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

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 neuroen

Trial Details

NCT ID
NCT06202066
Phase
PHASE2
Sponsor
Roswell Park Cancer Institute
Status
RECRUITING
Cancer Type
Pancreatic Neuroendocrine Pancreatic Cancer
Interventions
  • Biospecimen Collection
  • Computed Tomography
  • Incomplete Freund''s Adjuvant
  • Magnetic Resonance Imaging
  • Sargramostim
  • SVN53-67/M57-KLH Peptide Vaccine
Locations (sample)
  • Buffalo, New York, United States|42.88645,-78.87837

Key Eligibility Criteria

  • 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…
  • Measurable, pathologically confirmed diagnosis of neuroendocrine tumor of gastrointestinal, pancreatic, or thoracic origin with ki67\>20% (well-dif…
  • Patients must have documented radiographic progression, determined as clinically significant by the treating provider, within the last twelve month…

For full eligibility, visit ClinicalTrials.gov.

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