Malignant Solid Neoplasm Clinical Trial
Official title:
A Phase II Study of Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) in Patients With Progressing Metastatic Neuroendocrine Tumors (NETs)
Verified date | May 2024 |
Source | Roswell Park Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 132 |
Est. completion date | January 15, 2028 |
Est. primary completion date | January 15, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 lung origin - Patients must have documented radiographic progression, determined as clinically significant by the treating provider, within the last twelve months on 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 (e.g. lanreotide, octreotide, everolimus, sunitinib, or lutetium Lu 177 dotatate) - 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 - 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 or HIV may be included if there are adequately controlled viral titers and no drug-drug interactions |
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Cancer Institute | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
Roswell Park Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression free survival (PFS) (Part 1) | Summarized using frequencies and relative frequencies. | At 6 months | |
Primary | Incidence of adverse events (Part 1) | Defined using National Cancer Institute (NCI) Common Terminology Criteria for Adverse events (CTCAE) version (v) 5.0. Adverse events will be summarized by attribution and grade using frequencies and relative frequencies. | Up to 1 year | |
Primary | PFS (Part 2) | Clinical benefit compared between treatment arms. PFS will be summarized by study arm using frequencies and relative frequencies. | At 6 months | |
Secondary | Response (Part 1) | Assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. Response will be summarized by time-point using frequencies and relative frequencies. Clinical benefit (best response of complete response [CR], partial response [PR] or stable disease [SD]) will be estimated and summarized using frequencies and relative frequencies, with a 95% confidence interval obtained for the clinical benefit rate. | At 3, 6, 9 and 12 months from study entry | |
Secondary | Overall survival (OS) (Part 1) | OS will be summarized using standard Kaplan-Meier methods, where the median will be estimated with a 95% confidence interval. | At the time from treatment initiation until death due to any cause up to 1 year | |
Secondary | Time to progression (TTP) (Part 1) | Defined using RECIST v1.1. TTP will be summarized using standard Kaplan-Meier methods, where the median will be estimated with a 95% confidence interval. | At the time from treatment initiation until disease progression, death or last follow up up to 1 year | |
Secondary | Titer response (Part 1) | Defined as anti-survivin IgG titers > 30,000 and will be summarized using frequencies and relative frequencies. | Up to 1 year | |
Secondary | Response (Part 2) | Assessed using RECIST v1.1. Response will be summarized by study arm and timepoint using frequencies and relative frequencies. Clinical benefit (best response of CR, PR, or SD) will be estimated and summarized by study arm using frequencies and relative frequencies, with a 95% confidence interval obtained for the clinical benefit rate. | At 6, 9, and 12 months from study entry | |
Secondary | OS (Part 2) | OS will be summarized by study arm using standard Kaplan-Meier methods, where the median will be estimated with a 95% confidence interval. | At time from treatment initiation until death due to any cause up to 1 year | |
Secondary | TTP (Part 2) | Assessed using RECIST v1.1. TTP will be summarized by study arm using standard Kaplan-Meier methods, where the median will be estimated with a 95% confidence interval. | At time from treatment initiation until disease progression, death or last follow-up up to 1 year | |
Secondary | Titer response (Part 2) | Defined as anti-survivin IgG titers > 30,000 and will be summarized by study arm using frequencies and relative frequencies. | Up to 1 year | |
Secondary | Incidence of adverse events (Part 2) | Adverse events are defined using NCI CTCAE v5.0 and will be summarized by attribution, study arm, and grade using frequencies and relative frequencies. | Up to 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06030427 -
Virtual Mindfulness and Weight Management to Mitigate Risk of Relapse and Improve Wellbeing in Cancer Survivors
|
N/A | |
Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
Recruiting |
NCT05660421 -
Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors
|
Phase 2 | |
Suspended |
NCT04060849 -
Nozin in Preventing Respiratory Viral Infections in Patients Undergoing Stem Cell Transplant, PREV-NOSE STUDY
|
Phase 1 | |
Recruiting |
NCT06192875 -
A Novel Molecular Approach to Blood DNA Screening for Cancer: Specificity Assessment (The NOMAD Study)
|
||
Completed |
NCT04122118 -
Pharmacist-led Transitions of Care in the Outpatient Oncology Infusion Center for Patients With Solid Tumor
|
N/A | |
Active, not recruiting |
NCT04940299 -
Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma
|
Phase 2 | |
Active, not recruiting |
NCT03168737 -
18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing Solid Tumors in Patients
|
Phase 1 | |
Active, not recruiting |
NCT06062901 -
An Educational Intervention on Provider Knowledge for the Support of Cancer Survivors
|
N/A | |
Active, not recruiting |
NCT02444741 -
Pembrolizumab and Stereotactic Body Radiation Therapy or Non-Stereotactic Wide-Field Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Terminated |
NCT04081298 -
eHealth Diet and Physical Activity Program for the Improvement of Health in Rural Latino Cancer Survivors
|
N/A | |
Active, not recruiting |
NCT04555837 -
Alisertib and Pembrolizumab for the Treatment of Patients With Rb-deficient Head and Neck Squamous Cell Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT04983901 -
PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN
|
Phase 2 | |
Active, not recruiting |
NCT04602026 -
The RIOT Trial: Re-Defining Frailty and Improving Outcomes With Prehabilitation for Pancreatic, Liver, or Gastric Cancer
|
N/A | |
Recruiting |
NCT04871542 -
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
|
||
Active, not recruiting |
NCT04592250 -
Financial Toxicity in Cancer Patients
|
||
Recruiting |
NCT05112614 -
Role of Gut Microbiome in Cancer Therapy
|
||
Active, not recruiting |
NCT04296305 -
Effect of Opioid Infusion Rate on Abuse Liability Potential of Intravenous Hydromorphone for Cancer Pain
|
Phase 4 | |
Recruiting |
NCT05873608 -
Communication Issues in Patient and Provider Discussions of Immunotherapy
|
N/A | |
Recruiting |
NCT02464696 -
Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure
|
N/A |