Study on the Safety and Effectiveness of ConvitVax Vaccine for Metastatic Breast Cancer

Sponsor: Jacinto Convit World Organization Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06023277

Provider View

This clinical trial is testing a new breast cancer vaccine called ConvitVax to see if it is safe and effective for women with metastatic breast cancer who have not responded to other treatments. The study is particularly aimed at helping women in developing countries who may not have access to modern cancer therapies.

Patient Parameters

Program Overview

This study is exploring a new breast cancer vaccine called ConvitVax, which is made from a patient's own tumor cells, a small amount of a bacteria called BCG, and a tiny bit of formalin. The vaccine is designed to be a low-cost and potentially effective treatment for women with metastatic breast cancer, except for those with cancer that has spread to the brain or spinal cord. The main goal is to see if the vaccine is safe and can be tolerated when given as an injection under the skin. The study will involve 40 women who have not had success with at least one other treatment. Participants will receive four doses of the vaccine, two weeks apart, and will be monitored for a year to see how they respond.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older.
  • Diagnosed with breast cancer that has spread and cannot be treated with surgery or radiation.
  • Cancer must be measurable with scans showing at least a 1 cm tumor.
  • Not pregnant or breastfeeding, and willing to use effective birth control.
  • Able to understand and sign consent forms.

Exclusion Criteria

  • Poor overall health or life expectancy less than 3 months.
  • Cancer that has spread to the brain or spinal cord, unless treated and stable.
  • Recent major surgery or unresolved side effects from previous treatments.
  • Use of high-dose steroids or other immune-suppressing drugs.
  • Poor blood, liver, or kidney function based on specific medical tests.
  • Other active cancers, except for certain skin or cervical cancers.
  • Known allergies to vaccine components or history of severe vaccine reactions.
  • Active infections, including HIV, hepatitis, or recent COVID-19.
  • Autoimmune diseases requiring treatment.
  • Participation in another clinical trial or recent live vaccine.
  • Previous organ transplant or splenectomy.
  • Institutionalized individuals or those unable to comply with study requirements.

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