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Chemotherapy
Monoclonal Antibody + Chemotherapy and Stem Cell Transplant for Prostate 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
Hepatic: Bilirubin no greater than 1.3 mg/dL
Renal: Creatinine less than 1.5 mg/dL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying giving monoclonal antibody therapy and chemotherapy drugs together followed by a stem cell transplant in patients with prostate cancer that has spread.
Who is the study for?
This trial is for adults with metastatic prostate cancer that hasn't improved with hormone therapy. They should have a good performance status, adequate bone marrow function, normal liver and kidney tests, and no severe heart or lung conditions. Patients must not have had certain prior treatments like radiotherapy to most of the skeleton or recent chemotherapy.Check my eligibility
What is being tested?
The study is testing if combining monoclonal antibody therapy with chemotherapy followed by peripheral stem cell transplantation can effectively treat metastatic prostate cancer resistant to hormone therapy. It's in Phase I to determine the treatment's safety and effectiveness.See study design
What are the potential side effects?
Potential side effects may include reactions specific to monoclonal antibodies such as allergic responses, plus typical chemotherapy-related issues like fatigue, nausea, hair loss, increased risk of infection due to low blood counts, and possible organ damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My bilirubin level is 1.3 mg/dL or lower.
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My creatinine level is below 1.5 mg/dL.
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My heart's pumping ability is normal or above.
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My blood clots normally.
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My lung function (FEV1) is at least 65% of what's expected.
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My prostate cancer has spread to less than 25% of my bone marrow.
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I am mostly able to care for myself and carry out daily activities.
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My prostate cancer is advanced and does not respond to hormone therapy.
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I am 18 years old or older.
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
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Who is running the clinical trial?
University of California, DavisLead Sponsor
911 Previous Clinical Trials
4,709,583 Total Patients Enrolled
13 Trials studying Prostate Cancer
1,829 Patients Enrolled for Prostate Cancer
Carol M. Richman, MDStudy ChairUniversity of California, Davis
2 Previous Clinical Trials
8 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bilirubin level is 1.3 mg/dL or lower.My creatinine level is below 1.5 mg/dL.My prostate cancer has spread to less than 25% of my bone marrow.I am mostly able to care for myself and carry out daily activities.My heart's pumping ability is normal or above.My blood clots normally.My lung function (FEV1) is at least 65% of what's expected.I have not received any treatments derived from mouse proteins.It has been over 4 weeks since my last standard dose of chemotherapy.My condition requires hormone therapy.I am not currently receiving regular blood transfusions.I underwent hormone therapy for my condition over 3 months ago.I am not taking any blood thinners, except low dose coumadin for a central line.My prostate cancer is advanced and does not respond to hormone therapy.There is no requirement for a specific life expectancy.I have not had radiation on more than 25% of my bones.I am 18 years old or older.My condition requires surgery as specified in the disease characteristics.It has been over 4 weeks since my last external beam radiotherapy.
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.
How does the risk-benefit profile of this therapy compare to other treatments?
"Our analysis at Power gives this therapeutic intervention a rating of 1, as it is currently undergoing its initial clinical testing phase and has limited evidence for both safety and efficacy."
Answered by AI
Is the opportunity to participate in this trial available right now?
"This research, which was initially made available on March 1st 2001 and had its most recent updates on September 19th 2013, is not presently accepting participants. However, 1321 other medical trials are currently open for enrolment."
Answered by AI
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