Actively Recruiting
Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for Patients With Progressing Metastatic Neuroendocrine Carcinomas
Led by Roswell Park Cancer Institute · Updated on 2026-05-28
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of combining the drug temozolomide with a survivin long peptide vaccine called SurVaxM in patients with progressing metastatic neuroendocrine tumors (NETs). These tumors have spread from their original site to other parts of the body and are growing or worsening. This phase IIa trial aims to determine how well the combination treatment works compared to temozolomide alone, focusing on progression-free survival and safety. Survivin is a protein found in about half of NET patients and is linked to worse outcomes, making it a target for the vaccine. Participants receive temozolomide orally once daily for five days in a 28-day cycle, continuing for up to one year unless the disease progresses or side effects become unacceptable. Alongside, they get SurVaxM vaccine injections with adjuvants subcutaneously every two weeks for four doses. Those who benefit and show no progression may receive three additional vaccine doses at weeks 24, 36, and 48. During the study, patients also undergo blood tests and imaging scans like CT or MRI to monitor tumor status. Throughout the trial, researchers collect blood samples and perform imaging scans to assess tumor growth and immune response. They monitor participants closely for side effects and measure outcomes such as progression-free survival at six months and adverse events up to one year. After treatment ends, patients have a follow-up visit 30 days later. The study also explores immune markers and tumor growth rates to better understand responses to the vaccine and drug combination.
CONDITIONS
Brief Title
Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Carcinomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Karnofsky performance status of 80 or higher or ECOG performance status of 0 or 1
- Measurable, pathologically confirmed neuroendocrine tumor of gastrointestinal, pancreatic, or thoracic origin with Ki67 >20% or neuroendocrine carcinoma excluding small cell lung carcinoma
- Documented radiographic progression within the last 12 months on two CT or MRI scans at least 4 weeks apart
- Failed at least one prior systemic therapy
- May continue somatostatin analogues if previously used
- Archival tumor tissue positive for survivin by immunohistochemistry
- Absolute neutrophil count ≥ 1.5 x 10^9/L within 14 days prior to enrollment
- Platelets ≥ 100 x 10^9/L within 14 days prior to enrollment
- Hemoglobin > 9g/dL within 14 days prior to enrollment
- Plasma total bilirubin ≤ 1.5 x upper limit of normal within 14 days prior to enrollment
- ALT and AST ≤ 4 x upper limit of normal within 14 days prior to enrollment
- Creatinine clearance ≥ 60 mL/min within 14 days prior to enrollment
- Patients on full-dose anticoagulants must have no active bleeding or high-risk bleeding conditions
- Participants of child-bearing potential must use adequate contraception
- Must understand investigational nature and sign informed consent
You will not qualify if you...
- Prior temozolomide treatment in advanced disease with progression
- Prior treatment with SurVaxM
- Received investigational agents within 30 days prior to enrollment
- Received checkpoint inhibitors within 3 months prior or unresolved adverse events from earlier treatment
- Uncontrolled illness including active infection, heart conditions, arrhythmias, psychiatric illness or social situations limiting compliance
- Concurrent or prior malignancy unless disease-free for at least 3 years or treated carcinoma-in-situ or basal cell carcinoma
- Known autoimmune disorders
- Known HIV/AIDS or other serious medical illness
- Systemic corticosteroid therapy > 2mg dexamethasone or equivalent per day at entry
- Pregnant or nursing females
- Unable or unwilling to follow protocol requirements
- Any condition deeming participant unsuitable by Investigator
- Hepatitis B or C with uncontrolled viral titers or drug interactions (testing not required)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive temozolomide orally once daily on days 1 to 5 of each 28-day cycle for up to 1 year, along with SurVaxM vaccine and sargramostim subcutaneously every 2 weeks for 4 doses. Participants with clinical benefit may receive 3 additional vaccine doses at weeks 24, 36, and 48. Blood samples and imaging scans are collected throughout treatment.
Every 2 weeks for vaccine doses and temozolomide cycles every 28 days; imaging and blood sample collection at multiple timepoints throughout treatment
Duration - 30 days
After completing treatment, participants are followed up to assess safety and disease status.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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