Survivin Long Peptide Vaccine in Treating Patients With Metastatic Neuroendocrine Tumors (NCT03879694) | Clinical Trial Compass
CompletedPhase 1
Survivin Long Peptide Vaccine in Treating Patients With Metastatic Neuroendocrine Tumors
United States19 participantsStarted 2019-06-17
Plain-language summary
This phase I trial studies the side effects of survivin long peptide vaccine and how it works with the immune system in treating patients with neuroendocrine tumors that have spread to other parts of the body (metastatic). Tumor cells make proteins that are not usually produced by normal cells. The body sees these proteins as not belonging and sends white blood cells called T cells to attack the tumor cells that contain these proteins. By vaccinating with small pieces of these proteins called peptides, the immune system can be made to kill tumor cells. Giving survivin long peptide vaccine to patients who have survivin expression in their tumors may create an immune response in the blood that is directed against neuroendocrine tumors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have a Karnofsky performance status \>= 70 or Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (i.e. the patient must be able to care for himself/ herself with occasional help from others).
* Pathologically confirmed diagnosis of neuroendocrine tumor of gastrointestinal, pancreatic or lung origin.
* Patients who have been on somatostatin analogues (SSA) may continue to take SSA while on study treatment.
* Patients must have documented progression within the last six months on CT or MRI scans performed at least four weeks apart per RECIST v1.1 criteria. In the case of retreatment, progression may be defined by the treating provider (e.g., clinical, radiographic, biochemical).
* Archival neuroendocrine tumor tissue must test positive for survivin presence by clinical immunohistochemistry prior to study enrollment
* Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (obtained within 14 days prior to enrollment).
* Platelets \>= 100 x 10\^9/L (obtained within 14 days prior to enrollment).
* Hemoglobin (Hgb) \> 9g/dL (obtained within 14 days prior to enrollment).
* Plasma total bilirubin: =\< 1.5 x upper limit of normal (ULN) (obtained within 14 days prior to enrollment).
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 4 x ULN (obtained within 14 days prior to enrollment).
* Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight \[LMW\] heparin) must meet the following criteria:
* No active …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events of SVN53-67/M57-KLH peptide vaccine in combination with octreotide acetate in patients with neuroendocrine tumors