Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06202066

Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Carcinomas

Led by Roswell Park Cancer Institute · Updated on 2026-03-11

60

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This phase IIa trial compares the safety and effect of temozolomide combined with survivin long peptide vaccine (SurVaxM) to temozolomide alone in patients with neuroendocrine tumors (NET) that has spread from where it first started (primary site) to other places in the body (metastatic) and is growing, spreading or getting worse (progressing). Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill tumor cells and slow down or stop tumor growth. Survivin, a protein, is expressed in 50% of patients that have neuroendocrine tumors and, is associated with poor outcomes. SVN53-67/M57-KLH peptide vaccine (SurVaxM) is a vaccine that has been shown to produce an immune system response against cancer cells that express a survivin and may block the growth of new tumor cells. Giving temozolomide with SurVaxM may kill more tumor cells in patients with progressing metastatic neuroendocrine tumors.

CONDITIONS

Official Title

Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Carcinomas

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Karnofsky performance status 80 or higher, or ECOG performance status 0 or 1 (able to care for self with occasional help)
  • Measurable, confirmed neuroendocrine tumor from gastrointestinal, pancreatic, or thoracic origin with ki67 >20% or neuroendocrine carcinoma excluding small cell lung carcinoma
  • Documented disease progression within the past 12 months on two imaging scans at least four weeks apart
  • At least one prior systemic therapy failure
  • Patients on somatostatin analogues may continue treatment during the study
  • Archival tumor tissue positive for survivin by immunohistochemistry
  • Absolute neutrophil count ≥ 1.5 x 10^9/L within 14 days before enrollment
  • Platelet count ≥ 100 x 10^9/L within 14 days before enrollment
  • Hemoglobin > 9 g/dL within 14 days before enrollment
  • Plasma total bilirubin ≤ 1.5 times upper normal limit within 14 days before enrollment
  • ALT and AST ≤ 4 times upper normal limit within 14 days before enrollment
  • Creatinine clearance ≥ 60 mL/min within 14 days before enrollment
  • Patients on full-dose anticoagulants must have no active or high-risk bleeding conditions
  • Participants of child-bearing potential must agree to use adequate contraception
  • Must understand the investigational nature and provide informed consent
Not Eligible

You will not qualify if you...

  • Prior treatment with temozolomide in advanced disease if disease progressed during treatment
  • Prior treatment with SurVaxM
  • Use of investigational agents within 30 days before enrollment
  • Use of checkpoint inhibitors within 3 months before enrollment or unresolved adverse events from such agents
  • Uncontrolled illnesses including active infections, serious heart conditions, arrhythmias, or psychiatric/social issues limiting study compliance
  • Concurrent or prior malignancy within 3 years except treated carcinoma-in-situ or basal cell skin carcinoma
  • Known autoimmune disorders
  • HIV positivity, AIDS-related illness, or other serious medical illnesses
  • Systemic corticosteroid therapy above 2 mg dexamethasone or equivalent daily at entry
  • Pregnant or nursing females
  • Unable or unwilling to follow study protocol
  • Any condition making participant unsuitable for study drug as judged by investigator
  • Patients with Hepatitis B or C only if viral levels are controlled and no drug interactions, testing not required

AI-Screening

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Trial Site Locations

Total: 1 location

1

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Actively Recruiting

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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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