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Alkylating Agent

Prexasertib + Chemotherapy for Brain Cancer

Q: What results are researchers hoping to realize from this research venture?

The primary outcome of this medical trial, taking place over a month long period, is to observe the safety and tolerance of prexasertib combined with cyclophosphamide or gemcitabine. Secondary objectives include quantifying systemic clearance (CL) for Gemcitabine through course 1 day 1 samples, estimating progression-free survival for patients treated with these drugs by employing Kaplan Meier approach and calculating area under concentration-time curve (AUC0-24h) for 4-hydroxycyclophosphamide from course 1 days 1 &#x26; 2 PK samples.

Q: Can I join this clinical trial?

This medical study is looking for 21 participants aged between 1 year and 24 years with a diagnosis of cns neoplasm. In addition to this, these patients must have recurrent, refractory or progressive <a href="https://www.withpower.com/clinical-trials/medulloblastoma">medulloblastoma</a>; be capable of understanding and signing the informed consent document as per institution rules; and fulfill <a href="https://www.withpower.com/clinical-trials/all">all</a> other criteria during the screening phase.

Q: Are there any antecedent investigations involving Cyclophosphamide?

Currently, there are 1340 active research studies concerning Cyclophosphamide with 306 in the third phase of their trials. The majority of these can be found in Philadelphia but overall 54122 sites across the globe have conducted experiments involving this medication.

Q: What potential risks does Cyclophosphamide pose to individuals?

Cyclophosphamide's safety is still relatively untested and therefore our team at Power arrived at a score of 1. This is due to it being categorized as a Phase 1 trial, meaning there only exists preliminary data on its efficacy and security.

Q: What is the enrollment capacity for this clinical trial?

At present, this investigation is not recruiting. The trial was initially published on August 8th 2019 and its details were last altered on October 20th 2022. If you are looking for other research opportunities, there are 3692 investigations seeking participants with cns neoplasms and 1340 studies involving Cyclophosphamide actively enrolling patients.

Q: What diseases are typically treated with Cyclophosphamide?

Cyclophosphamide is a viable treatment for lung malignancies, including <a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a> (<a href="https://www.withpower.com/clinical-trials/sclc">SCLC</a>). Additionally, it has been used to treat <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a> and acute myelocytic <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>.

Q: Are more participants being sought for this experiment?

As indicated on clinicaltrials.gov, this particular medical trial is not currently accepting patients. This study was first posted on August 8th 2019 with the last update being October 20th 2022. Although this specific trial is inactive at present, there are 5032 other studies that require participants right away.

Q: Is this research project seeking participants aged 45 or older?

The protocol for this medical study necessitates that its participants be between one year and 24 years old. There are 857 trials in progress for those under 18, while 4442 are geared towards individuals above the age of 65.

Phase 1

Waitlist Available

Led By Giles W. Robinson, MD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must be ≥1 year and <25 years of age at time of screening

Participant must have received their last dose of myelosuppressive anticancer chemotherapy at least 3 weeks prior to study enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years from diagnosis

Awards & highlights

Study Summary

This trial is a phase 1 trial that will study the combination of prexasertib with two established DNA-damaging agents, cyclophosphamide and gemcitabine, to treat patients with recurrent or refractory medulloblastoma. The goal is to evaluate the safety and tolerability of this combination therapy and to determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D). Additionally, a small expansion cohort will be treated at the MTD/RP2D to assess preliminary efficacy.

Who is the study for?

This trial is for children and adolescents aged 1 to less than 25 with recurrent or stubborn Group 3/Group 4 or SHH medulloblastoma brain tumors. They should have measurable disease, be at least three weeks out from chemotherapy, four weeks from radiation, and not on increasing steroids. Participants need a certain level of physical ability and life expectancy, as well as proper organ function. Pregnant women can't join; those who can have kids must use birth control.Check my eligibility

What is being tested?

The SJELIOT phase 1 trial tests prexasertib combined with cyclophosphamide (Stratum A) or gemcitabine (Stratum B) in young patients with tough-to-treat brain tumors. It aims to find the safest dose that works and understand how the body processes these drugs while looking for early signs of effectiveness.See study design

What are the potential side effects?

Possible side effects include reactions related to bone marrow suppression like anemia and increased risk of infection due to low white blood cell counts, nausea, vomiting, hair loss from cyclophosphamide; plus fatigue and liver issues could occur with both drug combinations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 1 and 24 years old.

Select...

I received my last chemotherapy dose more than 3 weeks ago.

Select...

I am between 1 and 24 years old.

Select...

My medulloblastoma has come back or is not responding to treatment.

Select...

My medulloblastoma has come back or is not responding to treatment.

Select...

I am of childbearing age and have a negative pregnancy test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years from diagnosis

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years from diagnosis

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years from diagnosis for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Estimate the Maximum tolerated dose (MTD)/Recommended Phase 2 Dose (RP2D) of each doublet by stratum

To characterize the area under the concentration-time curve (AUC0-∞) of prexasertib in combination with cyclophosphamide or gemcitabine.

To characterize the systemic clearance (CL) of prexasertib in combination with cyclophosphamide or gemcitabine.

+1 more

Secondary outcome measures

Duration of objective response by stratum

Progression-free survival for patients treated with prexasertib and cyclophosphamide or gemcitabine

Rate of objective response (complete or partial response) by stratum

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: B: prexasertib + gemcitabineExperimental Treatment4 Interventions

Stratum B: Participants receive combination treatment with gemcitabine given intravenously (IV) on days 1 and 15 and prexasertib given intravenously (IV) on days 2 and 16. Cycles repeat every 28 days for up to 24 months (26 cycles) in the absence of disease progression or unacceptable toxicity. They may also receive growth therapy support with filgrastim or peg-filgrastim. Note: Only if absolutely necessary, gemcitabine may be given on day 16 and prexasertib may be given on day 17.

Group II: A: prexasertib + cyclophosphamideExperimental Treatment4 Interventions

Stratum A: Participants receive combination treatment with cyclophosphamide given intravenously (IV) on days 1 and 15 and prexasertib given intravenously (IV) on days 2 and 16. Cycles repeat every 28 days for up to 24 months (26 cycles) in the absence of disease progression or unacceptable toxicity. They may also receive growth therapy support with filgrastim or peg-filgrastim. Note: Only if absolutely necessary, cyclophosphamide may be given on day 16 and prexasertib may be given on day 17.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

Prexasertib

2017

Completed Phase 2

~810

Gemcitabine

2017

Completed Phase 3

~2070

filgrastim

1997

Completed Phase 3

~7260

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor

428 Previous Clinical Trials

5,306,592 Total Patients Enrolled

13 Trials studying Medulloblastoma

2,875 Patients Enrolled for Medulloblastoma

Eli Lilly and CompanyIndustry Sponsor

2,618 Previous Clinical Trials

3,201,496 Total Patients Enrolled

2 Trials studying Medulloblastoma

72 Patients Enrolled for Medulloblastoma

Giles W. Robinson, MDPrincipal InvestigatorSt. Jude Children's Research Hospital

3 Previous Clinical Trials

320 Total Patients Enrolled

2 Trials studying Medulloblastoma

188 Patients Enrolled for Medulloblastoma

Media Library

Cyclophosphamide (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04023669 — Phase 1

Medulloblastoma Research Study Groups: A: prexasertib + cyclophosphamide, B: prexasertib + gemcitabine

Medulloblastoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT04023669 — Phase 1

Cyclophosphamide (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04023669 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What results are researchers hoping to realize from this research venture?

"The primary outcome of this medical trial, taking place over a month long period, is to observe the safety and tolerance of prexasertib combined with cyclophosphamide or gemcitabine. Secondary objectives include quantifying systemic clearance (CL) for Gemcitabine through course 1 day 1 samples, estimating progression-free survival for patients treated with these drugs by employing Kaplan Meier approach and calculating area under concentration-time curve (AUC0-24h) for 4-hydroxycyclophosphamide from course 1 days 1 & 2 PK samples."

Answered by AI

Can I join this clinical trial?

"This medical study is looking for 21 participants aged between 1 year and 24 years with a diagnosis of cns neoplasm. In addition to this, these patients must have recurrent, refractory or progressive medulloblastoma; be capable of understanding and signing the informed consent document as per institution rules; and fulfill all other criteria during the screening phase."

Answered by AI

Are there any antecedent investigations involving Cyclophosphamide?

"Currently, there are 1340 active research studies concerning Cyclophosphamide with 306 in the third phase of their trials. The majority of these can be found in Philadelphia but overall 54122 sites across the globe have conducted experiments involving this medication."

Answered by AI

What potential risks does Cyclophosphamide pose to individuals?

"Cyclophosphamide's safety is still relatively untested and therefore our team at Power arrived at a score of 1. This is due to it being categorized as a Phase 1 trial, meaning there only exists preliminary data on its efficacy and security."

Answered by AI

What is the enrollment capacity for this clinical trial?

"At present, this investigation is not recruiting. The trial was initially published on August 8th 2019 and its details were last altered on October 20th 2022. If you are looking for other research opportunities, there are 3692 investigations seeking participants with cns neoplasms and 1340 studies involving Cyclophosphamide actively enrolling patients."

Answered by AI

What diseases are typically treated with Cyclophosphamide?

"Cyclophosphamide is a viable treatment for lung malignancies, including small cell lung cancer (SCLC). Additionally, it has been used to treat multiple sclerosis and acute myelocytic leukemia."

Answered by AI

Are more participants being sought for this experiment?

"As indicated on clinicaltrials.gov, this particular medical trial is not currently accepting patients. This study was first posted on August 8th 2019 with the last update being October 20th 2022. Although this specific trial is inactive at present, there are 5032 other studies that require participants right away."

Answered by AI

Is this research project seeking participants aged 45 or older?

"The protocol for this medical study necessitates that its participants be between one year and 24 years old. There are 857 trials in progress for those under 18, while 4442 are geared towards individuals above the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of LY2606368 Therapy in Combination With Cyclophosphamide or Gemcitabine for Children and Adolescents With Refractory or Recurrent Group 3/Group 4 or SHH Medulloblastoma Brain Tumors

2019. "Evaluation of LY2606368 Therapy in Combination With Cyclophosphamide or Gemcitabine for Children and Adolescents With Refractory or Recurrent Group 3/Group 4 or SHH Medulloblastoma Brain Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04023669.

All > Brain Cancer > Medulloblastoma