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Anti-tumor antibiotic

Chemotherapy + Radiation for Hodgkin's Lymphoma

Q: Has the FDA cleared radiation therapy for use?

Given that this is a Phase 2 trial, meaning that while there is some data supporting safety, none yet supports efficacy, our team has given Radiation Therapy a score of 2.

Q: How many different hospitals are conducting this research?

There are six principle hospitals conducting this research, for example Children's Hospital of <a href="https://www.withpower.com/clinical-trials/illinois">Illinois</a> at OSF St. Francis Medical Center in Peoria, Rady Children's Hospital- San Diego in San Diego, and Packard Children's Hospital, Stanford University in Palo Alto. In addition to those locations, there are also 6 other sites.

Q: Are participants still being recruited for this research?

This clinical trial is not actively recruiting patients. The last update on the website was on August 9th, 2022. There are 1770 other studies that are active right now.

Phase 2

Waitlist Available

Led By Jamie Flerlage, MD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stage must be classified as Ann Arbor stage IA or IIA with: Non-bulky mediastinal disease (< 33% mediastinal to thoracic ratio on CXR), < 3 nodal regions involved on the same side of the diaphragm, No 'E' lesion

Histologically confirmed, previously untreated Hodgkin lymphoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up median 2 year post therapy

Awards & highlights

Study Summary

This trial is studying a combination of chemotherapy drugs with or without radiation therapy to see how well it treats young patients with a low-risk form of Hodgkin lymphoma.

Who is the study for?

This trial is for young patients, 21 years or younger, with a type of cancer called favorable-risk Hodgkin lymphoma. They should not have been treated before and must have specific early stages of the disease without extensive spread. Girls after puberty need a negative pregnancy test and all participants able to have children must use birth control.Check my eligibility

What is being tested?

The study is testing how well a mix of chemotherapy drugs works compared to the same chemo plus radiation therapy in these young patients. The goal is to see if adding radiation helps more when some cancer remains after chemo, while trying to preserve healthy body parts.See study design

What are the potential side effects?

Chemotherapy can cause side effects like nausea, hair loss, fatigue, increased risk of infections due to low blood cell counts, and potential damage to organs such as the heart or lungs. Radiation may lead to skin irritation at the treatment site and possible long-term risks like secondary cancers.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is early stage with limited spread and no extranodal involvement.

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My Hodgkin lymphoma diagnosis is confirmed and I haven't received any treatment yet.

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I am 21 years old or younger.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ median 2 year post therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~median 2 year post therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and median 2 year post 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

Complete Response Rate Estimate

Secondary outcome measures

Acute Hematologic Toxicities

Acute Infectious Toxicities

Comparison of Event-free Survival Distributions Between Patients That Will Not be Prescribed Radiotherapy After 8 Weeks Stanford V and Those Patients on HOD99 That Received VAMP Without Radiotherapy

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment2 Interventions

Participants receive Stanford V Chemotherapy with or without radiation therapy. Patients receive doxorubicin hydrochloride IV and vinblastine IV on day 1 of weeks 1, 3, 5, and 7; mechlorethamine hydrochloride IV on day 1 of weeks 1 and 5; vincristine sulfate IV and bleomycin IV on day 1 of weeks 2, 4, 6, and 8; etoposide IV on day 1 of weeks 3 and 7; and prednisone orally (PO) three times daily every other day of weeks 1-8. Beginning 2-3 weeks after completion of chemotherapy, patients not achieving complete response undergo radiation therapy to individual nodal sites (tailored fields)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor

429 Previous Clinical Trials

5,306,670 Total Patients Enrolled

Jamie Flerlage, MDPrincipal InvestigatorSt. Jude Children's Research Hospital

4 Previous Clinical Trials

481 Total Patients Enrolled

Monika Metzger, MDPrincipal InvestigatorSt. Jude Children's Research Hospital

3 Previous Clinical Trials

414 Total Patients Enrolled

Media Library

Bleomycin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT00846742 — Phase 2

Hodgkin's Lymphoma Research Study Groups: Treatment

Hodgkin's Lymphoma Clinical Trial 2023: Bleomycin Highlights & Side Effects. Trial Name: NCT00846742 — Phase 2

Bleomycin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00846742 — Phase 2

Frequently Asked Questions

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

Has the FDA cleared radiation therapy for use?

"Given that this is a Phase 2 trial, meaning that while there is some data supporting safety, none yet supports efficacy, our team has given Radiation Therapy a score of 2."

Answered by AI

How many different hospitals are conducting this research?

"There are six principle hospitals conducting this research, for example Children's Hospital of Illinois at OSF St. Francis Medical Center in Peoria, Rady Children's Hospital- San Diego in San Diego, and Packard Children's Hospital, Stanford University in Palo Alto. In addition to those locations, there are also 6 other sites."

Answered by AI

Are participants still being recruited for this research?

"This clinical trial is not actively recruiting patients. The last update on the website was on August 9th, 2022. There are 1770 other studies that are active right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Favorable-Risk Hodgkin Lymphoma

2009. "Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Favorable-Risk Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00846742.

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