|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 11, 2001 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | June 2000 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Cellular immunity as measured by Elispot assay and 51 Cr-release assay at baseline and every 3 weeks [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Cellular immunity as measured by Elispot assay and 51 Cr-release assay at baseline and every 3 weeks | ||||
| Change History | Complete list of historical versions of study NCT00019903 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE |
|
||||
| Descriptive Information | |||||
| Brief Title ICMJE | p53 Vaccine in Treating Patients With Adenocarcinoma of the Ovary Who Have Either No Evidence of Disease or Elevated Biomarkers | ||||
| Official Title ICMJE | Vaccine Therapy With Tumor Specific p53 Peptides in Adult Patients With Low BurdenAdenocarcinoma of the Ovary | ||||
| Brief Summary | RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: This phase I/II trial is studying the side effects of p53 vaccine therapy and to see how well it works in treating patients with adenocarcinoma of the ovary with either no evidence of disease or elevated biomarkers. |
||||
| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: All patients undergo apheresis prior to therapy, prior to every other course, and 1 month after the last course. Patients are assigned to one of two treatment arms.
Patients are followed at 1 month. Patients who are off therapy are followed every 2-4 months for 2 years. PROJECTED ACCRUAL: A total of 45 patients (9-16 per treatment arm) will be accrued for this study within 2 years. |
||||
| Study Phase | Phase I, Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE | Ovarian Cancer | ||||
| Intervention ICMJE |
|
||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 45 | ||||
| Completion Date | |||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Immunologic:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
|
||||
| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00019903 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000067278, NCI-99-C-0137, NCI-NMOB-9903, NCI-T99-0074 | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | January 2007 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||