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Alkylating agents
Chemotherapy + Surgery for Pleuropulmonary Blastoma
N/A
Waitlist Available
Led By Kris Ann P Schultz, MD
Research Sponsored by Children's Hospitals and Clinics of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
DICER1-related condition and DICER1 gene mutation: all patients are eligible and will be followed in the study
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is studying a combination of two drugs, vincristine and cisplatin, given together with surgery in patients with pleuropulmonary blastoma.
Who is the study for?
This trial is for children and young adults up to 21 years old with a rare lung tumor called Pleuropulmonary Blastoma (PPB). It includes those newly diagnosed, or with prior PPB, confirmed by central pathology review. Patients must be able to give consent through a guardian and may have had previous corticosteroid therapy.Check my eligibility
What is being tested?
The trial tests a treatment program using drugs like Doxorubicin, Vincristine, Dactinomycin, Cyclophosphamide, and Ifosfamide on many patients to determine the effectiveness against PPB since there's no standard treatment due to its rarity.See study design
What are the potential side effects?
Possible side effects of the drugs include hair loss, nausea and vomiting, mouth sores, increased risk of infections due to low blood cell counts, bleeding or bruising from low platelets, and potential damage to heart or kidneys.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a DICER1-related condition and a DICER1 gene mutation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event-free survival
Secondary outcome measures
Overall response to chemotherapy, and survival
Trial Design
2Treatment groups
Experimental Treatment
Group I: Types II and III PPB therapyExperimental Treatment5 Interventions
Combination chemotherapy with Ifosfamide, Vincristine, Dactinomycin and Doxorubicin ("IVADo"). Second look and possible 3rd look surgery may be required. Radiation therapy is recommended only for residual disease after maximum surgery.
Group II: Type I PPB therapyExperimental Treatment3 Interventions
PPB Type I therapy: All patients will be treated with surgery. Chemotherapy after surgery is per the treating physician(s) discretion. If chemotherapy is used the Registry will suggest that it be combination chemotherapy with Vincristine, Dactinomycin, Cyclophosphamide (VAC).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ifosfamide
FDA approved
Doxorubicin
FDA approved
Vincristine
FDA approved
Dactinomycin
FDA approved
Cyclophosphamide
FDA approved
Find a Location
Who is running the clinical trial?
Children's Hospitals and Clinics of MinnesotaLead Sponsor
65 Previous Clinical Trials
5,022,083 Total Patients Enrolled
1 Trials studying Pleuropulmonary Blastoma
3,400 Patients Enrolled for Pleuropulmonary Blastoma
Kris Ann P Schultz, MDPrincipal InvestigatorChildren's Hospitals and Clinics of Minnesota
2 Previous Clinical Trials
3,700 Total Patients Enrolled
1 Trials studying Pleuropulmonary Blastoma
3,400 Patients Enrolled for Pleuropulmonary Blastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you have PPB Type I, you can participate in the study.I have a DICER1-related condition and a DICER1 gene mutation.I have previously been treated with corticosteroids.My PPB has progressed from Type I to Type II or III.I was diagnosed with my condition before turning 21.My age does not limit my participation in the study's Associated Diseases arm.My initial tests hinted at PPB, but it was confirmed later, possibly after treatment.My PPB cancer diagnosis has been confirmed by a pathologist.I am unable to understand or give consent for treatment.You have had central pathology review ruling out a diagnosis of pleuropulmonary blastoma.I have been newly diagnosed with Type II or III PPB.
Research Study Groups:
This trial has the following groups:- Group 1: Type I PPB therapy
- Group 2: Types II and III PPB therapy
Awards:
This trial has 3 awards, including:- 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.
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.
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