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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06202066
Other study ID # I 3622923
Secondary ID NCI-2023-09345I
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date July 15, 2024
Est. completion date January 15, 2028

Study information

Verified date May 2024
Source Roswell Park Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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Locations

Country Name City State
United States Roswell Park Cancer Institute Buffalo New York

Sponsors (1)

Lead Sponsor Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression free survival (PFS) (Part 1) Summarized using frequencies and relative frequencies. At 6 months
Primary Incidence of adverse events (Part 1) Defined using National Cancer Institute (NCI) Common Terminology Criteria for Adverse events (CTCAE) version (v) 5.0. Adverse events will be summarized by attribution and grade using frequencies and relative frequencies. Up to 1 year
Primary PFS (Part 2) Clinical benefit compared between treatment arms. PFS will be summarized by study arm using frequencies and relative frequencies. At 6 months
Secondary Response (Part 1) Assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. Response will be summarized by time-point using frequencies and relative frequencies. Clinical benefit (best response of complete response [CR], partial response [PR] or stable disease [SD]) will be estimated and summarized using frequencies and relative frequencies, with a 95% confidence interval obtained for the clinical benefit rate. At 3, 6, 9 and 12 months from study entry
Secondary Overall survival (OS) (Part 1) OS will be summarized using standard Kaplan-Meier methods, where the median will be estimated with a 95% confidence interval. At the time from treatment initiation until death due to any cause up to 1 year
Secondary Time to progression (TTP) (Part 1) Defined using RECIST v1.1. TTP will be summarized using standard Kaplan-Meier methods, where the median will be estimated with a 95% confidence interval. At the time from treatment initiation until disease progression, death or last follow up up to 1 year
Secondary Titer response (Part 1) Defined as anti-survivin IgG titers > 30,000 and will be summarized using frequencies and relative frequencies. Up to 1 year
Secondary Response (Part 2) Assessed using RECIST v1.1. Response will be summarized by study arm and timepoint using frequencies and relative frequencies. Clinical benefit (best response of CR, PR, or SD) will be estimated and summarized by study arm using frequencies and relative frequencies, with a 95% confidence interval obtained for the clinical benefit rate. At 6, 9, and 12 months from study entry
Secondary OS (Part 2) OS will be summarized by study arm using standard Kaplan-Meier methods, where the median will be estimated with a 95% confidence interval. At time from treatment initiation until death due to any cause up to 1 year
Secondary TTP (Part 2) Assessed using RECIST v1.1. TTP will be summarized by study arm using standard Kaplan-Meier methods, where the median will be estimated with a 95% confidence interval. At time from treatment initiation until disease progression, death or last follow-up up to 1 year
Secondary Titer response (Part 2) Defined as anti-survivin IgG titers > 30,000 and will be summarized by study arm using frequencies and relative frequencies. Up to 1 year
Secondary Incidence of adverse events (Part 2) Adverse events are defined using NCI CTCAE v5.0 and will be summarized by attribution, study arm, and grade using frequencies and relative frequencies. Up to 1 year
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