Temozolomide and SurVaxM for Metastatic Neuroendocrine Tumors
This study is looking at a new way to treat neuroendocrine tumors (NETs) that have spread to other parts of the body (metastatic) and are getting worse. It combines a chemotherapy drug called temozolomide with a vaccine called SurVaxM. Temozolomide works by damaging cancer cell DNA to slow or stop tumor growth. SurVaxM targets a protein called survivin, which is often found in NETs and linked to poorer outcomes. The study aims to see how safe and effective this combination is compared to temozolomide alone. You might be able to join if you are 18 or older, can care for yourself, and have a confirmed diagnosis of a neuroendocrine tumor of the digestive system, lung, or pancreas that is growing. The study plans to enroll 60 participants.
- Study design
- This is a Phase IIa interventional study comparing temozolomide combined with SurVaxM to temozolomide alone. It plans to enroll 60 participants.
- What's involved
- You would receive temozolomide by mouth daily for 5 days, repeated every 28 days for up to a year. You would also undergo blood sample collection, CT scans, and MRI scans.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure how long you live without your cancer getting worse (progression-free survival) at 6 months, and track any side effects for up to 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06202066
Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Carcinomas
Suspended
PHASE2Ages 18+InterventionalTreatmentRoswell Park Cancer InstituteInvestigator-initiated
~60 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyIncomplete Freund''s AdjuvantMagnetic Resonance ImagingSargramostimSVN53-67/M57-KLH Peptide Vaccine
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival (PFS)
Measured over At 6 months
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Jasmeet Kaur, MD · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age ≥ 18 years of age
Have a Karnofsky performance status ≥ 80 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)
Measurable, pathologically confirmed diagnosis of neuroendocrine tumor of gastrointestinal, pancreatic, or thoracic origin with ki67\>20% (well-differentiated G3 NETs) or neuroendocrine carcinoma of any origin excluding small cell lung carcinoma
Patients must have documented radiographic progression, determined as clinically significant by the treating provider, within the last twelve months on two 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)
Patients must have failed at least one prior systemic therapy
Patients who have been on somatostatin analogues (SSA) may continue to take SSA while on study treatment
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)
Creatinine clearance ≥ 60 mL/min (per Cockroft-Gault equation) (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 bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices, which carries a significant risk of bleeding in investigator's opinion)
Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure
Exclusion
Patients who have received temozolomide in the advanced disease setting either alone or as part of a combination therapy will be excluded if they progressed while on it
Has received prior treatment with SurVaxM
Received an investigational agent within 30 days prior to enrollment
Participants who have received checkpoint inhibitors within 3 months prior to study enrollment or, those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, bradycardia, tachycardia or psychiatric illness/social situations that would limit compliance with study requirements and, which in the treating physicians' opinion would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety
Patients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin. Patients who have been free of disease (any prior malignancy) for at least 3 years are eligible for this study
Known history of an autoimmune disorder
Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness or other serious medical illness
Systemic corticosteroid therapy \> 2mg of dexamethasone or equivalent per day at study entry
Pregnant or nursing female participants
Unwilling or unable to follow protocol requirements
Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug
Patients with Hepatitis B or Hepatitis C may be included if there are adequately controlled viral titers and no drug-drug interactions, testing not required
What this trial measures
- Progression free survival (PFS)At 6 months
Summarized using frequencies and relative frequencies.
- Incidence of adverse eventsUp to 1 year
Defined using National Cancer Institute (NCI) Common Terminology Criteria for Adverse events (CTCAE) version (v) 5.0. Adverse events will be summarized by attribution and grade using frequencies and relative frequencies.