← Back to Search

Alkylating agents

Surgery, Radiation & Chemotherapy for Early-Stage Hodgkin's Lymphoma

Phase 2

Waitlist Available

Led By Burton Appel, MD

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

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

Must have

No prior radiotherapy

Patients with newly diagnosed, previously untreated, biopsy-proven lymphocyte predominant Hodgkin disease (LPHD) are eligible for this protocol as follows:

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 2 years

Awards & highlights

Study Summary

This trial is studying how well surgery, radiation therapy, and/or combination chemotherapy work in treating young patients with newly diagnosed stage I or stage II lymphocyte predominant Hodgkin disease.

Who is the study for?

This trial is for young patients with newly diagnosed stage I or II lymphocyte predominant Hodgkin disease (LPHD) without bulk disease. They must have normal liver and kidney function, not be pregnant or breastfeeding unless only observing, agree to use contraception if of reproductive potential, and have no prior chemotherapy or radiotherapy.Check my eligibility

What is being tested?

The study tests the effectiveness of surgery alone or combined with chemotherapy drugs like doxorubicin hydrochloride, prednisone, cyclophosphamide, vincristine sulfate and/or radiation therapy in treating LPHD. The goal is to determine which treatment kills more cancer cells.See study design

What are the potential side effects?

Potential side effects include damage to organs from radiation therapy; heart issues; nausea, vomiting from chemotherapy; increased risk of infections due to weakened immune system; hair loss; fatigue; and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have not had any radiotherapy before.

Select...

I have been newly diagnosed with LPHD and haven't received any treatment.

Select...

My cancer is in the early stage and hasn't grown large.

Select...

My cancer is at an early stage and has not formed a large tumor.

Select...

I agree not to breastfeed if I receive chemotherapy or radiation.

Select...

My creatinine level is not above 1.5 mg/dL.

Select...

My creatinine level is not above 1.2 mg/dL, and I am between 10 to 12 years old.

Select...

My LPHD diagnosis follows specific international standards.

Select...

My creatinine level is not above 1.0 mg/dL, and I am between 6 and 9 years old.

Select...

I have not had chemotherapy before.

Select...

My child's creatinine level is not above 0.8 mg/dL.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 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

Failure-free Survival (FFS)

Secondary outcome measures

Cure by AV-PC x 3 or AV-PC x 3 + IFRT for Stage I Unresected, Stage I Resected Whose Disease Recurred, and Stage II Patients

Cure by Surgery Alone in Stage I Resected Patients

Event-free Survival

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (surgery, combination chemotherapy, radiotherapy)Experimental Treatment6 Interventions

COMBINATION CHEMOTHERAPY: Patients receive doxorubicin hydrochloride IV over 10-30 minutes and cyclophosphamide IV over 1 hour on day 1, vincristine IV over 1 minute on days 1 and 8, and prednisone PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiotherapy. IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cortisone

Not yet FDA approved

Doxorubicin

FDA approved

Conventional Surgery

2006

Completed Phase 3

~1080

Vincristine

FDA approved

Cyclophosphamide

FDA approved

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor

453 Previous Clinical Trials

237,512 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,965 Total Patients Enrolled

Burton Appel, MDPrincipal InvestigatorChildren's Oncology Group

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00107198 — Phase 2

Frequently Asked Questions

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

Does the FDA officially sanction radiation therapy?

"A rating of 2 was assigned to Radiation Therapy due to limited clinical data demonstrating its safety. No studies have yet been conducted that demonstrate efficacy."

Answered by AI

Are there any vacancies available for prospective participants of this clinical trial?

"This trial is no longer accepting participants. It was first listed on February 1st 2006 and most recently updated in July 12th 2022. If you are seeking a medical study, 1723 trials for patients with hodgkin disease or 1176 Radiation Therapy studies remain open to join."

Answered by AI

In what geographical locations is this research initiative active?

"At present, this trial is running in 100 medical centres throughout the USA such as Oakland, Kansas City and New Orleans. To reduce travel needs during participation, it's best to select a clinic near you."

Answered by AI

Does this trial represent a unique undertaking in the field?

"Since 1997, Radiation Therapy has been examined in clinical trials with the initial study sponsored by Alfacell. This Phase 3 medication was approved after a trial involving 300 participants and is now being studied across 74 nations within 2769 cities with 1176 active studies."

Answered by AI

What conditions are typically treated with Radiation Therapy?

"Radiation Therapy is regularly used to treat lung cancer, yet it has also proven effective in treating other ailments such as small cell lung cancer (sclc), thyroiditis, and neuroblastoma (nb)."

Answered by AI

To what extent have previous investigations explored the use of Radiation Therapy?

"Currently, 1176 studies are underway that research the effects of Radiation Therapy. Of those trials, 254 have reached Phase 3 and 45498 locations across the globe offer this form of treatment to patients. Philadelphia Pennsylvania is a hub for such clinical data collection efforts."

Answered by AI

Does the protocol for this research endeavor allow participants of an advanced age?

"This trial is open to applicants between 1 Month and 21 years of age. In comparison, there are 667 trials for minors and 2477 clinical studies available to participants over 65."

Answered by AI

Does my profile fit the criteria to participate in this clinical investigation?

"This research project is seeking a cohort of 188 individuals between one month and 21 years old who have been clinically diagnosed with Hodgkin's disease. Acceptable candidates must meet the following criteria: Diagnosis determined through WHO/REAL classification, Stage IA without bulk; no 'B' symptoms or mass lesions, SGOT/SGPT levels lower than 2.5x ULN, Bilirubin below 1.5x ULN, Creatinine clearance at least 70mL/min (or Radioisotope GFR); Serum Uric Acid 0.4-0.5 mg/dL depending on age bracket)."

Answered by AI

How many participants are currently enlisted in this research study?

"Unfortunately, this study has closed its recruitment period. It was initially published on January 2nd 2006 and last edited on July 12th 2022. Nevertheless, 1723 studies related to Hodgkin Disease are presently welcoming participants and 1176 trials involving Radiation Therapy require more volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treating Young Patients With Newly Diagnosed, Low Stage, Lymphocyte Predominant Hodgkin Disease

2006. "Treating Young Patients With Newly Diagnosed, Low Stage, Lymphocyte Predominant Hodgkin Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00107198.

All > Childhood Leukemia