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Monoclonal Antibodies

Monoclonal Antibody + Stem Cell Transplant for Breast Cancer

Phase 1

Waitlist Available

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

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

Must have

Must have either relapsed or failed to achieve complete remission after combination chemotherapy with or without stem cell or marrow transplantation

No CNS disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying how well giving radiolabeled monoclonal antibody, cyclosporine, and peripheral stem cell transplantation works in treating patients with breast cancer that has spread to other parts of the body.

Who is the study for?

This trial is for adults aged 18-55 with metastatic breast cancer that hasn't improved after previous treatments. Participants must have proper kidney and liver function, not be pregnant or nursing, use contraception if fertile, have a good performance status, and no history of severe reactions to monoclonal antibodies. They should not have central nervous system disease or significant lung involvement by the cancer.Check my eligibility

What is being tested?

The study tests a combination of radiolabeled monoclonal antibody therapy with cyclosporine (to prevent immune response against normal tissues) and peripheral stem cell transplantation (to allow higher doses of chemotherapy). The goal is to target tumor cells more precisely while sparing healthy ones.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to the monoclonal antibody, organ inflammation due to radiation exposure, complications from high-dose chemotherapy such as infections or blood disorders, and side effects related to cyclosporine like kidney damage or increased risk of other cancers.

Eligibility Criteria

Inclusion Criteria

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

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My cancer returned or didn't fully respond after chemotherapy and possibly a transplant.

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I do not have cancer that has spread to my brain or spinal cord.

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I am mostly able to care for myself and carry out daily activities.

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My blood oxygen and carbon dioxide levels are normal for my age and sex.

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My breast cancer has spread and does not respond to treatment.

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Less than 25% of my liver is affected by cancer.

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Less than 25% of my lung is affected by cancer spread.

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I am between 18 and 55 years old.

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I can have needles inserted without difficulty.

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I have no cancer other than treated skin cancer or cervical cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor

911 Previous Clinical Trials

4,709,565 Total Patients Enrolled

15 Trials studying Breast Cancer

1,342,963 Patients Enrolled for Breast Cancer

Sally DeNardo, MDStudy ChairUniversity of California, Davis

Media Library

Radiolabeled Monoclonal Antibody (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT00003920 — Phase 1

Breast Cancer Clinical Trial 2023: Radiolabeled Monoclonal Antibody Highlights & Side Effects. Trial Name: NCT00003920 — Phase 1

Radiolabeled Monoclonal Antibody (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00003920 — Phase 1

Frequently Asked Questions

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

Can I register for participation in this experiment?

"This trial is seeking 18 individuals between ages of 18 and 55 with a metastatic form of breast cancer, who have either relapsed or not achieved complete remission after chemotherapy. The prerequisites for eligibility include being HAMA negative; having absolute granulocyte count at least 2000/mm3, platelet count at least 150,000/mm3 and corrected diffusing capacity at least 60%; and no concurrent radiotherapy or systemic biologic therapy. Furthermore, prospective participants must possess arterial blood gases within normal limits for age & sex; LVEF ≥50% by MUGA; FEV1 & FVC ≥65% predicted"

Answered by AI

Are there any openings available for participants in this trial?

"The data on clinicaltrials.gov affirms that this study is not presently recruiting participants, as the trial was initially posted in April 1996 and last updated over 5 years ago. However, 2600 other trials are actively enrolling patients at this time."

Answered by AI

Has this medication obtained governmental sanction?

"We rate this treatment's safety as a 1, since it is currently in its earliest phase of testing and there are limited data points available that confirm efficacy or safety."

Answered by AI

Is there an age limit to partake in this trial?

"According to the prerequisites, only individuals aged between 18 and 55 are eligible for enrollment in this trial. Nevertheless, there exist 74 trials specifically targeting those under 18 and 2505 studies open to people over 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Monoclonal Antibody Therapy Plus Cyclosporine and Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Breast Cancer

1996. "Monoclonal Antibody Therapy Plus Cyclosporine and Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00003920.

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