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

Recruiting Phase 2 Interventional Study
Digestive System Neuroendocrine Neoplasm Lung Neuroendocrine Neoplasm Malignant Solid Neoplasm Pancreatic Neuroendocrine Neoplasm
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Roswell Park Cancer Institute · Other
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About This Trial
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 alky…
Trial Locations
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Eligibility Criteria
Inclusion 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 for himself/ herself with occasional help from others) * Measurable, pathologically confirmed diagnosis o…
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