← Back to Search

Anti-angiogenic Agent

Metronomic Chemotherapy for Pediatric High-Risk Cancer (Metronomic Trial)

Phase < 1
Recruiting
Led By Ted Zwerdling, MD
Research Sponsored by Miller Children's & Women's Hospital Long Beach
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The following solid tumors will be studied: rhabdomyosarcoma, osteosarcoma, Ewing sarcoma, other soft tissue sarcomas
Other solid tumors fulfilling the remainder of eligibility criteria and available historical data to determine time to tumor progression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to five years off therapy
Awards & highlights

Metronomic Trial Summary

This trial studied the effectiveness of metronomic therapy given in the first-line setting to pediatric patients with high-risk solid tumors.

Who is the study for?
This trial is for pediatric patients aged 12 months to less than 31 years with specific solid tumors like rhabdomyosarcoma and osteosarcoma, who are in remission but at high risk of recurrence. They must have completed initial therapy, be within six weeks post-treatment, not pregnant or breastfeeding, and willing to use contraception if applicable.Check my eligibility
What is being tested?
The study tests metronomic therapy using lower doses of Bevacizumab, Cyclophosphamide, Valproic Acid, and Temsirolimus continuously on children with solid tumors. It aims to see if this approach can prevent cancer from coming back while being less toxic and more cost-effective.See study design
What are the potential side effects?
Possible side effects include blood pressure changes (Bevacizumab), bladder issues and hair loss (Cyclophosphamide), liver damage and drowsiness (Valproic Acid), as well as mouth sores and weakened immune system (Temsirolimus).

Metronomic Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is one of the following: rhabdomyosarcoma, osteosarcoma, Ewing sarcoma, or another soft tissue sarcoma.
Select...
I have a solid tumor with known progression timeline.
Select...
I have finished my initial cancer treatment.
Select...
My primary cancer is currently in remission.
Select...
I will begin low-dose therapy within 6 weeks after my initial treatment.
Select...
My kidney function is normal.
Select...
I have recovered from minor surgery for 7 days or major surgery for 28 days.
Select...
My heart is strong enough, meeting the required health standards.
Select...
My cancer is one of the following: rhabdomyosarcoma, osteosarcoma, Ewing sarcoma, or another soft tissue sarcoma.
Select...
I have finished my initial cancer treatment.
Select...
My primary cancer is currently in remission.
Select...
I am between 1 and 30 years old.
Select...
I can do most activities but may need help.
Select...
My kidney function is normal, based on my creatinine levels.
Select...
My heart is strong, with a good pumping efficiency.
Select...
My white blood cell count is sufficient.
Select...
I am between 1 and 30 years old.
Select...
I can do most activities but may need help.
Select...
My white blood cell count is healthy.

Metronomic Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to five years off therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to five years off therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
5 year Event Free Survival
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Secondary outcome measures
Composite Cost of Treatment
Fatigue scores on the PedsQL Fatigue Scale
Pain scores on the Present Functioning Scale
+2 more

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424
22%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
cranial nerve VI palsy
4%
bradycardia
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex

Metronomic Trial Design

1Treatment groups
Experimental Treatment
Group I: Metronomic TherapyExperimental Treatment4 Interventions
There is only one arm in this study. All subjects receive the same therapy for a period of 420 days (42 day cycles x 10 cycles). Bevacizumab: IV, 10 mg/kg, Days 1, 8 Cyclophosphamide: PO, 25 mg/m2 Days 1-14 (max dose = 50mg/dose) Valproic Acid: PO, 5 mg/kg, three times per day (TID), Days 22-35 Temsirolimus: IV, 25 mg/m2, Days 22, 29
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
Cyclophosphamide
FDA approved
Valproic acid
FDA approved
Temsirolimus
FDA approved

Find a Location

Who is running the clinical trial?

Miller Children's & Women's Hospital Long BeachLead Sponsor
1 Previous Clinical Trials
100 Total Patients Enrolled
Children's Hospital of Orange CountyOTHER
32 Previous Clinical Trials
4,914 Total Patients Enrolled
Ted Zwerdling, MDPrincipal InvestigatorMiller Children's and Women's Hospital Long Beach

Media Library

Bevacizumab (Anti-angiogenic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT02446431 — Phase < 1
Solid Tumors Research Study Groups: Metronomic Therapy
Solid Tumors Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT02446431 — Phase < 1
Bevacizumab (Anti-angiogenic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02446431 — Phase < 1

Frequently Asked Questions

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

Has Bevacizumab been subject to previous research investigations?

"Currently, 1186 trials are running research on Bevacizumab with 246 of them in the third stage. Despite the high concentration of studies located in Philadelphia, Pennsylvania, there is a total number of 43963 locations examining this particular treatment."

Answered by AI

Is it possible for me to participate in this clinical trial?

"In order to be accepted into this study, participants must have a solid tumor and fall in the 12 month - 31 year age range. A total of 20 individuals are being sought out for the experiment."

Answered by AI

How many individuals have chosen to partake in this experiment?

"Affirmative. Clinicaltrials.gov indicates that this trial, which was first uploaded on July 1st 2014, is actively recruiting patients. To participate in the study, 20 individuals need to be recruited between two different sites."

Answered by AI

What medical conditions has Bevacizumab been shown to effectively control?

"Bevacizumab is used to abate advanced forms of ovarian cancer that are resistant to platinum-based treatments. It has also been proven effective at managing malignant neoplasms, multiple sclerosis, and recurrent primary peritoneal cancer sensitive to platinum."

Answered by AI

Are there any opportunities for enrollment in this trial currently?

"Affirmative. The clinicaltrial.gov database suggests that this medical trial is currently recruiting patients, having first been advertised on July 1st 2014 and updated most recently on May 13th 2015. It requires only 20 participants to be recruited across two sites."

Answered by AI

What is the ultimate goal of this research endeavor?

"This long-term trial has the primary goal of determining safety and tolerability, measured by counting adverse events. Secondary objectives involve assessing patients' quality of life with PedsQL Quality of Life Scale, fatigue levels via PedsQL Fatigue Scale and pain experienced through Present Functioning Scale."

Answered by AI

Are individuals aged 45 and above eligible to join this experiment?

"This trial is seeking out participants aged 12 Months to 31, with 517 trials available for those younger than 18 and 2298 for senior citizens."

Answered by AI
~0 spots leftby Jul 2024