Your session is about to expire
← Back to Search
PEN-866 + Chemotherapy for Sarcoma
Study Summary
This trial is studying the combination of 3 drugs to see if it can be used to treat adolescents and young adults with solid tumors, Ewing sarcoma, or rhabdomyosarcoma that returned after or did not respond to standard treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I have confirmed recurrent or refractory Ewing sarcoma or rhabdomyosarcoma.I have had multiple treatments for my condition.I am not taking any medications that interfere with specific body enzymes or transporters.You are currently pregnant or breastfeeding.My cancer diagnosis or relapse has been confirmed with a tissue sample.For phase 2, you must have a disease that can be measured by a specific standard.I have a confirmed diagnosis of Ewing sarcoma or rhabdomyosarcoma that has come back or did not respond to treatment.I have a confirmed solid tumor that has come back or didn't respond to treatment, but it's not in my brain or lymph nodes.I can take care of myself but might not be able to do any heavy work.I have recovered from the major side effects of my previous cancer treatments.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.I have chronic hepatitis B but my viral load is undetectable due to ongoing treatment.My cancer has spread to my bone marrow, affecting my blood counts.I have not had major surgery in the last 28 days.Side effects from my previous treatments are mild, except for nerve issues and hair loss.I stopped taking vincristine, temozolomide, or irinotecan due to severe side effects.My Ewing sarcoma has a specific genetic change.I am willing to have a tumor biopsy and I am 18 or older.I am between 12-17 years old and can have a biopsy with little risk.I have had multiple treatments for my condition.I have had severe nerve damage or constipation from vincristine.I haven't had treatment with both irinotecan and temozolomide together.I have had treatment for brain metastases.I can provide a tissue sample or slides of my tumor for testing.I had hepatitis C but it's either cured or currently undetectable.I am eligible for new treatments after a certain time since my last therapy.It's been over 3 weeks since my last chemotherapy that affects my bone marrow.I have recovered from the side effects of my previous cancer treatments.It's been over a week since my last non-myelosuppressive cancer treatment.My cancer can be seen on scans or has signs like high tumor markers.I do not have any unmanaged ongoing illnesses.My genetic test shows I have the UGT1A1 28/28 genotype.I have a confirmed solid tumor that has come back or did not respond to treatment, excluding brain tumors and lymphoma.I am between 12 and 39 years old.My cancer can be seen on scans or confirmed through tests.I am willing to have a central line placed if I don't already have one.My organs and bone marrow are working well.I am not currently taking any experimental drugs or other cancer treatments.I have new or worsening brain metastases or leptomeningeal disease.I have not been treated with both irinotecan and temozolomide together before.You have had allergic reactions to drugs with similar ingredients as PEN-866 or other drugs used in the study.
- Group 1: 1/Dose Escalation
- Group 2: 2/MTD/RP2D
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What is the ultimate aim of this research endeavor?
"This clinical trial, to be monitored between baseline and 18 cycles, chiefly seeks to determine the objective response rate. Secondary objectives include determining duration of response, analyzing plasma and tumor pharmacokinetics of PEN-866 in combination with vincristine and temozolomide, as well as comparing levels of phospho-gamma-H2AX immunofluorescence in pre-treatment samples against those taken after treatment."
What type of individuals is this research endeavor targeting?
"This clinical trial is seeking 64 individuals with rhabdomyosarcoma between 12 and 39 years of age. Those hoping to join the study must meet a variety of criteria, such as having measurable (or non-measurable) disease on imaging for Phase 1 or histologically confirmed recurrent/refractory solid tumors for Phase 2. Additionally, participants should have recovered from any acute side effects sustained from prior treatments; cytotoxic chemotherapy requires 21 days before enrollment while other anti-cancer agents not known to be myelosuppressive necessitate 7 days."
To what maladies is PEN-866 predominantly employed?
"The pharmaceutical PEN-866 is usually prescribed to combat acquired immunodeficiency syndrome, although it has been found useful in treating conditions like advanced thymoma and small cell lung cancer (sclc), as well as lymphoma Hodgkins."
What is the current size of this research endeavor?
"This trial is no longer enrolling new patients as the data posted on clinicaltrials.gov was last edited on November 25th, 2022. However, if you are seeking medical studies for rhabdomyosarcoma or PEN-866 there are currently 470 and 429 trials respectively that are still recruiting volunteers."
Could you provide an overview of any past experiments involving PEN-866?
"Currently, there are 429 active clinical trials for PEN-866; 110 of which have entered Phase 3. The majority of the studies originated in New york City though they can now be found at 18884 sites across the world."
Does this research encompass elderly individuals aged 75 and up?
"This clinical trial has set a minimum age of 12 years old and an upper limit of 39 to be eligible for participation."
Is enrollment in this trial still an option for prospective participants?
"This trial is no longer accepting patients. Originally posted on December 1st 2022, it was last edited on November 25th of the same year. There are presently 470 trials in progress looking for rhabdomyosarcoma subjects and 429 studies that require participants to take PEN-866."
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger