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Growth Factor
Biological Therapy + Stem Cell Transplant for Advanced Breast Cancer
Phase 1
Waitlist Available
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min
CT or MRI required unless asymptomatic and no history of brain metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will combine interleukin-2 with filgrastim to stimulate cell production in treating patients with stage IIIB, stage IV, metastatic, or recurrent breast cancer who will undergo peripheral stem cell transplantation.
Who is the study for?
This trial is for patients under 65 with advanced breast cancer (stage IIIB, IV, metastatic or recurrent) that's stable or responding to chemotherapy. They shouldn't have large pleural effusions, active infections, brain metastases, recent major surgery/chemo/radiotherapy without recovery, certain other cancers within 2 years except some skin cancers and cervical carcinoma in situ. Good performance status required.Check my eligibility
What is being tested?
The trial tests the effectiveness of interleukin-2 combined with filgrastim to stimulate cell production in patients undergoing peripheral stem cell transplantation as a treatment for advanced breast cancer.See study design
What are the potential side effects?
Potential side effects may include immune system reactions like fever and chills, fatigue due to anemia from bone marrow suppression by chemotherapy used before transplantation; risk of infection post-transplantation; and possible organ inflammation caused by interleukin-2.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is good, with creatinine levels at or below 1.5 mg/dL or clearance above 60 mL/min.
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I haven't had a CT or MRI because I have no symptoms and no history of brain cancer spread.
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My advanced breast cancer is not part of, or I refuse to join, a phase III SWOG study.
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I do not have any active cancer spread to my brain.
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My breast cancer is advanced, affecting the chest wall, lymph nodes, or has spread.
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My lung function tests show I breathe well enough.
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My cancer is not getting worse with chemotherapy.
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I do not have a large fluid buildup in my chest causing symptoms.
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I am younger than 65 years old.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My liver tests are within normal limits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Find a Location
Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
602 Previous Clinical Trials
1,558,475 Total Patients Enrolled
10 Trials studying Breast Cancer
1,342,320 Patients Enrolled for Breast Cancer
Jeffrey A. Sosman, MDStudy ChairVanderbilt-Ingram Cancer Center
5 Previous Clinical Trials
174 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition meets the chemotherapy guidelines listed.It's been over 4 weeks since my last chemotherapy and I've recovered.My kidney function is good, with creatinine levels at or below 1.5 mg/dL or clearance above 60 mL/min.I haven't had a CT or MRI because I have no symptoms and no history of brain cancer spread.I am not currently on hormone therapy.My advanced breast cancer is not part of, or I refuse to join, a phase III SWOG study.My heart is strong, with no recent heart attacks or severe chest pain.I do not have any active cancer spread to my brain.I have had 2 or fewer chemotherapy treatments for my advanced cancer.My breast cancer is advanced, affecting the chest wall, lymph nodes, or has spread.My lung function tests show I breathe well enough.It's been over 3 weeks since my major surgery and I've recovered.My cancer can be measured or seen on tests, or I've had treatment for stage IV cancer that can't be evaluated.I don't have a history of bladder bleeding, infections, brain disorders, HIV, recent cancers except some skin or cervical types, and I'm not pregnant or nursing.My treatment plan does not include biologic therapy.My cancer is not getting worse with chemotherapy.I do not have a large fluid buildup in my chest causing symptoms.I am younger than 65 years old.It's been over 2 weeks since my last radiotherapy session and I've recovered.I am fully active or restricted in physically strenuous activity but can do light work.I have never been treated with mitomycin or nitrosourea.I have received less than 350 mg/m² of doxorubicin in my lifetime.My liver tests are within normal limits.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has this particular treatment been subject to the necessary regulatory scrutiny?
"Due to the limited amount of clinical data supporting safety and efficacy, this treatment is rated a 1 on our team's scale."
Answered by AI
Are individuals still able to participate in this clinical experiment?
"As depicted on clinicaltrials.gov, this investigation is no longer looking for volunteers; it was first posted in February 1995 and the most recent update came with September 2013. However, 2600 other trials are currently recruiting patients."
Answered by AI
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