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Alkylating agents

Chemotherapy + Surgery for Pleuropulmonary Blastoma

Q: When is Doxorubicin typically recommended for medical treatment?

<p>Patients suffering from <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/multiple-sclerosis">multiple sclerosis</a> and acute myelocytic <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a> may be able to benefit from doxorubicin.</p>

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

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

0 / 1Eligibility criteria met

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

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT01464606 — N/A

Pleuropulmonary Blastoma Research Study Groups: Type I PPB therapy, Types II and III PPB therapy

Pleuropulmonary Blastoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT01464606 — N/A

Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01464606 — N/A

Frequently Asked Questions

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

Are there any open slots available for participants in this experiment?

"As of this time, applications for the referenced clinical trial are not being accepted. First posted in December 2009 and most recently edited on May 2021, it does not appear to be currently recruiting patients. However, there exist one study which is accepting pleuropulmonary blastoma applicants as well as 1004 trials that require Doxorubicin participants."

Answered by AI

Are there any occupancy limits for this experiment?

"Unfortunately, this clinical trial has concluded their search for participants. This specific study was posted to the site on December 22nd 2009 and received its last update on May 26th 2021. However, individuals looking to participate in medical research may find success with 1 currently available trail regarding pleuropulmonary blastoma or 1004 studies utilizing doxorubicin as an intervention."

Answered by AI

What prior research has been done involving Doxorubicin?

"As of now, 1004 Doxorubicin trials are taking place around the globe with 211 studies in their final leg. Philadelphia is the epicenter for these tests but there are 36443 other locations where clinical research related to this drug is being conducted."

Answered by AI

Does this clinical experiment represent an unprecedented approach to treatment?

"Alfacell's 1997 clinical trial of Doxorubicin, which included 300 participants, kickstarted the drug approval process. Over two decades later, there are 1004 active investigations taking place in 69 countries and 2342 cities worldwide."

Answered by AI