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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

All patients will have completed front-line therapy

Must not have

Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of study participation

Any primary central nervous system tumor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to five years off therapy

Awards & highlights

All Individual Drugs Already Approved

Approved for 20 Other Conditions

No Placebo-Only Group

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.

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.

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).

Eligibility Criteria

Inclusion Criteria

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

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My cancer is one of the following: rhabdomyosarcoma, osteosarcoma, Ewing sarcoma, or another soft tissue sarcoma.

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I have finished my initial cancer treatment.

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My primary cancer is currently in remission.

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I am between 1 and 30 years old.

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I can do most activities but may need help.

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My kidney function is normal, based on my creatinine levels.

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My heart is strong, with a good pumping efficiency.

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My white blood cell count is sufficient.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am using effective birth control during the study.

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I have a brain tumor.

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My cancer has returned or stopped responding to treatment, or I have had another type of cancer.

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My cancer is not in remission.

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I am currently pregnant.

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I am a woman able to have children and have a negative pregnancy test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to five years off therapy

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

5 year Event Free Survival

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Secondary study objectives

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

vitreous syneresis

posterior capsule opacification

cranial nerve VI palsy

pneumonia

pyelonephritis

colon cancer

bradycardia

100%

80%

60%

40%

20%

Study treatment Arm

Bevacizumab

Ozurdex

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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). 1. Bevacizumab: IV, 10 mg/kg, Days 1, 8 2. Cyclophosphamide: PO, 25 mg/m2 Days 1-14 (max dose = 50mg/dose) 3. Valproic Acid: PO, 5 mg/kg, three times per day (TID), Days 22-35 4. Temsirolimus: IV, 25 mg/m2, Days 22, 29

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

FDA approved

Valproic acid

FDA approved

Bevacizumab

FDA approved

Temsirolimus

FDA approved