Personalized Cancer Vaccine in Egyptian Cancer Patients

NCT05059821 | Unknown Phase 1 DMC

• 1 other identifier: FMASU P109g/2019-2021
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate safety and immunogenicity of peptide cancer vaccine in patients with hepatocellular carcinoma (HCC) who developed recurrence after surgical resection and refractory to the available institutional standard of care lines of treatment .

Conditions

Hepatocellular Carcinoma

Keywords

Peptide vaccine, Heat shock protein 70, Monocytes

Outcome Measures

Primary Outcomes (2)

• Assessment of the safety of the personalized cancer vaccine

  Percentage of patients who developed adverse events (AEs)

  4 weeks

• Assessment of immunological response

  Percentage of change in CD20 +B-cells, CD16+CD56+NK cells,CD4 + cells,CD8+ cells,CD25+regulatory cells

  12 weeks

Secondary Outcomes (1)

• Progression free survival and overall survival time

  144 week

Study Arms (1)

Experimental Personalized Cancer Vaccine

EXPERIMENTAL

Patients with recurrent HCC after surgical resection and refractory to available line of treatment will receive Personalized peptide based vaccine with autologous heat shock protein 70 and autologous activated monocytes

Biological: Peptide cancer vaccine

Interventions

Peptide cancer vaccine BIOLOGICAL

Vaccine content are personalized peptides vaccine separated from each patients own tumor cells, autologous heat shock protein 70 separated from tumor cells and autologous activated monocytes that administered subcutaneously monthly for six months

Experimental Personalized Cancer Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who developed recurrence of HCC after surgical resection .
• Age ≥ 18 years.
• Eastern Cooperative Oncology Group performance status (ECOG) of 0-2 .
• Patient with radiologically or pathologically confirmed hepatocellular carcinoma.
• Patients who had been treated with surgical approach as per our (Ain Shams University) institute protocols and developed recurrence after surgery. They were either intolerant to the institute protocol of treatment or showed unresponsiveness of their disease after treatment.
• Child-Pugh class A or B .
• LAB values:
• Hemoglobin (≥ 8 g/dl), platelets (≥ 50,000/µl), leukocytes (≥ 2,500/µl), neutrophils (≥ 1,000/µl), lymphocytes (≥ 500/µl) Liver function: serum bilirubin (\< 3 x ULN), Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) (\< 5 x ULN) Renal function: serum creatinine (\< 1.5 x ULN)
• Patient has not received any antineoplastic chemotherapy, immunotherapy, or radiotherapy for the four weeks prior to the start of study treatment.
• Pregnancy test should be negative at the first dose of study treatment in fertile females. (Female patients who are not post-menopausal or surgically sterile should use a highly effective method of birth control from the date of signing the consent to the last follow up visit. Pregnancy test should be negative at the first dose of study treatment.)
• Written informed consent .

You may not qualify if:

• Patients receiving continuous systemic steroid treatment within the last 4 weeks prior to start of study treatment (The use of inhaled and nasally applied steroids, as well as topical steroids outside the vaccination area are permitted)
• Patients receiving systemic immunotherapy or immunosuppressant medication other than steroids within the last 4 weeks prior to start of study treatment.
• Patients with a history or evidence of systemic autoimmune disease.
• Active second malignancy or a prior malignancy within the past 12 months.
• Acute active infections requiring oral or intravenous antibiotics, antiviral or antifungal therapy within 1 week before the start of study treatment \[Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infections are permitted; direct-acting antivirals may be administered when medically indicated\].
• Any other acute medical condition that may compromise patient's safety or the activity of the studied vaccine treatment.
• Any other concurrent severe or uncontrolled chronic disease such as uncontrolled non-malignant liver, renal or lung disease, or decompensated cardiac failure or coronary insufficiency.
• Administration of a live, attenuated vaccine within 4 weeks before randomization
• Known previous major hypersensitivity reactions.
• History of human immunodeficiency virus (HIV)
• Evidence of current alcohol or drug abuse
• Women who are pregnant or who are breast feeding
• Medical or mental impairments that may limit participation in the study as judged by the investigators disease specialist.
• History of organ allograft.
• History of splenectomy.

Sponsors & Collaborators

• zeinab ahmed yousif hasan ashour: lead

Study Sites (1)

Faculty of Medicine Ain Shams Research Institute- Clinical Research Center (MASRI-CRC)

Cairo, 11566, Egypt

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Zeinab A Ashour, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeinab A Ashour, MD

CONTACT

01096056735; zeinabashour2012@yahoo.com

Mai A Aldeeb, MD

CONTACT

01020338896; Mael_deeb@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Internal Medicine, Allergy and clinical immunology unit

Model Details: Personalized peptide based vaccine with autologous heat shock protein 70 and autologous activated monocytes

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: September 28, 2021
• Study Start: April 19, 2021
• Primary Completion: April 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)