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New treatment option for Pediatric Sarcoma, Refractory
Official title A Multi-Institution Study of TGFβ Imprinted, Ex Vivo Expanded Universal Donor NK Cell Infusions as Adoptive Immunotherapy in Combination With Gemcitabine and Docetaxel in Patients With Relapsed or Refractory Pediatric Bone and Soft Tissue
ClinicalTrials.gov ID: NCT05634369
What this study is testing
What is GEM/DOX + TGFBi expanded NK cells?
GEM/DOX + TGFBi expanded NK cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pediatric sarcoma, refractory.
Also referred to as Docetaxel, Dexamethasone.
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
- The purpose of this study is to determine if the addition of infusions of a type of immune cell called a "natural killer", or NK cell to the sarcoma chemotherapy regimen GEM/DOX (gemcitabine and docetaxel) can improve outcomes in people with childhood sarcomas that have relapsed or not responded to prior therapies. The goals of this study are: To determine the safety and efficacy of the addition of adoptive transfer of universal donor, TGFβ imprinted (TGFβi), expanded NK cells to the pediatric sarcoma salvage chemotherapeutic regimen gemcitabine/docetaxel (GEM/DOX) for treatment of relapsed and refractory pediatric sarcomas To determine the 6-month progression free survival achieved with this treatment in patients within cohorts of relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 40
You may be able to join if
- Patients must be between the ages ≥ 2 years and ≤ 40 years of age and have had a relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma...
- Patients must have measurable disease using RECIST 1.1 criteria
- Patients must have had at least one and no more than four total lines of cytotoxic systemic treatment for relapse sarcoma. Local control with...
- Prior Therapy: Therapy may not have been received more recently than the timeframes defined below:
- Myelosuppressive chemotherapy: Patients must not have received myelosuppressive therapy within 14 days of protocol therapy
You likely can't join if
- Patients who are receiving any other investigational agents.
- Patients must not be receiving any additional medicines being given for the specific purpose of treating cancer
- Patients with a history of allergic reactions attributed to docetaxel, gemcitabine, or peg-filgrastim or biosimilar
- Patients who have received any prior cellular therapies, such as CAR-T cells or other expanded or manufactured cellular products.
- Patients with bone marrow only disease are not eligible for this study.
- Patients with any of the following "Intermediate" (rarely metastasizing) or "malignant" Grade 2 or Grade 3 tumors of any size, as defined in the WHO...
See the full eligibility criteria
Who can join
- Patients must be between the ages ≥ 2 years and ≤ 40 years of age and have had a relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma.
- Patients must have measurable disease using RECIST 1.1 criteria
- Patients must have had at least one and no more than four total lines of cytotoxic systemic treatment for relapse sarcoma. Local control with surgical resection or radiation therapy of the primary tumor and any...
- Prior Therapy: Therapy may not have been received more recently than the timeframes defined below:
- Myelosuppressive chemotherapy: Patients must not have received myelosuppressive therapy within 14 days of protocol therapy
- Radiation: At least 2 weeks must have elapsed from the start of protocol therapy since local palliative XRT (small port); 4 weeks must have elapsed for all other radiation therapy
- Hematopoietic Cell Transplant (HCT): Patients must have at least 6 weeks elapsed after autologous and allogeneic hematopoietic cell transplant
- Biologic (anti-neoplastic agent): At least 7 days or 5 half-lives of the drug, whichever is longer, must have elapsed from the start of protocol therapy since the completion of therapy with a biologic agent.
- Monoclonal antibodies: At least 3 weeks must have elapsed from the start of protocol therapy since prior therapy that included a monoclonal antibody.
- Prior use of Gemcitabine and/or Docetaxel: Patients who have received these agents for prior treatment may be included if previous treatments were given ≥ 6 months prior to enrollment on this study, and there were no...
- Absolute Neutrophil Count ≥1000/mcL
- Platelet count ≥100,000/mcL transfusion independent defined as no platelet transfusions within the last 72 hours
- Total bilirubin \< 1.5x upper limit of normal for age
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x institutional upper limit of normal
- Serum creatinine \< 1.5 x upper limit of normal based on age/gender (Table 3) OR creatinine clearance ≥70 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Shortening fraction ≥ 27% by ECHO OR ejection fraction of ≥ 50% by ECHO or gated radionuclide study
- Echocardiogram done within 12 months of study entry will be acceptable. If patient has required anthracycline chemotherapy since last ECHO and enrollment on this study, echocardiogram should be repeated.
- No evidence for dyspnea at rest, no chronic oxygen requirement, and room air pulse oximetry \>94% if there is a clinical indication for pulse oximetry 6) Neuropathy: Patients must have ≤ Grade 2 neuropathy at enrollment...
What rules you out
- Patients who are receiving any other investigational agents.
- Patients must not be receiving any additional medicines being given for the specific purpose of treating cancer
- Patients with a history of allergic reactions attributed to docetaxel, gemcitabine, or peg-filgrastim or biosimilar
- Patients who have received any prior cellular therapies, such as CAR-T cells or other expanded or manufactured cellular products.
- Patients with bone marrow only disease are not eligible for this study.
- Patients with any of the following "Intermediate" (rarely metastasizing) or "malignant" Grade 2 or Grade 3 tumors of any size, as defined in the WHO Classification of Soft Tissue Tumors are not eligible for this study:
- So-called fibrohistiocytic tumors - plexiform fibrohistiocytic tumor, giant cell tumor of soft tissues
- Fibroblastic/myofibroblastic tumors - solitary fibrous tumor, malignant solitary fibrous tumor, inflammatory myofibroblastic tumor, low grade myofibroblastic sarcoma, myxoinflammatory fibroblastic sarcoma, atypical...
- Tumors of uncertain differentiation - epithelioid sarcoma, alveolar soft part sarcoma, clear cell sarcoma of soft tissue, angiomatoid fibrous histiocytoma, ossifying fibromyxoid tumour, myoepithelioma, myoepithelial...
- Chondro-osseous tumors - extraskeletal osteosarcoma
- Pericytic (perivascular) tumors - malignant glomus tumor
- Nerve sheath tumors - malignant peripheral nerve sheath tumor, malignant granular cell tumor, epithelioid malignant peripheral nerve sheath tumor, malignant Triton tumor
- Undifferentiated sarcomas (with a specific pathologic category in the WHO classification) - undifferentiated round cell sarcoma, undifferentiated epithelioid sarcoma, undifferentiated spindle cell sarcoma
- Patients who, in the judgment of the treating physician, has tumors near critical structures for which transient swelling would cause substantial symptoms, such as tumor within the bowel mucosa
- Patients with CNS metastatic disease will not be eligible for this study.
- Concomitant Medications:
- Due to their effect on NK cell function, systemic corticosteroids outside of the supportive dexamethasone given from day 7 through 9 should be used ONLY for life-threatening conditions (i.e., life-threatening allergic...
- The following are also prohibited while on study treatment
- Strong CYP3A4 inducers. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list such as http://medicine.iupui.edu/clinpharm/ddis/; medical reference...
- Diazepam
- Chemotherapeutic agents other than the study drugs
- Uncontrolled intercurrent illness including, but not limited to:
- ongoing or active infection
- psychiatric illness/social situations that would limit compliance with study requirements
- Pregnancy or Breast-Feeding: Pregnant or breast-feeding woman will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies with Gemcitabine and Docetaxel
- HIV Infection: HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with the study medications. In addition, these patients are at...
- Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.
The study team makes the final eligibility decision.
Where it's taking place
- South Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- St. Petersburg, Florida, United States
- St Louis, Missouri, United States
- Buffalo, New York, United States
- The Bronx, New York, United States
- Chapel Hill, North Carolina, United States
- Charlotte, North Carolina, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include South Birmingham, Alabama, United States; Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Los Angeles, California, United States; Palo Alto, California, United States; Gainesville, Florida, United States and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.