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New treatment option for Medulloblastoma
Official title Individualized Treatment Plan in Children and Young Adults With Relapsed Medulloblastoma and Ependymoma
ClinicalTrials.gov ID: NCT05057702
What this study is testing
- What it's testing
- The current study will use a new treatment approach based on the molecular characteristics of each participant's tumor. The study will test the feasibility in the pilot phase of performing real-time drug screening on tissue taken during surgery in patients with relapsed medulloblastoma or ependymoma and of having a specialized tumor board assign a treatment plan based on the results of this screening and genomic sequencing.
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 39
You may be able to join if
- Participants must have recurrent medulloblastoma or recurrent ependymoma previously histologically confirmed. Participants must be experiencing their...
- Participants must have surgically accessible disease.
- Prior Therapy:
- The participant must have received at least one prior therapy at the time of initial diagnosis.
- Relapsed medulloblastoma or relapsed ependymoma are eligible.
You likely can't join if
- Participants who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those...
- Participants who are receiving any other investigational agents.
- Participants must be at least 7 days since the completion of therapy with a biologic or small molecule agent. For any agent with known adverse events...
- Participants who are currently taking any anti-cancer direct therapy. Steroids are not considered anti-cancer therapy.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection.
- Women of childbearing potential must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required prior to start of...
See the full eligibility criteria
Who can join
- Participants must have recurrent medulloblastoma or recurrent ependymoma previously histologically confirmed. Participants must be experiencing their first or second relapse to be eligible.
- Participants must have surgically accessible disease.
- Prior Therapy:
- The participant must have received at least one prior therapy at the time of initial diagnosis.
- Relapsed medulloblastoma or relapsed ependymoma are eligible.
- Participants must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study and would be eligible for surgical resection per institutional...
- Participants must have received last chemotherapy or biologic agent at least 7 days prior to registration.
- Monoclonal antibody treatment: \> 21 days prior to registration.
- Bevacizumab participants must have received last dose \> 21 days prior to study registration
- Participant must be a candidate for surgical resection or biopsy with anticipated ability to obtain the minimum tissue requirements for study.
- Radiation - Participants must have:
- Had their last fraction of local irradiation to primary tumor \>= 12 weeks prior to registration.
- Had their last fraction of craniospinal irradiation or total body irradiation \>= 12 weeks prior to registration
- At least 14 days after local palliative radiation (small-port)
- Age \>=12 months to \<= 39 years of age.
- Karnofsky \>= 50 for participants \> 16 years of age and Lansky \>= 50 for participants \<= 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered...
- Corticosteroids: Participants who are receiving dexamethasone or equivalent must be on a stable or decreasing dose for at least 1 week prior to registration.
- Organ Function Requirements (within 7 days prior to study registration)
- Adequate Bone Marrow Function Defined as:
- Peripheral absolute neutrophil count (ANC) \>= 750/mm\^3
- Platelet count \>= 75,000/mm\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).
- Hemoglobin \>= 8 g/dl.
- Adequate Renal Function Defined as:
- Creatinine clearance or radioisotope GFR \>= 70 milliliter/minute (mL/min) /1.73 m\^2 or
- A serum creatinine based on age/sex as follows: Age / Maximum Serum Creatinine (mg/dL) Male / Maximum Serum Creatinine (mg/dL) Female.
- 1 to \< 2 years / 0.6 / 0.6.
- 2 to \< 6 years / 0.8 / 0.8.
- 6 to \< 10 years / 1 / 1.
- 10 to \< 13 years / 1.2 / 1.2.
- 13 to \< 16 years / 1.5 / 1.4.
- \>= 16 years / 1.7 / 1.4.
- \- The threshold creatinine values in this table were derived from the Schwartz formula for estimating Glomerular filtration rate (GFR) utilizing child length and stature data published by the Center for Disease Control...
- Adequate Liver Function Defined as:
- Total Bilirubin \<= 1.5 x upper limit of normal (ULN) for age; in presence of Gilbert's syndrome, total bilirubin \< 3 x ULN or direct bilirubin \< 1.5 x ULN.
- Alanine aminotransferase (ALT) \<= 3x ULN.
- Aspartate aminotransferase (AST) \<= 3x ULN.
- The effects of the agents used in this study on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of...
- Adequate neurologic function defined as participants with seizure disorder may be enrolled if seizures are well controlled. Participants on non-enzyme inducing anticonvulsants may be excluded pending interaction(s) with...
- Participants must enroll on the Protocol for Children and Young Adults Diagnosed with a Central Nervous System (CNS) Tumor to Assess Cognitive, Quality of Life (QOL), and Comprehensive Effects of Therapies (PNOC COMP)...
- A legal parent/guardian or participant must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate.
What rules you out
- Participants who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered...
- Participants who are receiving any other investigational agents.
- Participants must be at least 7 days since the completion of therapy with a biologic or small molecule agent. For any agent with known adverse events that can occur beyond 7 days after administration, the period prior...
- Participants who are currently taking any anti-cancer direct therapy. Steroids are not considered anti-cancer therapy.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection.
- Women of childbearing potential must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required prior to start of therapy.
- Participants must not receive any tumor-directed therapy after enrollment, except for surgical resection/ biopsy. Important note: The eligibility criteria listed above are interpreted literally and cannot be waived.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Washington D.C., District of Columbia, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, 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 to 39 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Diego, California, United States; San Francisco, California, United States; Washington D.C., District of Columbia, United States; St Louis, Missouri, United States; New York, New York, United States and 1 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.