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Hodgkin Lymphoma

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Anti-Infective Agents

Etoposide

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Prednisone

Vincristine

Lenograstim

Etoposide phosphate

Mitogens

Bleomycin

Vinblastine

Dacarbazine

Procarbazine

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Alkylating Agents

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Antibiotics, Antitubercular

Enzyme Inhibitors

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Antimitotic Agents

Patients receive 4 cycles of BEACOPP therapy. Drugs utilized in this regimen include Bleomycin (B), Etoposide (E), Doxorubicin (A), Cyclophosphamide (C), Vincristine (O), Prednisone (P) and Procarbazine (P). Each cycle lasts 21 days and is characterized by intravenous pulses of Etoposide (Days 0-2), Doxorubicin (Day 0), Cyclophosphamide (Day 0), Bleomycin (Day 7), Vincristine (Day 7). Seven days of oral procarbazine (Days 0-6) and 14 days of oral prednisone (Days 0-13) are given during each cycle.

Growth factor support with Filgrastim (G-CSF) is given by subcutaneous injection daily beginning Day 8. Response will then be determined and stratification for further treatment.

bleomycin sulfate

filgrastim

ABVD regimen

cyclophosphamide

dacarbazine

doxorubicin hydrochloride

etoposide

prednisone

procarbazine hydrochloride

vinblastine sulfate

vincristine sulfate

radiation therapy

Kara Kelly, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Giving radiation therapy after chemotherapy may be an effective treatment for Hodgkin's disease.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating children who have previously untreated stage II, stage III, or stage IV Hodgkin's disease.

OBJECTIVES: I. Determine the feasibility and toxicity of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP) induction in pediatric patients with previously untreated stage II, stage III, or stage IV Hodgkin's disease. II. Determine rates of complete response and rapid early partial response (defined as greater than 70% reduction in the size of a bulky mediastinal mass or nodal aggregate and a negative gallium scan) in these patients treated with 4 courses of BEACOPP. III. Determine whether thallium scans effectively measure response to therapy in these patients treated with this regimen. IV. Evaluate the expression of markers of apoptosis in tumor samples from these patients at diagnosis and at time of relapse, and correlate expression of these markers with response to therapy and overall outcome. V. Determine the utility of seven molecular genetic markers as surrogate markers of genotoxic damage caused by this regimen in these patients. VI. Estimate the incidence of therapy related late effects, including second malignant neoplasms, sterility, cardiac dysfunction, pulmonary restrictive disease, growth abnormalities, and thyroid disease in these patients.

OUTLINE: Induction: On day 0, patients receive cyclophosphamide IV over 30 minutes, doxorubicin IV over 15-30 minutes, etoposide IV over 1 hour, oral prednisone every 12 hours, and oral procarbazine. On days 1 and 2, patients receive etoposide IV over 1 hour, oral prednisone every 12 hours, and oral procarbazine. On days 3-6, patients receive oral prednisone every 12 hours and oral procarbazine. On day 7, patients receive vincristine IV, bleomycin IV over 5 minutes, and oral prednisone every 12 hours. On days 8-13, patients receive oral prednisone every 12 hours. Beginning on day 8, patients receive filgrastim (G-CSF) subcutaneously until absolute neutrophil counts recover. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Consolidation therapy begins on week 12 or when blood counts recover. Consolidation for rapid early responders (patients with complete response (CR) or rapid early partial response (PR-1) to induction therapy): Females - Patients receive vincristine IV, cyclophosphamide IV over 30 minutes, oral prednisone every 12 hours, and oral procarbazine on day 0. On days 1-6, patients receive oral prednisone every 12 hours and oral procarbazine. On day 7, patients receive vinblastine IV, bleomycin IV over 5 minutes, doxorubicin IV over 15-30 minutes, and oral prednisone every 12 hours. On days 8-13, patients receive oral prednisone every 12 hours. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Males - Patients receive doxorubicin IV over 15-30 minutes, bleomycin IV over 5 minutes, vinblastine IV, and dacarbazine IV on days 0 and 14. Treatment repeats every 28 days for a total of 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3 weeks after completion of chemotherapy, male patients with CR or PR-1 receive radiotherapy 5 days per week to areas of initial disease involvement (total duration of radiotherapy is dependent on initial extent of disease). Consolidation for slow early responders: Patients with slow partial response (PR-2) or stable disease (SD) after 4 courses of induction therapy receive 4 additional courses of induction therapy in the absence of disease progression or unacceptable toxicity. Beginning on day 8, patients receive G-CSF subcutaneously until blood counts recover. Patients should be off G-CSF for more than 24 hours prior to the next course of chemotherapy. Beginning 3 weeks after completion of chemotherapy, male and female patients with PR-2 or SD receive radiotherapy 5 days per week to areas of initial disease involvement (total duration of radiotherapy is dependent on initial extent of disease). Patients are followed every 3 months for 2 years, every 6 months for 1 year, annually for 2 years and then at years 10 and 20.

PROJECTED ACCRUAL: Approximately 25-50 patients will be accrued for this study.

Combination Chemotherapy and Radiation Therapy in Treating Children With Previously Untreated Stage II, Stage III, or Stage IV Hodgkin's Disease

Pilot Study for the Treatment of Children With Newly Diagnosed Advanced Stage Hodgkin's Disease: Upfront Dose Intensive Chemotherapy

National Cancer Institute (NCI)

Children's Oncology Group

microarray analysis

protein expression analysis

immunohistochemistry staining method

laboratory biomarker analysis

Frank G. Keller, MD

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research trial is studying protein biomarker levels in tissue samples from young patients with low-risk Hodgkin lymphoma.

OBJECTIVES:

* To investigate the variability of expression of human geminal-center-associated lymphoma (HGAL) protein in pediatric low-risk Hodgkin lymphoma.
* To assess the variability of HGAL staining between risk groups by comparing samples from subjects enrolled in the low-risk study AHOD0431 with subject samples enrolled in AHOD0031 for intermediate-risk classical Hodgkin Lymphoma (cHL).
* To assess the variability of HGAL staining by evaluating a tissue array created from subjects with intermediate-risk cHL.
* To correlate rapid or slow early-response in the intermediate-risk group with HGAL protein expression.

OUTLINE: Paraffin-embedded tissue samples and tissue microarrays are analyzed for protein expression by IHC.

Protein Biomarker Levels in Tissue Samples From Young Patients With Low-risk Hodgkin Lymphoma

Investigation to Evaluate the Levels of Human Germinal-center-Associated Lymphoma (HGAL) Protein in Pediatric Hodgkin Lymphoma and Correlate With Early Response

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Fluorodeoxyglucose F18

Prednisolone

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Radiopharmaceuticals

procarbazine-containing consolidation chemotherapy arm

procarbazine-free consolidation chemotherapy arm

drug is used in first line treatment in combination (COPP or COPDAC)

drug is used in first line treatment in combination (COPDAC)

drug is used in first line treatment in combination (OEPA, COPP or COPDAC)

prednisolone

drug is used in first line treatment in combination (COPP)

used as a diagnostic marker for metabolically active tumour at staging and response assessment

fludeoxyglucose F 18

part of combination treatment (combined modality between chemo- and radiotherapy)

Dieter Koerholz, MD

W. Hamish Wallace, MD

Judith Landman-Parker, MD

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to compare how well they work in treating young patients with Hodgkin's lymphoma.

OBJECTIVES:

Primary

* Determine whether the 5-year event-free survival (EFS) rate in pediatric patients with Hodgkin's lymphoma with an adequate response after 2 courses of vincristine, etoposide, prednisone, and doxorubicin hydrochloride (OEPA) (without radiotherapy) are consistent with an estimated target EFS rate of 90%.
* Compare the EFS (without a deterioration) of patients treated with procarbazine hydrochloride vs dacarbazine (treatment groups 2 and 3).
* Determine the treatment outcome of a standardized risk-adapted relapse strategy in these patients.

Secondary

* Determine whether the 5-year EFS rate in patients with Hodgkin's lymphoma with an inadequate response after 2 OEPA courses and standard involved-field radiotherapy are consistent with an estimated target EFS rate of 90%.
* Determine whether a positive positron emission tomography scan before planned high-dose chemotherapy with autologous stem cell transplantation has a negative prognostic significance.
* Compare the effect of dacarbazine vs procarbazine on the rate of infertility in males and premature menopause in females (treatment groups 2 and 3).

Tertiary

* Determine the impact of real-time central staging and response assessment on treatment outcome in these patients.

OUTLINE: This is a randomized, controlled, parallel-group, open-label, multicenter study. Patients are stratified according to staging and response assessment (central vs local) and disease stage (IA/B or IIA \[first-line treatment group 1\] vs I_EA/B, II_EA, IIB, or IIIA \[first-line treatment group 2\] vs II_EB, III_E A/B, IIIB, or IVA/B \[first-line treatment group 3\]).

* First-line treatment group 1: Patients receive oral prednisone (or prednisolone) 3 times daily on days 1-15, vincristine IV on days 1, 8, and 15, doxorubicin hydrochloride IV over 1-6 hours on days 1 and 15, and etoposide (or etoposide phosphate) IV over 1-2 hours on days 1-5 (OEPA).

Treatment repeats every 28 days for 2 courses in the absence of unacceptable toxicity. Patients are assessed by fludeoxyglucose F 18 positron emission tomography (\^18FDG-PET) scan. Patients with inadequate response undergo radiotherapy within 35 days after completion of OEPA.

* First-line treatment group 2: Patients receive OEPA as in group 1. After completion of OEPA, patients are randomized to 1 of 2 treatment arms.

  * Arm I: Patients receive oral prednisone (or prednisolone) 3 times daily and oral procarbazine hydrochloride 2-3 times a day on days 1-15 and vincristine IV and cyclophosphamide IV over 1 hour on days 1 and 8 (COPP).
  * Arm II: Patients receive oral prednisone (or prednisolone) 3 times daily on days 1-15, dacarbazine IV over 15-30 minutes on days 1-3, and vincristine IV and cyclophosphamide IV over 1 hour on days 1 and 8 (COPDAC).

In both arms, treatment repeats every 28 days for 2 courses in the absence of unacceptable toxicity. Patients are assessed by \^18FDG-PET scan. Patients with an inadequate response undergo radiotherapy within 35 days after completion of COPP or COPDAC.

* First-line treatment group 3: Patients receive OEPA as in group 1. After completion of OEPA, patients are randomized to 1 of 2 treatment arms.

  * Arm I: Patients receive COPP as in arm I of group 2.
  * Arm II: Patients receive COPDAC as in arm II of group 2. In both arms, treatment repeats every 28 days for 4 courses in the absence of unacceptable toxicity. Patients are assessed by \^18FDG-PET scan. Patients with an inadequate response undergo radiotherapy within 35 days after completion of COPP or COPDAC.

Patients with biopsy-confirmed disease progression OR relapse after first-line treatment on this study or on protocols DAL-HD 90, GPOH-HD 95, GPOHHD 2002 Pilot, or similar treatment proceed to second-line therapy. Patients are stratified according to relapse/progression status (late relapse from first-line treatment group 1 \[second-line treatment group 1\] vs early relapse from first-line treatment groups 1, 2, or 3 or late relapse from first-line treatment groups 2 or 3 \[second-line treatment group 2\] vs disease progression \[second-line treatment group 3\]). Patients undergo a \^18FDG-PET scan prior to beginning second-line therapy.

* Second-line treatment group 1: Patients receive ifosfamide IV over 22 hours and etoposide IV over 1-2 hours and oral prednisone three times daily on days 1-5 (IEP). Patients then receive doxorubicin hydrochloride IV over 1-6 hours, bleomycin IV, vinblastine IV, and dacarbazine IV over 15-30 minutes on days 22 and 36 (ABVD). Treatment repeats every 50 days for 2 courses in the absence of disease progression or unacceptable toxicity.

After chemotherapy treatment, patients undergo radiotherapy.

* Second-line treatment group 2: Patients receive IEP and ABVD as in group 1. Autologous stem cells are collected after course 1 or 2 of IEP/ABVD.

After chemotherapy, patients with an adequate response undergo radiotherapy. Patients with an inadequate response undergo high-dose chemotherapy comprising carmustine IV over 1-2 hours on day -7, etoposide IV and cytarabine IV over 30 minutes twice daily on days -6 to -3, and melphalan IV over 1½ hours on day -2. Patients then undergo autologous hematopoietic stem cell transplantation (HSCT).

Patients undergo a \^18FDG-PET scan on day 50-54. Patients with \^18FDG-PET scan positive disease undergo radiotherapy.

* Second-line treatment group 3: Patients receive IEP and ABVD as in group 1. All patients then undergo high-dose chemotherapy and HSCT as in group 2.

Patients undergo a \^18FDG-PET scan on day 50-54. Patients with \^18FDG-PET scan positive disease undergo radiotherapy.

After completion of study therapy, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 2,150 patients will be accrued for this study.

Combination Chemotherapy in Treating Young Patients With Hodgkin's Lymphoma

First International Inter-Group Study for Classical Hodgkin's Lymphoma in Children and Adolescents

Deutsche Krebshilfe e.V., Bonn (Germany)

Euronet Worldwide

Christine Mauz-Körholz

Prof. Dr. med. Christine Mauz-Körholz

Hematinics

Iron-Dextran Complex

dose and time intensified consoloditation chemotherapy cycle

1250 mg/m2 i.v. 60 Min.-Inf. day 1 and 21

25mg/m²/day, 2 hours i.v.infusion on day 21

150 mg/m²/day, 2 hours i.v.infusion (intravenous drip) on days 1 - 3

40 mg/m2/day p.o. (intake by mouth)divided in 3 single doses daily from day 1 - 14 and day 21 - 34

1,5 mg/m2 i.v. bolus max. single dose 2 mg (cap dose at 2 mg) on day 8 and day 29

involved field irradiation, single daily fractions 1,5 Gy to max. 1,8 Gy standard dose 20 Gy, max dose 30 Gy (boost irradiation if required)

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying the side effects and how well combination chemotherapy works in treating young male patients with Hodgkin's lymphoma.

OBJECTIVES:

* Determine the safety and efficacy of combination chemotherapy comprising vincristine, etoposide, cyclophosphamide, vinblastine, prednisone, and doxorubicin hydrochloride (VECOPA) in pediatric male patients with previously untreated stage II-IV classic Hodgkin's lymphoma.
* Compare the effects of VECOPA vs cyclophosphamide, vincristine, procarbazine hydrochloride, and prednisone (COPP) in these patients.

OUTLINE: This is a pilot, multicenter study. Patients are stratified according to disease stage (IA/B\[E\], IIA\[E\], IIB, or IIIA vs IIB\[E\], IIIA/B\[E\], IIIB, or IVA/B).

* Stratum 1 (stages IA/B\[E\], IIA\[E\], IIB, or IIIA): Patients receive oral prednisone on days 1-15, vincristine IV on days 1, 8, and 15, doxorubicin hydrochloride IV over 4 hours on days 1 and 15, and etoposide IV over 2 hours on days 2-6 (OEPA). Treatment repeats every 4 weeks for 2 courses. Beginning at week 9, patients receive VECOPA chemotherapy comprising oral prednisone on days 1-14 and 21-34, etoposide IV over 2 hours on days 1-3, doxorubicin hydrochloride IV over 2 hours on day 21, vinblastine IV and cyclophosphamide IV over 1 hour on days 1 and 21, and vincristine IV on days 8 and 29. Patients then undergo radiotherapy.
* Stratum 2 (stages IIB\[E\], IIIA/B\[E\], IIIB, or IVA/B): Patients receive 2 courses of OEPA as in stratum 1 followed by 2 courses of VECOPA (6-week courses). Patients then undergo radiotherapy.

After completion of study treatment, patients are followed periodically for at least 6 years.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Combination Chemotherapy in Treating Young Male Patients With Hodgkin's Lymphoma

Pilot Study for Therapy Optimising for Hodgkin's Lymphoma in Childhood and Adolescence; Optimising Therapy for Boys With Hodgkin's Lymphoma in Intermediate and Advanced Stages. Safety and Efficacy Study for Drug Combination VECOPA

number of VECOPA cycles that allow continuation of chemotherapy on a sufficient hematopoietic recovery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combination Chemotherapy and Radiation Therapy in Treating Children With Previously Untreated Stage II, Stage III, or Stage IV Hodgkin's Disease	NCT00004010	Lymphoma	bleomycin sulfa... filgrastim ABVD regimen cyclophosphamid... dacarbazine doxorubicin hyd... etoposide prednisone procarbazine hy... vinblastine sul... vincristine sul... radiation thera...	- 21 Years	Children's Oncology Group
Protein Biomarker Levels in Tissue Samples From Young Patients With Low-risk Hodgkin Lymphoma	NCT01366157	Lymphoma	microarray anal... protein express... immunohistochem... laboratory biom...	- 21 Years	Children's Oncology Group
Combination Chemotherapy in Treating Young Patients With Hodgkin's Lymphoma	NCT00433459	Lymphoma	cyclophosphamid... dacarbazine prednisolone prednisone procarbazine hy... vincristine sul... fludeoxyglucose... radiation thera...	- 17 Years	Martin-Luther-Universität Halle-Wittenberg
Protein Biomarker Levels in Tissue Samples From Young Patients With Low-risk Hodgkin Lymphoma	NCT01366157	Lymphoma	microarray anal... protein express... immunohistochem... laboratory biom...	- 21 Years	Children's Oncology Group
Combination Chemotherapy and Radiation Therapy in Treating Children With Previously Untreated Stage II, Stage III, or Stage IV Hodgkin's Disease	NCT00004010	Lymphoma	bleomycin sulfa... filgrastim ABVD regimen cyclophosphamid... dacarbazine doxorubicin hyd... etoposide prednisone procarbazine hy... vinblastine sul... vincristine sul... radiation thera...	- 21 Years	Children's Oncology Group
Combination Chemotherapy in Treating Young Male Patients With Hodgkin's Lymphoma	NCT00398554	Lymphoma	cyclophosphamid... doxorubicin hyd... etoposide prednisone vinblastine sul... vincristine sul... radiation thera...	- 18 Years	Martin-Luther-Universität Halle-Wittenberg

Spots Global Cancer Trial Database for childhood lymphocyte depletion hodgkin lymphoma