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NCT00088413 · ClinicalTrials.gov registry record · Phase 1
PANVAC-V and PANVAC-F Vaccines Plus Sargramostim to Treat Advanced Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT00088413: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00088413 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 51 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00088413, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
Background: * Many cancers produce two proteins, carcinoembryonic antigen (CEA) and mucin-1 (MUC-1). * The PANVAC-V (PANVAC vaccinia) priming vaccine and PANVAC-F (PANVAC fowlpox) boosting vaccine contain human genes that cause production of CEA and MUC-1, which can be used as a target for the immune system to attack the cancer. The vaccines also contain genes that cause production of other proteins that enhance immune activity. * Sargramostim is a protein that boosts the immune system. Objectives: * To evaluate the safety and effectiveness of PANVAC-V and PANVAC-F in patients with advanced cancer. * To document the immune response to the vaccines and any anti-tumor responses that may occur. Eligibility: Patients 18 years of age and older with advanced cancer whose tumors produce CEA or MUC-1 protein Design: * This trial has three cohorts: the first cohort includes 10 patients with advanced colorectal cancer and 10 to 15 patients with any advanced non-colorectal cancer that produces either EA or mitochondrial Ca2+ uniporter 1 (MCU-1); the second cohort includes 12 patients with advanced breast cancer and the third cohort includes 14 patients with advanced ovarian cancer. * All patients receive PANVAC-V on study day 1, followed by PANVAC-F on days 15, 29 and 43 then every 28 days for up to 12 vaccines followed by every 3 months until disease progression or toxicity. The vaccines are given by injection under the skin. Sargramostim is injected at the vaccination site on the day of each vaccination and for the next 3 days following vaccination. * Patients whose scans show that their disease has progressed, but who are otherwise clinically stable may revert back to monthly injections. * Patients undergo apheresis to collect white blood cells (lymphocytes) on day 1 and day 71 of the study to measure the immune response to the treatment. Blood is collected through a needle placed in one arm and directed through a cell separator machine where the lymphocytes are extra
Interventions
- DRUG Sargramostim (GM-CSF, Leukine)
- BIOLOGICAL PANVAC-V
- BIOLOGICAL PANVAC-F
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2004-07-21 |
| Est. Completion | 2018-05-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00088413
The ClinicalTrials.gov registry entry for NCT00088413 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 51 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 3 interventions - of which Sargramostim (GM-CSF, Leukine) is the first listed.
NCT00088413 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00088413 about?
NCT00088413 is a clinical study titled "PANVAC-V and PANVAC-F Vaccines Plus Sargramostim to Treat Advanced Cancer". Background: * Many cancers produce two proteins, carcinoembryonic antigen (CEA) and mucin-1 (MUC-1). * The PANVAC-V (PANVAC vaccinia) priming vaccine and PANVAC-F (PANVAC fowlpox) boosting vaccine contain human genes that cause production of CEA and MUC-1, which can be used as a target for the immu...
What is the current status of trial NCT00088413?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2004-07-21. Estimated completion is 2018-05-31.
What interventions are being tested in trial NCT00088413?
The interventions under investigation include: Sargramostim (GM-CSF, Leukine) (DRUG), PANVAC-V (BIOLOGICAL), PANVAC-F (BIOLOGICAL).
Who is sponsoring clinical trial NCT00088413?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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