptable toxicity Patients with stable disease or complete or partial response may receive one additional treatment course beginning 6 weeks after the end of the first course
Cohorts of 3-9 patients receive escalating doses of dendritic cell-HPV-16 E7 peptide vaccine The maximum tolerated dose is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
A parallel cohort of patients receives dendritic cell-HPV-16 E7 peptide vaccine IV over 15-30 minutes on days 7 and 14 but does not receive lipidated HPV-16 E7 peptide
Patients are followed at one week
PROJECTED ACCRUAL Approximately 27 patients will be accrued for this study at a rate of 15 patients per year
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-T98-0072 | None | None | None |
| SEMC-980016 | None | None | None |