Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
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.Inclusion Criteria
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (obtained within 14 days prior to enrollment)
I can take care of myself with little help.
My neuroendocrine tumor tissue tests positive for survivin.
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Exclusion Criteria
I have previously been treated with SurVaxM.
I am currently pregnant or breastfeeding.
I do not have any serious illnesses that my doctor thinks could make this treatment unsafe for me.
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Participant Groups
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.
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.
SurVaxM is already approved in United States for the following indications:
🇺🇸 Approved in United States as SurVaxM for:
- None approved yet; under investigation for glioblastoma, malignant gliomas, neuroendocrine tumors, multiple myeloma, medulloblastoma, high-grade glioma, ependymoma, and diffuse intrinsic pontine glioma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Roswell Park Cancer InstituteBuffalo, NY
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Who Is Running the Clinical Trial?
Roswell Park Cancer InstituteLead Sponsor