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Anti-tumor antibiotic
Mitoxantrone + G-CSF for Prostate Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by Hope Cancer Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cardiovascular: Must have adequate cardiac function (LVEF at least 40%)
No other malignancy except skin lesions that have been completely excised
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying giving mitoxantrone together with G-CSF to see how well it works in treating patients with metastatic prostate cancer.
Who is the study for?
This trial is for men with metastatic prostate cancer that hasn't improved with hormone therapy. They should have a life expectancy over 12 weeks, good heart and kidney function, no prior chemotherapy or extensive radiation, and no other cancers except certain skin lesions.Check my eligibility
What is being tested?
The study is testing the combination of mitoxantrone (a chemotherapy drug) and G-CSF (a growth factor to boost white blood cells) to see if it can better kill tumor cells in patients whose prostate cancer has spread and isn't responding to hormones.See study design
What are the potential side effects?
Mitoxantrone may cause side effects like nausea, low blood cell counts increasing infection risk, hair loss, mouth sores; G-CSF can cause bone pain, feverish feelings but usually helps reduce infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check βYesβ for the criteria belowSelect...
My heart's pumping ability is at least 40%.
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I have no cancer other than fully removed skin lesions.
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My prostate cancer is advanced, has spread, and does not respond to hormone therapy.
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My liver function tests are within normal limits.
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I can take care of myself and am up and about more than 50% of my waking hours.
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My creatinine level is below 1.5 mg/dL.
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?
Hope Cancer Institute, Inc.Lead Sponsor
3 Previous Clinical Trials
113 Total Patients Enrolled
Raj Sadasivan, MD, PhDStudy ChairHope Cancer Institute, Inc.
3 Previous Clinical Trials
113 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never received chemotherapy.I have been on hormone therapy for my condition for at least a month.My heart's pumping ability is at least 40%.I have no cancer other than fully removed skin lesions.My treatment plan does not specify biologic therapy.My prostate cancer is advanced, has spread, and does not respond to hormone therapy.My liver function tests are within normal limits.I can take care of myself and am up and about more than 50% of my waking hours.I am not currently undergoing radiotherapy and have not had extensive radiotherapy in the past.My creatinine level is below 1.5 mg/dL.I have not had any surgery before.My age is not a limiting factor for this trial.
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.
Is this research still taking on participants?
"According to information posted on clinicaltrials.gov, this trial has concluded its recruitment process and is no longer seeking participants. Initially published on March 1st 1997, the study had last been updated over six years ago in December 2013. Nonetheless, there are currently 1321 other trials searching for patients at this moment."
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