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Cancer Vaccine

ConvitVax for Breast Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Jacinto Convit World Organization Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically- or cytologically-confirmed diagnosis of adenocarcinoma of the breast

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial is testing a low cost, personalized immunotherapy for women with metastatic breast cancer who have failed other treatments. It will be tested on 40 women at a single center in Venezuela.

Who is the study for?

This trial is for women over 18 with metastatic breast cancer who have failed at least one standard treatment. They must not be pregnant or breastfeeding and agree to use effective contraception. Patients should not have brain metastases, severe liver or blood issues, an ECOG performance status of ≥1, life expectancy under 3 months, active infections, certain other cancers within the last 3 years, known HIV/AIDS or hepatitis A/B/C infection.Check my eligibility

What is being tested?

ConvitVax is being tested as a potential vaccine for advanced breast cancer. It's made from the patient's own tumor cells mixed with BCG (a tuberculosis vaccine) and formalin. The study involves giving patients four doses via skin injection every two weeks and monitoring them for a year.See study design

What are the potential side effects?

Potential side effects may include typical reactions to vaccines such as local skin reactions at the injection site, fever, fatigue and allergic responses. Since it includes BCG used in TB vaccination, there might also be flu-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My breast cancer diagnosis was confirmed through tissue analysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Criteria for disease recurrence

Secondary outcome measures

Antitumor effect

Trial Design

1Treatment groups

Experimental Treatment

Group I: ConvitVaxExperimental Treatment1 Intervention

ConvitVax is a vaccine made of three components: autologous tumor cells homogenate obtained from 0.3 g of tumor tissue, 0.0625 mg of BCG D1331, and 0.02% of formalin. There is no dose escalation in this study. Four doses of 0.5 mL of ConvitVax will be applied via id injection with a 2-week interval between each dose.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Jacinto Convit World Organization Inc.Lead Sponsor

Fundación Jacinto ConvitUNKNOWN

Instituto Oncologico Luis RazettiOTHER

1 Previous Clinical Trials

329 Total Patients Enrolled

Frequently Asked Questions

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

Are there still openings available for prospective participants in this experiment?

"This particular research endeavour is not currently accepting patients, despite being initially posted on April 1st 2024 and last updated on August 28th 2023. However, there are 2415 other clinical trials seeking participants at the present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of ConvitVax in Metastatic Breast Cancer

2024. "A Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of ConvitVax in Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06023277.