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Cancer Vaccine

Temozolomide + SurVaxM for Cancer

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

Must not have

Has received prior treatment with SurVaxM

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, bradycardia, tachycardia or psychiatric illness/social situations that would limit compliance with study requirements and, which in the treating physicians' opinion would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously been treated with SurVaxM.

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I do not have any serious illnesses that my doctor thinks could make this treatment unsafe for me.

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I have HIV/AIDS or another serious illness.

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I am currently pregnant or breastfeeding.

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I am taking more than 2mg of dexamethasone or its equivalent daily.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events (Part 1)

PFS (Part 2)

Progression free survival (PFS) (Part 1)

Secondary study objectives

Incidence of adverse events (Part 2)

OS (Part 2)

Overall survival (OS) (Part 1)

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Temozolomide

2010

Completed Phase 3

~1880

Sargramostim

2006

Completed Phase 4

~850