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New treatment option for Wilms Tumor
Official title A Study of Selinexor in People With Wilms Tumors and Other Solid Tumors
ClinicalTrials.gov ID: NCT05985161
What this study is testing
What is Selinexor?
Selinexor is an investigational medicine, given as an once-weekly, being studied as a potential treatment for wilms tumor.
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 find out whether selinexor is an effective treatment for people who have a relapsed/refractory Wilms tumor, rhabdoid tumor, MPNST, BCOR-driven sarcoma, or another solid tumor that makes a higher than normal amount of XPO1 or has genetic changes that increase the activity of XP01.
- 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 12 and older
You may be able to join if
- Age:
- Age ≥ 6 at the time of informed consent
- Age ≥ 2 years to \< 6 years at time of informed consent (Refer to Section 4.3): If PK cohort 1 is open, patients in this age range may enroll onto...
- Age ≥ 12 months to \< 2 years at time of informed consent (Refer to Section 4.3): If PK cohort 2 is open, patients in this age range may enroll onto...
- Consent: All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will...
You likely can't join if
- Prior Therapy: Has received selinexor or another XPO1 inhibitor previously.
- Infection: Patients who have an uncontrolled infection are not eligible. Patients on prophylactic antibiotics or with a controlled infection within 1...
- Transplants: Patients who have received allogeneic bone marrow transplant are potentially eligible unless they are being actively treated for GvHD...
- Compliance: Patients who as a result of serious medical, psychiatric, and/or social situation(s), in the opinion of the investigator, may not be able...
- Pregnancy and Breast-feeding: Pregnant or breast-feeding women will not be entered on this study because there is yet no available information...
- Contraception: Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control...
See the full eligibility criteria
Who can join
- Age:
- Age ≥ 6 at the time of informed consent
- Age ≥ 2 years to \< 6 years at time of informed consent (Refer to Section 4.3): If PK cohort 1 is open, patients in this age range may enroll onto this cohort. If PK cohort 1 has been completed and deemed sufficient to...
- Age ≥ 12 months to \< 2 years at time of informed consent (Refer to Section 4.3): If PK cohort 2 is open, patients in this age range may enroll onto this cohort. If PK cohort 2 has been completed and deemed sufficient...
- Consent: All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
- Performance: Karnofsky ≥ 60% for patients \> 16 years of age and Lansky ≥ 60 for patients ≤ 16 years of age.
- Diagnosis: Patients must enroll into one of the following cohorts:
- Cohort A: Any type of Wilms tumor or nephroblastoma is eligible for this study provided they meet at least one of these criteria: (1) in their second or greater relapse, (2) refractory or in their first relapse with...
- Cohort B: Any Rhabdoid tumor is eligible for this cohort. This includes, but is not limited to, related subtypes of rhabdoid tumors such as atypical teratoid rhabdoid tumors (ATRT), malignant rhabdoid tumors of the...
- Cohort C: Patients with progressive, relapsed, unresectable or metastatic MPNST, are eligible for this cohort. Patients must have failed to respond to at least 1 line of systemic therapy prior to enrollment.
- Cohort D: Patients must not qualify for Cohorts A, B, or C but have a solid tumor (no hematologic malignancies including lymphoma) for which there is specific evidence that this particular patient's tumor may benefit...
- Cohort E: Patients must have a solid tumor with an activating genomic alteration (e.g. fusion or internal tandem duplication) involving BCOR. Specific examples of qualifying alterations including BCOR-ITD, BCOR-CCNB3...
- Disease Status: Patients on the phase II portion of the study must have measurable disease whereas patients on the PK cohorts can have either evaluable or measurable disease as measured by the revised Response...
- Prior Therapy: Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and meet minimum washout durations (shown below) from prior therapy.
- Anti-cancer agents not known to be myelosuppressive: ≥ 7 days
- Anti-cancer and cytotoxic agents known to be myelosuppressive: ≥ 21 days
- Immunotherapies (including antibodies, interleukins, interferons, etc.): ≥ 21 days
- Adoptive cellular therapies (including modified T cells, vaccines, etc.): ≥ 42 days
- Autologous stem cell infusion (boost, no conditioning): ≥ 21 days
- Autologous stem cell transplantation (with conditioning): ≥ 42 days
- Allogeneic bone marrow transplantation: ≥ 84 days
- Focal external beam radiation (e.g., limited sites of disease): ≥ 14 days
- Substantial external beam radiation (e.g. whole lung or abdomen): ≥ 42 days
- Radiopharmaceutical therapy (e.g., radiolabeled antibody or MIBG): ≥ 42 days
- Hepatic Function: Adequate function (within 14 days prior to C1D1), defined as:
- Total bilirubin \< 1.5 × upper limit of normal (ULN) (except patients with Gilbert's syndrome, who must have a total bilirubin of \<3 × ULN)
- Alanine aminotransferase (ALT) \< 3 × ULN
- Serum albumin ≥ 2 g/dL
- Renal Function: Adequate function (within 14 days prior to C1D1) defined as a GFR ≥ 50 ml/min/1.73 m2 determined via any of these methods:
- Nuclear radioisotope
- 24 hr urine creatinine clearance
- Serum cystatin c
- Serum creatinine using the Schwartz formula for estimating creatinine clearance (Schwartz et al. J Peds, 106:522, 1985)
- Hematologic Function: Adequate function (within 14 days prior to C1D1), defined as:
- Absolute neutrophil count (ANC) ≥ 1000/mm3
- Platelet count ≥ 100,000/mm3
- Note: patients may not receive platelet transfusions nor hematopoietic growth factor support, including granulocyte-colony stimulating factor (e.g. filgrastim) and platelet stimulators (e.g. romiplostim) for at least 7...
What rules you out
- Prior Therapy: Has received selinexor or another XPO1 inhibitor previously.
- Infection: Patients who have an uncontrolled infection are not eligible. Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable
- Transplants: Patients who have received allogeneic bone marrow transplant are potentially eligible unless they are being actively treated for GvHD. Patients who have had a prior solid organ transplantation are not...
- Compliance: Patients who as a result of serious medical, psychiatric, and/or social situation(s), in the opinion of the investigator, may not be able to comply with supportive care, safety monitoring, or any other key...
- Pregnancy and Breast-feeding: Pregnant or breast-feeding women will not be entered on this study because there is yet no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be...
- Contraception: Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Palo Alto, California, United States
- Washington D.C., District of Columbia, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
- Cincinnati, Ohio, United States
- Fort Worth, Texas, United States
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, 12 months and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Palo Alto, California, United States; Washington D.C., District of Columbia, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States and 10 more location(s). 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.