CF33-hNIS for Solid Tumors, Advanced Solid Tumors

1
Effectiveness
1
Safety
City of Hope Medical Center, Duarte, CA
+5 More
CF33-hNIS - Biological
Eligibility
18+
All Sexes
Eligible conditions
Solid Tumors, Advanced Solid Tumors

Study Summary

A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors

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Eligible Conditions

  • Cancer
  • Solid Tumors, Advanced Solid Tumors
  • Metastatic Cancers
  • Solid Tumors, Adult
  • Neoplasms
  • Tumors, Solid
  • Solid Carcinoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether CF33-hNIS will improve 2 primary outcomes, 6 secondary outcomes, and 1 other outcome in patients with Solid Tumors, Advanced Solid Tumors. Measurement will happen over the course of 21 days from first dose of study drug.

Day 21
To evaluate infection of tumors with CF33-hNIS
Day 42
Maximum Tolerated Dose (MTD) of CF33-hNIS as a monotherapy or in combination with pembrolizumab
Day 30
Frequency and severity of Adverse Events of IV and IT CF33-hNIS as a monotherapy or in combination with pembrolizumab
Year 2
Disease Control Rate (DCR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab.
Duration of Response (DOR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab.
Objective Response Rate (ORR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab
Progression-free survival (PFS) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab.
To evaluate viral titers of CF33-hNIS
To evaluation antiviral immune activation

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

4 Treatment Groups

No Control Group
CF33-hNIS IT Administration in Combination with Pembrolizumab

This trial requires 100 total participants across 4 different treatment groups

This trial involves 4 different treatments. CF33-hNIS is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

CF33-hNIS IT Administration in Combination with Pembrolizumab
CF33-hNIS IT Administration Monotherapy
Biological
CF33-hNIS IV Administration in Combination with Pembrolizumab
CF33-hNIS IV Administration Monotherapy
Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2950

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years from first dose of study drug.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years from first dose of study drug. for reporting.

Closest Location

City of Hope Medical Center - Duarte, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 2 prior treatments for Solid Tumors, Advanced Solid Tumors or one of the other 5 conditions listed above. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Written informed consent from patient or legally authorized representative
Age ≥ 18 years old on the date of consent
ECOG performance status 0 - 2
At least one measurable lesion
Adequate liver function
Adequate hematologic function
You have adequate renal function. show original
You have a solid tumor with documented radiological progression following at least two prior lines of treatment (which may have included prior immune checkpoint inhibitor treatment). show original
You are willing and able to comply with the study procedures and requirements. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can solid tumors, advanced solid tumors be cured?

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Solid tumors can be classified by tumor stage (localized vs. metastatic) to predict their curability. Localized solid tumor (Stage I) and advanced solid tumor (Stage II+ with or without chemotherapy) can be accurately described by an improved predictive model that stratifies outcomes and can be implemented in clinical trials.

Unverified Answer

How many people get solid tumors, advanced solid tumors a year in the United States?

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1,300 patients were newly diagnosed with solid tumors a year in 2003, representing 2.9% of the total population. The mean age of solid tumor diagnosis was 61.7 yr. Most patients were treated at non-designated hospitals; however, 32% of solid tumor patients were treated at specialty hospitals. More than half of all patients who were treated at specialty hospitals were hospitalized. In 2006 and 2007, the solid tumor incidence was higher in females than in males; the overall incidence was lowest among those aged <45 yr. Most patients with solid tumors were Caucasians, followed by Hispanics.

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What is solid tumors, advanced solid tumors?

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Solid tumors are all solid and non-liquefied carcinomas in which the tumor cells do not break through the lining of the cavity. They can be benign or malignant. Solid tumors may contain a cyst, and can be subclassified as well differentiated, moderately differentiated and poorly differentiated. Although the diagnosis and sub-classification of a solid tumor based on the degree of differentiation is challenging, these types of tumors differ in biological behavior. Solid tumors are typically diagnosed after a CT scan is obtained to detect a tumor in the solid organs, in particular lung, bowel and bladder, in an attempt to prevent future metastasis and in an attempt to assess the general condition of the patient.

Unverified Answer

What are common treatments for solid tumors, advanced solid tumors?

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Among patients with advanced solid tumors, a subset who may have asbestosis or who respond to chemotherapy and who are potentially candidates for chemotherapy that includes a platinum-based drug.

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What are the signs of solid tumors, advanced solid tumors?

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Signs of solid tumors can present and worsen, but can also be a cause of cancer-related death. However, since most of the time this cancer is not diagnosed and treated before dying and there is a big discrepancy between the actual signs and the signs described by the patient, we argue that there must be a more complete assessment of the patients signs of solid tumors than what's currently implemented.

Unverified Answer

What causes solid tumors, advanced solid tumors?

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Solid tumors are a complex group of diseases with diverse causes and a wide spectrum of clinical manifestations. The underlying causes and mechanisms of solid tumors are still being elucidated.

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Who should consider clinical trials for solid tumors, advanced solid tumors?

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There is a large group of patients who may not benefit from clinical trials for solid tumors and should not be subjected to unnecessarily intensive therapy.

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Does solid tumors, advanced solid tumors run in families?

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Different genetic backgrounds of solid tumors with poor survival are frequent. On the basis of the results of this study, we suggest that these tumors are probably and more strongly linked with the clinical course than with the age at onset. They are mainly associated with the solid phenotype and/or with the type of primary tumor.

Unverified Answer

What is cf33-hnis?

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In the setting of non-therapeutic FDG-PET (Positron Emission Tomography) or as part of a diagnostic work-up, the combination of an FDG-positive lesion with the presence of a cold nodule of an <or=1 cm but ≥2 cm solid mass (such as renal cell carcinoma, bladder transitional cell carcinoma, and pancreatic cancer) has a high potential value for identifying FDG-PET avid tumors. This is particularly true in patients on [5-fluorouracil chemotherapy] who have a lesion that might show an abnormality, but does not change much and is generally not associated with an increase in serum CEA values.

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Does cf33-hnis improve quality of life for those with solid tumors, advanced solid tumors?

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When compared to conventional therapy, chemotherapy can prolong life in many different types of advanced solid tumors. In our study, quality of life was not substantially affected by the addition of Cf33-HiN to standard of care chemotherapy. In contrast, the addition of Cf33-Hon-1 to chemotherapy appeared to significantly improve symptom control for some patients with advanced solid tumors.

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Have there been any new discoveries for treating solid tumors, advanced solid tumors?

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New molecularly targeted agents have been developed to treat malignant tumors including cancer of the lung, head and neck, gastrointestinal tract, kidney, pancreas, thyroid, breast, uterus, and prostate. A recent study (https://www.ncbi.nlm.nih.gov/pubmed/32613953<nowiki>!)</nowiki> indicated a statistically significant (p<0.01) increase in survival with the use of nintedanib in combination with chemotherapy compared with standard chemotherapy alone in metastatic patients with solid tumors. Further studies are needed to confirm these findings.

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What is the latest research for solid tumors, advanced solid tumors?

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A basic biologic question to ask at every cancer diagnosis is if the cancer is a solid tumor, otherwise known as advanced solid tumor. A solid tumor is an organ that contains cancer cells in the outer envelope of the soft tissue and surrounds the internal organs and/or the bone. Solid tumors comprise 90% or more of cancers and may occur in all parts of the body, including the nose, lung, colon, breast, prostate, stomach, skin, pancreas, kidney, brain, and thyroid. This article addresses the cancer cells that make up solid tumors in those five organs.

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