Not yet recruitingPhase 2

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

A Phase II Study of Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) in Patients With Progressing Metastatic Neuroendocrine Carcinomas (NECs)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 year
  • Procedures mentioned: Blood draws, MRI scans, CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Additionally, patients undergo blood sample collection, computed tomography (CT) scans or magnetic resonance imaging (MRI) scans throughout study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests temozolomide, a cancer drug, with or without SurVaxM, a vaccine meant to help the immune system fight cancer. It compares safety and how well the treatments work in adults with neuroendocrine cancer that has spread and is getting worse.

This phase IIa 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and able to care for yourself with only occasional help.
  • Have a tumor confirmed by a tissue test that can be measured: a grade 3 neuroendocrine tumor from the digestive tract, pancreas, or chest with Ki67 above 20% (a sign of fast cell growth), or neuroendocrine carcinoma from any site except small cell lung cancer.
  • Have cancer that worsened within the past 12 months, shown on two CT or MRI scans at least 4 weeks apart. For repeat treatment, the doctor may use other signs of worsening.
  • Have tried at least one whole-body cancer treatment that did not work.
  • Have stored tumor tissue that tests positive for a protein called survivin.
  • Meet the study’s blood cell count, liver, and kidney test limits within 14 days before joining.
  • If taking full-dose blood thinners, have no active bleeding or condition with a high risk of bleeding.
  • Agree to use birth control if able to become pregnant, and understand the study and sign a consent form.

Who can't join

  • Your advanced cancer worsened while taking temozolomide, or you have received SurVaxM before.
  • You received an experimental drug within 30 days or checkpoint inhibitors (a type of immune treatment) within 3 months before joining, or have not recovered from side effects of drugs given more than 4 weeks earlier.
  • You have an uncontrolled illness, such as an infection or heart problem, or another health or personal issue that could make treatment unsafe or prevent you from following study rules.
  • You have another current or past cancer, unless it was cured cancer limited to its starting layer or basal cell skin cancer, or you have been cancer-free for at least 3 years.
  • You have a known autoimmune disease, where the immune system attacks your own body.
  • You have HIV, an AIDS-related illness, or another serious illness. Hepatitis B or C may be allowed if virus levels are well controlled and medicines do not interact.
  • You take more than 2 mg of dexamethasone daily, or an equal dose of another steroid that acts throughout the body, when joining.
  • You are pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age ≥ 18 years of age * 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) * Measurable, pathologically confirmed diagnosis of neuroendocrine tumor of gastrointestinal, pancreatic, or thoracic origin with ki67\>20% (well-differentiated G3 NETs) or neuroendocrine carcinoma of any origin excluding small cell lung carcinoma * Patients must have documented radiographic progression, determined as clinically significant by the treating provider, within the last twelve months on two CT or MRI scans performed at least four weeks apart per RECIST v1.1 criteria. In the case of retreatment, progression may be defined by the treating provider (e.g., clinical, radiographic, biochemical) * Patients must have failed at least one prior systemic therapy * Patients who have been on somatostatin analogues (SSA) may continue to take SSA while on study treatment * Archival neuroendocrine tumor tissue must test positive for survivin presence by clinical immunohistochemistry prior to study enrollment * Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (obtained within 14 days prior to enrollment) * Platelets ≥ 100 x 10\^9/L (obtained within 14 days prior to enrollment) * Hemoglobin (Hgb) \> 9g/dL (obtained within 14 days prior to enrollment) * Plasma total bilirubin: ≤ 1.5 x upper limit of normal (ULN) (obtained within 14 days prior to enrollment) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 4 x ULN (obtained within 14 days prior to enrollment) * Creatinine clearance ≥ 60 mL/min (per Cockroft-Gault equation) (obtained within 14 days prior to enrollment) * Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight \[LMW\] heparin) must meet the following criteria: * No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices, which carries a significant risk of bleeding in investigator's opinion) * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Patients who have received temozolomide in the advanced disease setting either alone or as part of a combination therapy will be excluded if they progressed while on it * Has received prior treatment with SurVaxM * Received an investigational agent within 30 days prior to enrollment * Participants who have received checkpoint inhibitors within 3 months prior to study enrollment or, those who have not recovered from adverse events due to agents administered more than 4 weeks earlier * 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 * Patients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin. Patients who have been free of disease (any prior malignancy) for at least 3 years are eligible for this study * Known history of an autoimmune disorder * Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness or other serious medical illness * Systemic corticosteroid therapy \> 2mg of dexamethasone or equivalent per day at study entry * Pregnant or nursing female participants * Unwilling or unable to follow protocol requirements * Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug * Patients with Hepatitis B or Hepatitis C may be included if there are adequately controlled viral titers and no drug-drug interactions, testing not required

Study sites (1)

NY