BridgeMD
Tests treatment safety and results for Sarcoma
Official title Phase 1/2 Trial to Evaluate the Safety and Efficacy of PEEL-224 in Combination With Vincristine and Temozolomide in Adolescents and Young Adults With Relapsed or Refractory Sarcomas
ClinicalTrials.gov ID: NCT06709495
What this study is testing
What is PEEL-224?
PEEL-224 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This research is being done to test a new drug called PEEL-224 in combination with two commercially available drugs, Vincristine and Temozolomide, and to determine how effective this combination of drugs is at treating Ewing Sarcoma (EWS) and Desmoplastic Small Round Cell Tumor (DSRCT), as well as multiple other kinds of sarcomas. The names of the study drugs and biological agents involved in this study are: PEEL-224 (a type of Topoisomerase 1 inhibitor) Vincristine (A type of vinca alkaloid) Temozolomide (A type of alkylating agent) Pegfilgrastim or Filgrastim (types of Myeloid growth factors)
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 year
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 49
You may be able to join if
- -Patients in all cohorts must have relapsed or refractory disease after standard therapy. Phase 1 (only) diagnosis requirements: -Patients must have:
- Evaluable or measurable disease; and
- Histologic diagnosis of sarcoma Phase 2 (only) diagnosis requirements
- EWS cohort: Patients must have:
- RECIST measurable disease at study entry;
You likely can't join if
- Patients who have received prior treatment with PEEL-224.
- Patients who have had progressive disease while receiving irinotecan and temozolomide in combination will be excluded from the Phase 2 EWS and DSRCT...
- Participants who are receiving any other anti-cancer agents for this condition.
- Patients receiving strong P450 CYP1A2 and CYP3A4 inhibitors and/or inducers with 14 days of the first planned dose of PEEL-224. NOTE: levofloxacin is...
- Patients who have received a solid organ or allogeneic stem cell transplant
- Pregnant participants, given that the effects of PEEL-224 on the developing human fetus are unknown.
See the full eligibility criteria
Who can join
- -Patients in all cohorts must have relapsed or refractory disease after standard therapy. Phase 1 (only) diagnosis requirements: -Patients must have:
- Evaluable or measurable disease; and
- Histologic diagnosis of sarcoma Phase 2 (only) diagnosis requirements
- EWS cohort: Patients must have:
- RECIST measurable disease at study entry;
- Histologic diagnosis consistent with Ewing sarcoma; and
- Molecular evidence of a FET-ETS family translocation including but not limited to any of the following:
- EWSR1::FLI1, EWSR1::ERG, EWSR1::ETV1, EWSR1::ETV4, EWSR1::FEV, FUS::FLI1, FUS::ERG
- DSRCT cohort: Patients must have:
- RECIST measurable disease at study entry;
- Histologic diagnosis consistent with DSRCT; and
- Molecular evidence of an EWSR1::WT1 fusion
- Other sarcoma cohort: Patients must have:
- RECIST evaluable or measurable disease; and
- Histologic diagnosis of sarcoma. Patients with EWS or DSRCT with evaluable but not measurable disease may participate in this cohort.
- Slots in this cohort will include three dedicated slots for patients with rhabdomyosarcoma, three dedicated slots for patients with osteosarcoma and three dedicated slots for patients with other translocation-associated...
- Age: ≥ 12 years and ≤ 49 years.
- Weight: Patients must be ≥ 40 kg.
- Performance Status: Karnofsky ≥ 50% for patients \>16 year of age and Lansky ≥ 50% for patients ≤ 16 years of age. (see Appendix A for definitions of Lansky and Karnofsky Performance Status).
- Participants must meet the following organ and marrow function as defined below: Adequate Bone Marrow Function:
- Hematologic Requirements for people without Bone Marrow Involvement by Disease:
- Absolute neutrophil count (ANC) ≥ 1,000/uL
- Platelet count ≥100,000/uL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) --Hematologic Requirements for people with Bone Marrow Involvement by Disease:
- ANC ≥750 /uL
- Platelets ≥50,000 /uL (may receive platelet transfusions) Not known to be refractory to red cell and/or platelet transfusions. --Adequate Renal Function: Creatinine clearance or radioisotope GFR ≥70ml/min/1.73 m2 or A...
- Age: 12 to \< 13 years, Maximum Serum Creatinine (mg/dL): Male 1.2, Female 1.2
- Age 13 to \< 16 years, Maximum Serum Creatinine (mg/dL): Male 1.5, Female 1.4 ---≥ 16 years, Maximum Serum Creatinine (mg/dL): Male 1.7, Female 1.4 --Adequate Liver Function:
- Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x upper limit of normal (ULN) for age
- SGPT (ALT) ≤110 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L.
- Adequate Cardiac Function: QTc \< 480 msec -Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy except organ function as noted above. Patients must meet the following minimum...
- Myelosuppressive chemotherapy: At least 14 days after the last dose of myelosuppressive chemotherapy
- Radiotherapy:
- At least 14 days after local XRT (small port, including cranial radiation);
- At least 90 days must have elapsed after prior TBI, craniospinal XRT or if \>50% radiation of pelvis;
- At least 42 days must have elapsed if other substantial BM radiation.
- Small molecule biologic therapy: At least 7 days following the last dose of a biologic agent.
- Monoclonal antibody: At least 21 days must have elapsed after the last dose of antibody.
- Myeloid and platelet growth factors: At least 14 days following the last dose of long-acting myeloid growth factor (e.g. Neulasta) or 7 days following short-acting myeloid or platelet growth factor.
- Autologous hematopoietic stem cell transplant and stem cell boost: Patients must be at least 60 days from day 0 of an autologous stem cell transplant or stem cell boost.
- Cellular Therapies (e.g., CART, NK-cell based therapy): The patient must be and at least 42 days from cellular therapy administration.
- Major Surgery: At least 2 weeks from prior major surgical procedure. Note: Biopsy, CNS shunt placement/revision, and central line placement/removal are not considered major.
- Irinotecan, liposomal irinotecan, and/or temozolomide: Patients may have received prior irinotecan, liposomal irinotecan, and/or temozolomide. NOTE: Patients who have had progressive disease while receiving irinotecan...
- Patients with CNS metastatic disease will not be eligible for the phase 2 EWS and DSRCT cohorts.
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible...
- The effects of PEEL-224 in combination with temozolomide and vincristine on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception...
- Ability to understand and/or the willingness of the patient (or parent or legally authorized representative, if minor) to provide informed consent, using an institutionally approved informed consent procedure.
- Any participant must obtain prior approval from insurance to reimburse oral temozolomide for the duration of the study or agree to self-pay for oral temozolomide.
What rules you out
- Patients who have received prior treatment with PEEL-224.
- Patients who have had progressive disease while receiving irinotecan and temozolomide in combination will be excluded from the Phase 2 EWS and DSRCT cohorts only.
- Participants who are receiving any other anti-cancer agents for this condition.
- Patients receiving strong P450 CYP1A2 and CYP3A4 inhibitors and/or inducers with 14 days of the first planned dose of PEEL-224. NOTE: levofloxacin is permitted and preferred over ciprofloxacin for patients needing a...
- Patients who have received a solid organ or allogeneic stem cell transplant
- Pregnant participants, given that the effects of PEEL-224 on the developing human fetus are unknown.
- Breastfeeding mothers, because there is an unknown risk for adverse events in nursing infants secondary to treatment of the mother with PEEL-224.
- Patients with a history of allergic reactions attributed to PEGylated drugs, camptothecins, temozolomide or vincristine.
- Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 49 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.