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Cytokine

Interleukin-12 for Breast Cancer

Phase 1

Waitlist Available

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

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

Must have

Enrollment in protocol for high dose chemotherapy with stem cell rescue using the 'STAMP V' regimen (cyclophosphamide, thiotepa, and carboplatin)

Age: 18 to 60

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying how well interleukin-12 works in treating women with metastatic breast cancer.

Who is the study for?

This trial is for women with stage IV breast cancer who've had high-dose chemo and stem cell transplant. They must be on the 'STAMP V' regimen, not have severe liver or kidney issues, infections needing IV antibiotics, brain metastases, significant heart disease, or be pregnant. Women aged 18-60 who are using effective contraception can join.Check my eligibility

What is being tested?

The study tests Interleukin-12's effectiveness in treating metastatic breast cancer post high-dose chemotherapy and stem cell transplantation. It aims to see if this treatment can stop tumor blood flow and boost white blood cells to fight cancer.See study design

What are the potential side effects?

Interleukin-12 may cause side effects such as immune system reactions that could lead to inflammation in various organs, potential impact on blood counts leading to increased infection risk, fatigue, nausea, and possibly allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am enrolled in a treatment plan that includes high dose chemotherapy with stem cell support.

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I am between 18 and 60 years old.

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I am female.

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I am mostly self-sufficient and active.

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My heart pumps well and I don't have serious heart conditions.

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My breast cancer is at stage IV, either found as such or after a recurrence.

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I do not have any significant autoimmune diseases.

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My liver function tests are within the required limits.

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My lung function tests are above 50% of the predicted value.

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I do not have severe nerve damage or brain/spinal cord disease.

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I do not have any infections needing IV antibiotics.

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My kidney function is good, with creatinine levels below 1.8 mg/dL and clearance above 60 mL/min.

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I don't have ongoing stomach ulcers or serious GI bleeding.

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I have never had inflammatory bowel disease.

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My cancer has not spread to my brain or central nervous system.

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I do not have any serious illnesses besides my current condition.

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 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor

837 Previous Clinical Trials

13,010,237 Total Patients Enrolled

47 Trials studying Breast Cancer

7,230 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,667 Previous Clinical Trials

40,926,131 Total Patients Enrolled

939 Trials studying Breast Cancer

1,543,325 Patients Enrolled for Breast Cancer

David Avigan, MDStudy ChairBeth Israel Deaconess Medical Center

14 Previous Clinical Trials

424 Total Patients Enrolled

2 Trials studying Breast Cancer

8 Patients Enrolled for Breast Cancer

Media Library

Interleukin-12 (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT00003412 — Phase 1

Breast Cancer Clinical Trial 2023: Interleukin-12 Highlights & Side Effects. Trial Name: NCT00003412 — Phase 1

Interleukin-12 (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00003412 — Phase 1

Frequently Asked Questions

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

Does this experimental treatment have an age limit?

"Based on the rules that potential participants must meet, the minimum age for this trial is 18 while the maximum age is 60."

Answered by AI

Are there any slots left for this research project?

"This particular clinical trial is not currently recruiting patients. Based on the information available on clinicaltrials.gov, the last time this trial was updated was September 16th, 2013. It is 2683 other clinical trials are currently looking for patients."

Answered by AI