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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
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.
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.
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 belowSelect...
I have not had any radiotherapy before.
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I have been newly diagnosed with LPHD and haven't received any treatment.
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My cancer is in the early stage and hasn't grown large.
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My cancer is at an early stage and has not formed a large tumor.
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I agree not to breastfeed if I receive chemotherapy or radiation.
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My creatinine level is not above 1.5 mg/dL.
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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.
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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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Failure-free Survival (FFS)
Secondary study objectives
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
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
Vincristine
FDA approved
Doxorubicin
FDA approved
Conventional Surgery
2006
Completed Phase 3
~1080
Cyclophosphamide
FDA approved
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
Children's Oncology GroupLead Sponsor
457 Previous Clinical Trials
239,642 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,868 Previous Clinical Trials
41,010,649 Total Patients Enrolled
Burton Appel, MDPrincipal InvestigatorChildren's Oncology Group
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had any radiotherapy before.I have been newly diagnosed with LPHD and haven't received any treatment.My cancer is in the early stage and hasn't grown large.My cancer is at an early stage and has not formed a large tumor.I agree not to breastfeed if I receive chemotherapy or radiation.I am a woman who can have children and have a negative pregnancy test before starting treatment.I haven't taken systemic corticosteroids in the last 30 days.My creatinine level is not above 1.5 mg/dL.I am pregnant or breastfeeding, have stage I cancer with one lymph node involved, and had a complete surgery.I agree to use effective birth control during my chemotherapy or radiation treatment.My creatinine level is not above 1.2 mg/dL, and I am between 10 to 12 years old.My LPHD diagnosis follows specific international standards.My kidney function is appropriate for my age and gender.My condition is at a specific stage.My creatinine level is not above 1.0 mg/dL, and I am between 6 and 9 years old.I have not had chemotherapy before.My child's creatinine level is not above 0.8 mg/dL.
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