radiation therapy for Hodgkin Disease

Phase-Based Estimates
1
Effectiveness
2
Safety
Lucile Packard Children's Hospital Stanford University, Palo Alto, CA
Hodgkin Disease+4 More
radiation therapy - Radiation
Eligibility
< 65
All Sexes
Eligible conditions
Hodgkin Disease

Study Summary

This study is evaluating whether a combination of chemotherapy, radiation therapy, and a monoclonal antibody can improve the survival of patients with Hodgkin lymphoma.

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Eligible Conditions

  • Hodgkin Disease
  • Lymphoma
  • Stage IV Childhood Hodgkin Lymphoma
  • Stage III Childhood Hodgkin Lymphoma
  • Stage II Childhood Hodgkin Lymphoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether radiation therapy will improve 5 primary outcomes and 17 secondary outcomes in patients with Hodgkin Disease. Measurement will happen over the course of From enrollment to end of therapy (approximately 8 months).

Month 2
Complete Response Rate Estimate for All Evaluable Participants
Month 2
Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control
Month 8
Correlation of agreement between patient QoL and symptom distress to patients treated on HOD 99 unfavorable at multiple time points
To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0)
To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0)
Year 6
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points
Correlation of agreement between patient QoL and parent proxy QoL at multiple time points
Parent Proxy Quality of Life (QoL)
Parent proxy quality of life (QoL)
Patient Quality of Life (QoL)
Patient quality of life (QoL)
Month 8
Descriptive of Hematological Adverse Events
Descriptive of Infectious Adverse Events
Descriptive of Neuropathic Adverse Events
Number of adverse events
Year 3
Comparison of the Event-free (EFS) Survival in High Risk HL Patients Treated With AEPA/CAPDac to the Historical Control HOD99 Unfavorable Risk 2 Arm (UR2).
Event-free survival
Local Failure Rate in High Risk HL Patients Treated With AEPA/CAPDac.
Local failure rate
Month 2
Response rate with PET and CT
Month 2
Response Rate
Response rate

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Treatment

This trial requires 77 total participants across 2 different treatment groups

This trial involves 2 different treatments. Radiation Therapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

TreatmentParticipants receive AEPA regimen (brentuximab vedotin, etoposide, prednisone, doxorubicin), and CAPDac regimen (cyclophosphamide, brentuximab vedotin, prednisone, dacarbazine(R)). Filgrastim may be given as clinically indicated. For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given. Some participants may volunteer to complete the quality of life assessment.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brentuximab vedotin
FDA approved
Cyclophosphamide
FDA approved
Etoposide
FDA approved
Prednisone
FDA approved
Doxorubicin
FDA approved
Filgrastim
FDA approved
radiation therapy
1994
Completed Phase 3
~13030

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment) for reporting.

Closest Location

Lucile Packard Children's Hospital Stanford University - Palo Alto, CA

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
We are conducting a study of people with CD30+ classical Hodgkin lymphoma who have not received treatment before show original
People who are aged 18 years or younger at the time of enrollment are eligible. show original
Ann Arbor stage IIB, IIIB, IVA, or IVB is a cancer that has spread to other parts of the body. show original
Kidneys are adequately functioning if their GFR is 70 ml/min/1.73m^2 or more, or if their serum creatinine is adjusted for age and gender. show original
The child should have adequate hepatic function, which is defined as a total bilirubin level that is less than 1.5 times the upper limit of normal for their age, and an SGOT/SGPT level that is less than 2.5 times the upper limit of normal for their age. show original
A female participant who is post-menarchal must have a negative urine or serum pregnancy test to be eligible to participate in the study. show original
Women or men who may become pregnant must agree to use a form of birth control throughout the course of the study treatment. show original

Patient Q&A Section

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

What are the signs of hodgkin disease?

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Most people presenting with generalized pain to the lymph nodes do not need to have an FNA. There may be other signs that need to be addressed, such as a palpable lymph node and associated signs of lymphadenopathy.

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What causes hodgkin disease?

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The cause(s) of Hodgkin disease are not fully understood even though advances in cancer research and treatment have drastically decreased the mortality rate of this disease. Factors that have been associated with an increased risk include smoking tobacco, being female, exposed to pesticides & radioactive substances, excessive alcohol intake, and immunologic abnormalities. Hodgkin disease causes the body to produce antibodies and it is these antibodies that are the basis of antibody-based immunotherapy treatment. The exact mechanism by which the body reacts to Hodgkin disease is unknown. However, the risk is greater in individuals who have certain genetic predispositions. One such genetic predisposition is a monomorphic (single-celled) chromosomal abnormality called mixed chimerism.

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Can hodgkin disease be cured?

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The majority of patients with untreated HD could be cured. The patients' overall response was similar in both studies. Treatment may have been more effective in the second study, possibly due to the more aggressive treatment of HD in this study, which might have resulted in fewer late effects. Clinical trials show that patients tend to benefit from aggressive treatment.

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What are common treatments for hodgkin disease?

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In spite of the fact that radiotherapy is the first choice treatment for Hodgkin Disease, it often fails to eradicate the disease. Chemotherapy and other chemotherapy-based therapies are used in case of complete remission after radiotherapy.

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How many people get hodgkin disease a year in the United States?

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About 5,800 people will be diagnosed with HL in the United States this year. The overall five-year incidence for all forms of HL is about 1.44 per 100,000 person-years. The incidence by race, sex and age was: 0.46 for Caucasians, 0.77 for blacks, 1.01 for Hispanics and 2.24 for elderly men. The overall five-year mortality was 5.1%. The incidence and mortality were significantly higher for people 45 years of age and older. These estimates for HL are very similar to the estimates for non-Hodgkin lymphoma, because HLs and non-Hodgkin lymphomas are closely related.

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What is hodgkin disease?

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Hodgkin disease is a type of lymphoma that typically manifests in men under the age of 30 and can cause various types of symptoms such as fever, night sweats, and pain in all joints and skin. It typically occurs in the nodal lymph nodes as lymph nodes filled with cancerous cells, but can appear in the bloodstream as a type of blood cancer where it is called a primary lymphocytosis.

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How serious can hodgkin disease be?

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Hodgkin disease is a cause of fatal acute lymphoblastic leukaemia and is considered to be a rare cause of non-Hodgkin lymphoma. The outcome of chronic lymphocytic leukaemia depends on the stage of Hodgkin disease; however acute lymphoblastic leukaemia occurring during the acute phase of Hodgkin disease has been associated with death. The prognosis is good in patients who are treated with high dose therapy and consolidation with autologous stem cell transplantation for all stages. In patients who are progressing on standard treatments, the chance of cure is extremely low. Hence, in the absence of curative drugs, the disease carries a poor prognosis.

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Does radiation therapy improve quality of life for those with hodgkin disease?

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Radiotherapy given during the earlier part of treatment was not related to any significant improvement in self-reported QOL or overall health among those treated with ATG, except for reductions in side effects. Patients treated with ATG reported fewer severe and more moderate dermatologic/ cutaneous adverse effects compared with those not treated with ATG.

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How does radiation therapy work?

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Radiation chemotherapy and radiotherapy are commonly used therapies for Hodgkin disease. These therapies can be efficacious for patients with disease at stage I and II-III. This disease is typically cured without compromising functional outcome or delaying the eventual need for surgery. Radiation therapy for patients with advanced disease is not as effective nor as well tolerated as for patients with early disease.

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Does hodgkin disease run in families?

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This exploratory study suggests that siblings with Hodgkin disease may share a heightened risk for the disease and have more extensive involvement of the hematogenous tract in their disease, although the data suggest that the heightened risk is not genetic. Further investigations would be interesting to gain a better understanding of the mechanisms of disease development in sporadic vs nonfamilial cases.

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Has radiation therapy proven to be more effective than a placebo?

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Radiation therapy improves overall and freedom from progression OS and PFS compared with a placebo treatment. Treatment is also better than a standard systemic therapy or observation alone. Given these results, all patients with stage III Hodgkin's disease should be offered treatment with radiation. A combination with chemotherapy is effective, but the optimal combination remains to be established.

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Have there been other clinical trials involving radiation therapy?

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Radiation therapy has been evaluated in several clinical trials. However studies have varied significantly in terms of radiation dosage, number of treatments, duration of therapy and end points of interest. More studies exploring the best treatment of radiation for Hodgkin disease must be conducted.

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