Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019110
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2001-07-11
Brief Title:
Vaccine Therapy in Treating Patients With Advanced or Recurrent Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
VACCINE THERAPY AND DETECTION OF IMMUNOLOGIC RESPONSES WITH HUMAN PAPILLOMAVIRUS 16 E6 AND E7 PEPTIDES IN PATIENTS WITH METASTATIC OR LOCALLY ADVANCED CERVICAL CANCER
Status:
COMPLETED
Status Verified Date:
1999-11
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 made from certain human papillomaviruses may be able to help the body to kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of human papillomavirus vaccine therapy in treating patients who have advanced or recurrent cancer of the cervix vagina penis anus esophagus or head and neck
PURPOSE Phase II trial to study the effectiveness of human papillomavirus vaccine therapy in treating patients who have advanced or recurrent cancer of the cervix vagina penis anus esophagus or head and neck
Detailed Description:
OBJECTIVES
Determine whether endogenous cellular immunity to the viral oncoproteins human papilloma virus 16 HPV16 E6 and E7 is present in patients with advanced or recurrent carcinoma of the cervix or other carcinomas that carry HPV16
Determine whether vaccination with antigen-presenting cells pulsed with synthetic peptide corresponding to the tumors HPV16 E6 or E7 peptide can induce or boost patient cellular immunity to that particular peptide
Determine the type and characteristics of the cellular immunity generated in patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine the tumor response in patients treated with this regimen
Determine whether in vivo T cells generated specifically against HPV16 E6 or E7 peptide can be cloned and expanded in vitro against the corresponding peptide
OUTLINE Patients are stratified according to disease category as defined by the following
Stratum A Stage III cervical cancer not previously treated with appropriate radiotherapy stage IV or recurrent cervical cancer or other advanced tumors that harbor human papilloma virus 16 HPV16 such as anogenital esophageal or head and neck cancers
Stratum B Stage III cervical cancer previously treated with standard therapy with no evidence of residual disease Vaccination in this group is given as adjuvant therapy
Patients are assigned to receive HPV E6 or E7 peptide by the principal investigator Peripheral blood mononuclear cells PBMC antigen presenting cells are harvested and treated in vitro with sargramostim GM-CSF and pulsed with HPV16 E6 or E7 Patients receive vaccination with HPV16 E6 or E7 pulsed PBMC IV over 1-2 minutes during weeks 1 3 7 and 11 for a total of 4 vaccinations Treatment continues in the absence of disease progression or unacceptable toxicity Patients who achieve complete response CR continue treatment for a maximum of 1 year past CR
Patients are followed at 1 month
PROJECTED ACCRUAL A total of 40-46 patients at least 28 patients for stratum A and 12 for stratum B will be accrued for this study within 1-2 years
Determine whether endogenous cellular immunity to the viral oncoproteins human papilloma virus 16 HPV16 E6 and E7 is present in patients with advanced or recurrent carcinoma of the cervix or other carcinomas that carry HPV16
Determine whether vaccination with antigen-presenting cells pulsed with synthetic peptide corresponding to the tumors HPV16 E6 or E7 peptide can induce or boost patient cellular immunity to that particular peptide
Determine the type and characteristics of the cellular immunity generated in patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine the tumor response in patients treated with this regimen
Determine whether in vivo T cells generated specifically against HPV16 E6 or E7 peptide can be cloned and expanded in vitro against the corresponding peptide
OUTLINE Patients are stratified according to disease category as defined by the following
Stratum A Stage III cervical cancer not previously treated with appropriate radiotherapy stage IV or recurrent cervical cancer or other advanced tumors that harbor human papilloma virus 16 HPV16 such as anogenital esophageal or head and neck cancers
Stratum B Stage III cervical cancer previously treated with standard therapy with no evidence of residual disease Vaccination in this group is given as adjuvant therapy
Patients are assigned to receive HPV E6 or E7 peptide by the principal investigator Peripheral blood mononuclear cells PBMC antigen presenting cells are harvested and treated in vitro with sargramostim GM-CSF and pulsed with HPV16 E6 or E7 Patients receive vaccination with HPV16 E6 or E7 pulsed PBMC IV over 1-2 minutes during weeks 1 3 7 and 11 for a total of 4 vaccinations Treatment continues in the absence of disease progression or unacceptable toxicity Patients who achieve complete response CR continue treatment for a maximum of 1 year past CR
Patients are followed at 1 month
PROJECTED ACCRUAL A total of 40-46 patients at least 28 patients for stratum A and 12 for stratum B will be accrued for this study within 1-2 years
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-T94-0134N | None | None | None |
| NCI-95-C-0154 | None | None | None |