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Anti-Angiogenic Therapy Post Transplant for Pediatric Cancer (ASCR Trial)
Phase 1
Waitlist Available
Led By Andrew Cluster, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within the first year of transplant
Awards & highlights
ASCR Trial Summary
This trial is testing whether two drugs that stop blood vessel growth can prevent cancer from returning or growing after stem cell transplant.
Who is the study for?
This trial is for children and young adults up to 21 years old with certain solid tumors who've had a stem cell transplant. They should have stable health, no severe organ dysfunction, not be on other experimental drugs, and not be pregnant or breastfeeding. Participants need good heart, lung, kidney function and must agree to birth control measures if taking thalidomide.Check my eligibility
What is being tested?
The study tests low-dose Metronomic Cyclophosphamide or Thalidomide's ability to prevent new blood vessel growth post-stem cell transplant in pediatric patients. It aims to see if this can stop tumor growth by cutting off their blood supply.See study design
What are the potential side effects?
Possible side effects include risks of infection due to immune system suppression, bleeding issues from reduced platelets, potential harm to unborn babies (thalidomide), nerve damage causing pain or numbness (thalidomide), and increased risk of blood clots.
ASCR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 1 year post-transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 1 year post-transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of major transplant related toxicities (Grades IV and IV)
Safety as measured by absence of grade 4 or 5 non-hematological or grade 5 hematological toxicity
Secondary outcome measures
Best overall response
ASCR Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: ThalidomideExperimental Treatment1 Intervention
Thalidomide will be initiated at 3mg/kg PO daily beginning Day + 30 (30 days post transplant) and continue until Day +86
Group II: Metronomic CyclophosphamideExperimental Treatment1 Intervention
Cyclophosphamide will be given PO once daily at 2.5 mg/kg/day for children < 40kg or 100 mg daily for children > 40kg beginning Day + 30 (30 days post transplant) and continue until at least Day +86
Group III: ControlActive Control1 Intervention
No intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metronomic Cyclophosphamide
2012
Completed Phase 1
~20
Thalidomide
2001
Completed Phase 4
~3050
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,859 Total Patients Enrolled
2 Trials studying Wilms Tumor
3,400 Patients Enrolled for Wilms Tumor
Andrew Cluster, M.D.Principal InvestigatorWashington University School of Medicine
2 Previous Clinical Trials
22 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your liver function tests must be within a certain range: total bilirubin levels must be below a certain limit, and SGOT or SGPT levels must also be within specific limits.You have had radiation therapy or chemotherapy before, and that's okay.You have received certain kinds of treatment for blood vessel growth before, and that's okay.Your kidneys must be working well, with a creatinine level below 1.5 mg/dl and a GFR of at least 70 mL/min.You have not had a blood clot in your veins or lungs within the last 3 weeks before joining the study.Patients with brain stem gliomas do not need to have a biopsy if their tumor has grown after radiation therapy.You have been diagnosed with specific types of brain tumors, kidney tumors, muscle tumors, or eye tumors, and have had a biopsy to confirm the diagnosis. This study does not include blood-related cancers like lymphomas.You must be between 6 months and 21 years old to take part in the study.Before joining the study, you need to have a certain amount of stem cells collected and stored from your blood or bone marrow. If you don't have enough stem cells from your blood, you can have them collected from your bone marrow instead.You need to have enough red blood cells and white blood cells in your body.You need to have good lung function, meaning your oxygen levels are above 94% without extra oxygen, and you don't have trouble breathing when you're resting.You must be able to perform daily activities with a certain level of independence, even if you use a wheelchair.Your heart must be working well, as shown by recent tests like echocardiogram or radionuclide angiogram.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Metronomic Cyclophosphamide
- Group 3: Thalidomide
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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