Survivin Long Peptide Vaccine in Treating Patients With Metastatic Neuroendocrine Tumors

  • STATUS
    Recruiting
  • End date
    Aug 17, 2024
  • participants needed
    10
  • sponsor
    Roswell Park Cancer Institute
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Updated on 4 October 2022
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Summary

This phase I trial studies the side effects of survivin long peptide vaccine and how it works with the immune system in treating patients with neuroendocrine tumors that have spread to other parts of the body (metastatic). Tumor cells make proteins that are not usually produced by normal cells. The body sees these proteins as not belonging and sends white blood cells called T cells to attack the tumor cells that contain these proteins. By vaccinating with small pieces of these proteins called peptides, the immune system can be made to kill tumor cells. Giving survivin long peptide vaccine to patients who have survivin expression in their tumors may create an immune response in the blood that is directed against neuroendocrine tumors.

Description

PRIMARY OBJECTIVES:

I. To assess safety, tolerability and toxicity of SVN53-67/M57-KLH peptide vaccine (SurVaxM) in emulsion with incomplete Freund's adjuvant (montanide ISA 51) and given subcutaneously with sargramostim (granulocyte macrophage-colony-stimulating factor [GM-CSF]) in combination with a somatostatin analogue, octreotide acetate (Sandostatin LAR) in patients with survivin positive metastatic neuroendocrine tumors (NETs).

SECONDARY OBJECTIVES:

I. To determine clinical benefit (including complete response, partial response and stable disease as defined by Response Evaluation Criteria in Solid Tumors [RECIST] version [v]1.1) at 6 months, 9 months and 12 months from study entry.

II. To evaluate the immunogenicity of SurVaxM in NETs by measuring anti-survivin antibody levels and anti-tumor T-cell responses in peripheral blood.

III. To determine time to progression (TTP) compared to prior to study entry, in patients with metastatic NETs treated with SurVaxM.

EXPLORATORY OBJECTIVES:

I. To explore immune markers associated with clinical responses to SurVaxM in peripheral blood of NETs patients.

OUTLINE

Patients receive a SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant subcutaneously (SC) and sargramostim SC on day 0. Treatment repeats every 2 weeks for up to 4 doses in the absence of disease progression or unacceptable toxicity. Patients also receive octreotide acetate intramuscularly (IM) on day 0. Cycles of octreotide acetate repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity. Patients who remain free of tumor progression at 6 months and do not develop any regimen-related toxicity or serious adverse events will be eligible to receive additional doses of the vaccine and sargramostim every 3 months, for up to 1 year from the start of treatment.

After completion of study treatment, patients are followed up for 3 months.

Details
Condition Lung Atypical Carcinoid Tumor, Lung Typical Carcinoid Tumor, Metastatic Pancreatic Neuroendocrine Tumor
Treatment sargramostim, incomplete Freund's adjuvant, SVN53-67/M57-KLH Peptide Vaccine, Octreotide Acetate, Octreotide Acetate
Clinical Study IdentifierNCT03879694
SponsorRoswell Park Cancer Institute
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Have a Karnofsky performance status >= 70 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)
Pathologically confirmed diagnosis of neuroendocrine tumor of gastrointestinal, pancreatic or lung origin
Patients who have been on somatostatin analogues (SSA) may continue to take SSA while on study treatment
Patients must have documented progression within the last six months on CT or MRI scans performed at least four weeks apart per RECIST v1.1 criteria
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) > 9.0 g/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) =< 4.0 x ULN (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)
Creatinine =< 1.8 mg/dl (obtained within 14 days of enrollment)
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 and, have a negative pregnancy test prior to starting study treatment. 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

The patient must not have received any immunotherapy for any malignancy,as long as it was > 3 months prior to study start
Patients with serious concurrent infection or medical illness, 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 who are pregnant or breast-feeding
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
Previous local therapy (e.g. chemo-embolization, bland, or radio-embolization) is allowed if completed > 6 weeks prior to randomization. For subjects who received local therapy prior to randomization, there must be documented growth of measurable disease within the embolization field prior to study
Unwilling or unable to follow protocol requirements
Systemic corticosteroid therapy > 2 mg of dexamethasone or equivalent per day at study entry
Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
Received an investigational agent within 30 days prior to enrollment
Clinically significant cardiac arrhythmia, bradycardia, tachycardia that would compromise patient safety or the outcome of the study
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