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| ID | Type | Description | Link |
|---|---|---|---|
| GPOH-HD-2002-PILOT-VECOPA | |||
| EU-20652 | |||
| EUDRACT-2004-005244-28 |
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| Name | Class |
|---|---|
| Martin-Luther-Universität Halle-Wittenberg | OTHER |
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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:
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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VECOPA | Experimental | dose and time intensified consoloditation chemotherapy cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclophosphamide | Drug | 1250 mg/m2 i.v. 60 Min.-Inf. day 1 and 21 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity at days 21 and 42 (+/- 2 days) of treatment | number of VECOPA cycles that allow continuation of chemotherapy on a sufficient hematopoietic recovery | days 21 and 42 (+/- 2 days) of treatment after start of VECOPA cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival | event-free survival at 5 years | |
| Overall survival | overall survival at 5 years |
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DISEASE CHARACTERISTICS:
Diagnosis of classic Hodgkin's lymphoma (HL)
No lymphocyte-predominant HL
Previously untreated disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Dieter Koerholz, MD | Martin-Luther-Universität Halle-Wittenberg | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Augsburg | Augsburg | D-86156 | Germany | |||
| Charite University Medical Center of Berlin |
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| doxorubicin hydrochloride |
| Drug |
25mg/m²/day, 2 hours i.v.infusion on day 21 |
|
| etoposide | Drug | 150 mg/m²/day, 2 hours i.v.infusion (intravenous drip) on days 1 - 3 |
|
| prednisone | Drug | 40 mg/m2/day p.o. (intake by mouth)divided in 3 single doses daily from day 1 - 14 and day 21 - 34 |
|
| vinblastine sulfate | Drug | 6 mg/m² i.v. bolus on day 1 and day 21 |
|
| vincristine sulfate | Drug | 1,5 mg/m2 i.v. bolus max. single dose 2 mg (cap dose at 2 mg) on day 8 and day 29 |
|
| radiation therapy | Radiation | 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) |
|
| Berlin |
| D-13347 |
| Germany |
| Medizinische Universitaetsklinik I at the University of Cologne | Cologne | D-50924 | Germany |
| Universitaets - Kinderklinik | Erlangen | 91054 | Germany |
| Universitaetsfrauenklinik Frankfurt | Frankfurt | D-60596 | Germany |
| Universitaetsklinikum Halle | Halle | D-06097 | Germany |
| Medizinische Hochschule Hannover | Hanover | D-30625 | Germany |
| Universitaets - Kinderklinik | Leipzig | D-04317 | Germany |
| Kinderklinik d. TU / Schwabing | Munich | 80804 | Germany |
| Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster | Münster | D-48149 | Germany |
| Klinikum Oldenburg | Oldenburg | D-26133 | Germany |
| University Children's Hospital | Zurich | CH-8032 | Switzerland |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D005047 | Etoposide |
| D011241 | Prednisone |
| D014747 | Vinblastine |
| D014750 | Vincristine |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D013812 | Therapeutics |
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