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NCT00060528 · ClinicalTrials.gov registry record · Phase 1
Sequential Vaccinations in Prostate Cancer Patients
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT00060528: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00060528 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 32 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00060528, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
Background: " Adenocarcinoma of the prostate is the most common cancer diagnosis in American males and follows lung cancer as the leading cause of cancer death. " Vaccine strategies represent a novel therapeutic approach in the treatment for prostate cancer. One potential target for a prostate cancer vaccine is prostatic specific antigen (PSA), due to its restricted expression on prostate cancer and normal prostatic epithelial cells. Objectives: " The primary objective is to determine the impact of granulocyte-macrophage colony stimulating factor (GM-CSF) and recombinant fowlpox granulocyte-macrophage colony stimulating factor (rF-GM-CSF) on the immunologic response in patients treated with these vaccines. " Secondary - to determine the change in prostatic specific antigen (PSA)-specific T cells in patients treated with these vaccines using enzyme linked immunosorbent spot (ELISPOT) assay analysis. " To document any objective anti-tumor responses that may occur. Eligibility: " Patients must have androgen insensitive metastatic prostate cancer. " All patients will have received and progressed on hormonal therapy. " Must have objective evidence of metastasis or relapsing local disease. Therefore, must have a rising PSA and at least one of the following: positive bone scan, palpable disease, or positive imaging studies. " Must have a life expectancy of more than 6 months and Eastern Cooperative Oncology Group (ECOG) status of 0 to 2. "Patients must be human leukocyte antigen serotype within HLA-A A serotype group (HLA-A2+). " Granulocyte count greater than or equal to 1,500/mm\^3, Platelet greater than or equal to 100,000/mm\^3, hemoglobin (Hgb) greater than or equal to 10Gm/dL, Lymphocyte count greater than or equal to 500/mm\^3 ;Bilirubin less than 1.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5x upper limit of normal (ULN),Creatinine Clearance greater than or equal to 60 " No significant cardiac disease, no s
Interventions
- DRUG Recombinant Fowlpox-GM-CSF
- DRUG Recombinant Fowlpox-PSA (L155)-TRICOM (PROSTVAC-F/TRICOM)
- DRUG Recombinant Vaccinia-PSA (L155)-TRICOM (PROSTVAC-V/TRICOM)
- DRUG Recombinant Human GM-CSF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2003-05-22 |
| Est. Completion | 2009-06-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00060528
The ClinicalTrials.gov registry entry for NCT00060528 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Recombinant Fowlpox-GM-CSF is the first listed.
NCT00060528 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00060528 about?
NCT00060528 is a clinical study titled "Sequential Vaccinations in Prostate Cancer Patients". Background: " Adenocarcinoma of the prostate is the most common cancer diagnosis in American males and follows lung cancer as the leading cause of cancer death. " Vaccine strategies represent a novel therapeutic approach in the treatment for prostate cancer. One potential target for a prostate can...
What is the current status of trial NCT00060528?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2003-05-22. Estimated completion is 2009-06-08.
What interventions are being tested in trial NCT00060528?
The interventions under investigation include: Recombinant Fowlpox-GM-CSF (DRUG), Recombinant Fowlpox-PSA (L155)-TRICOM (PROSTVAC-F/TRICOM) (DRUG), Recombinant Vaccinia-PSA (L155)-TRICOM (PROSTVAC-V/TRICOM) (DRUG), Recombinant Human GM-CSF (DRUG).
Who is sponsoring clinical trial NCT00060528?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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