Study on Temozolomide and Survivin Vaccine for Treating Worsening Metastatic Neuroendocrine Tumors

Sponsor: Roswell Park Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06202066

Provider View

This clinical trial is testing a combination of the drug temozolomide and a vaccine called SurVaxM to see if it can better treat neuroendocrine tumors that have spread and are getting worse. The study compares this combination to using temozolomide alone.

Patient Parameters

Program Overview

This phase II study is exploring whether combining the drug temozolomide with a vaccine called SurVaxM can more effectively treat neuroendocrine tumors that have spread and are worsening. Temozolomide works by damaging the DNA of cancer cells, potentially killing them or stopping their growth. SurVaxM is a vaccine that targets a protein called survivin, which is found in many neuroendocrine tumors and is linked to poor outcomes. The vaccine aims to trigger the immune system to attack cancer cells with survivin, possibly preventing new tumor growth. The study will compare the effects of the combination treatment to temozolomide alone.

Description

The study has two main parts:

Part 1:

  • Patients take temozolomide by mouth once a day for five days in a row, repeating this cycle every 28 days for up to a year, unless the cancer worsens or side effects become too severe.
  • Patients also receive the SurVaxM vaccine under the skin every two weeks for four doses. If the treatment is helping and there are no severe side effects, patients may receive three more doses at weeks 24, 36, and 48.
  • Throughout the study, patients will have blood tests and scans to monitor their health and the cancer's response.

Part 2:

  • Patients are randomly assigned to one of two groups:
    • Group 1: Receives temozolomide alone, following the same schedule as in Part 1.
    • Group 2: Receives both temozolomide and the SurVaxM vaccine, following the same schedule as in Part 1.
  • Patients in both groups will have regular blood tests and scans.

After finishing the study treatment, patients will have a follow-up visit 30 days later.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must be able to care for themselves with occasional help.
  • Must have a confirmed diagnosis of neuroendocrine tumor from the gastrointestinal tract, pancreas, or lungs.
  • The cancer must have shown significant growth or spread in the last 12 months, as seen on scans.
  • Must have tried at least one other treatment that didn't work.
  • Can continue taking somatostatin analogues if already on them.
  • Tumor tissue must test positive for the survivin protein.
  • Must have certain blood counts and organ function levels within normal ranges.
  • Must agree to use effective birth control during the study.
  • Must understand the study and sign a consent form.

Exclusion Criteria

  • Cannot have previously taken temozolomide for advanced cancer.
  • Cannot have received the SurVaxM vaccine before.
  • Cannot have taken an experimental drug within 30 days before the study.
  • Cannot have taken checkpoint inhibitors within 3 months before the study.
  • Cannot have uncontrolled illnesses or conditions that would make it unsafe to participate.
  • Cannot have another active cancer, unless it was treated and cured.
  • Cannot have a history of autoimmune disorders.
  • Cannot have uncontrolled HIV, Hepatitis B, or Hepatitis C.
  • Cannot be taking high doses of steroids.
  • Cannot be pregnant or breastfeeding.
  • Must be willing and able to follow study requirements.

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