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Alkylating agent
Combination Chemotherapy for Solid Cancers
Phase 1
Waitlist Available
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically proven refractory solid tumor for which paclitaxel and cisplatin are reasonable therapeutic options
At least 4 weeks since other prior chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying how well combining fenretinide, paclitaxel, and cisplatin works in treating patients with solid tumors that have not responded to previous therapy.
Who is the study for?
Adults with solid tumors that haven't improved after previous treatments can join this trial. They must have a certain level of blood cells, liver and kidney function, no serious heart issues or infections, and not be pregnant. Participants should use birth control before, during, and after the study.Check my eligibility
What is being tested?
The trial is testing how well a combination of three chemotherapy drugs—fenretinide, paclitaxel, and cisplatin—works to treat solid tumors. It's in Phase I to see if the drug mix is effective when other treatments have failed.See study design
What are the potential side effects?
Chemotherapy drugs like fenretinide, paclitaxel, and cisplatin may cause side effects such as nausea, fatigue, hair loss, nerve damage leading to numbness or tingling sensations (neuropathy), increased risk of infection due to low blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is resistant to treatment and paclitaxel or cisplatin could be treatment options.
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It has been over 4 weeks since my last chemotherapy session.
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I do not have severe heart problems.
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I do not have any infections that aren't responding to treatment.
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I can take care of myself and am up and about more than half of the day.
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I am 18 years old or older.
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I haven't had radiation on more than a quarter of my bone marrow.
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?
Ohio State University Comprehensive Cancer CenterLead Sponsor
316 Previous Clinical Trials
289,686 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,646 Total Patients Enrolled
Gregory A. Otterson, MDStudy ChairOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
63 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any active brain or spinal cord diseases.My cancer is resistant to treatment and paclitaxel or cisplatin could be treatment options.It has been over 4 weeks since my last chemotherapy session.It's been over 2 weeks since my last surgery and I've recovered.I haven't taken high doses of vitamin A or beta carotene in the last 4 weeks.I have not been treated with paclitaxel, cisplatin, or fenretinide.I have cancer spread to the brain but have finished and recovered from one brain radiotherapy course.I will use effective birth control before, during, and for 2 months after the study.It's been over 4 weeks since my last radiotherapy on the only measurable cancer site.I don't have any major health or mental conditions that would increase my risk.I haven't had any cancer except for skin cancer or cervical pre-cancer in the last 5 years.I do not have severe heart problems.I don't have any major health or mental conditions that would increase my risk.I do not have any infections that aren't responding to treatment.I can take care of myself and am up and about more than half of the day.I am 18 years old or older.I haven't had radiation on more than a quarter of my bone marrow.
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 it still possible to join this clinical experiment?
"According to clinicaltrials.gov, this research initiative is not currently enrolling participants at the moment; it was initially posted on January 1st 2001 and last updated 14th May 2013. Nevertheless, there are presently 2,409 other medical studies that welcome new candidates."
Answered by AI
Has the FDA provided authorisation for this therapeutic approach?
"The safety of this experimental therapy has been tentatively rated a 1, considering that it is only in the initial stages of testing and minimal evidence exists to validate its efficacy."
Answered by AI
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