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Cancer Vaccine

PART 1 (temozolomide, SurVaxM) for Neuroendocrine Tumors

Phase 2

Waitlist Available

Led By Renuka V Iyer

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Archival neuroendocrine tumor tissue must test positive for survivin presence by clinical immunohistochemistry prior to study enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial is comparing the safety and effectiveness of using a combination of temozolomide and a vaccine called SurVaxM, versus using temozolomide alone, in patients with neuro

Who is the study for?

This trial is for patients with neuroendocrine tumors that have spread and are worsening. Participants should not have had prior treatment with temozolomide or the vaccine being tested, and must be able to undergo MRI or CT scans.Check my eligibility

What is being tested?

The study is testing if combining a drug called temozolomide with a new vaccine (SurVaxM) is more effective than using temozolomide alone in treating spreading neuroendocrine tumors. Patients will receive both treatments or just the drug.See study design

What are the potential side effects?

Temozolomide may cause nausea, fatigue, constipation, headache, and low blood cell counts leading to increased infection risk. The SurVaxM vaccine could potentially cause injection site reactions and flu-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself with little help.

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My neuroendocrine tumor tissue tests positive for survivin.

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I am on full-dose anticoagulants and meet the specific criteria.

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I am 18 years old or older.

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I have a confirmed neuroendocrine tumor in my gut, pancreas, or lungs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events (Part 1)

PFS (Part 2)

Progression free survival (PFS) (Part 1)

Secondary outcome measures

Incidence of adverse events (Part 2)

OS (Part 2)

Overall survival (OS) (Part 1)

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: PART 1 (temozolomide, SurVaxM)Experimental Treatment7 Interventions

Patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity and can be continued at investigators discretion at end of treatment. Patients also receive SurVaxM with montanide ISA-51 SC and sargramostim SC once every 2 weeks for 4 doses. Patients with clinical benefit after 4 doses of SurVaxM and remain free of tumor progression and unacceptable toxicity may receive 3 additional doses on weeks 24, 36, and 48. Additionally, patients undergo blood sample collection, CT scans or MRI scans throughout study.

Group II: ARM II (temozolomide, SurVaxM)Experimental Treatment7 Interventions

Patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days until disease progression or unacceptable toxicity and can be continued at investigators discretion at end of treatment. Patients also receive SurVaxM with Montanide ISA-51 SC and sargramostim SC once every 2 weeks for 4 doses. Patients with clinical benefit after 4 doses of SurVaxM and remain free of tumor progression and unacceptable toxicity may receive 3 additional doses on weeks 24, 36, and 48. Additionally, patients undergo blood sample collection, CT scans or MRI scans throughout study.

Group III: ARM I (temozolomide)Experimental Treatment4 Interventions

Patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days until disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT scans or MRI scans throughout study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1730

Computed Tomography

2017

Completed Phase 2

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Sargramostim

2008

Completed Phase 4

~710

Temozolomide

2010

Completed Phase 3

~1930

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor

402 Previous Clinical Trials

30,726 Total Patients Enrolled

4 Trials studying Neuroendocrine Tumors

151 Patients Enrolled for Neuroendocrine Tumors

Renuka V IyerPrincipal InvestigatorRoswell Park Cancer Institute

1 Previous Clinical Trials

14 Total Patients Enrolled

1 Trials studying Neuroendocrine Tumors

14 Patients Enrolled for Neuroendocrine Tumors

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial currently open for enrollment?

"According to the current information available on clinicaltrials.gov, this specific clinical trial is not actively seeking participants. However, it's worth noting that there are currently 2592 other ongoing clinical trials actively recruiting patients at this time."

Answered by AI

Has the Food and Drug Administration (FDA) given their approval for ARM I, specifically temozolomide?

"The safety rating of ARM I (temozolomide) is estimated to be 2, according to our team at Power. This evaluation is based on the fact that this trial is in Phase 2, indicating some existing data supporting its safety but no evidence yet regarding its effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06202066.

All > Neuroendocrine Tumor