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| ID | Type | Description | Link |
|---|---|---|---|
| UCL/07/005 | Other Identifier | University College London | |
| 2007-003080-45 | EudraCT Number | ||
| EU-20844 |
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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. It is not yet known which regimen of combination chemotherapy is more effective for Hodgkin lymphoma.
PURPOSE: This phase II trial is studying the side effects of three different regimens of combination chemotherapy and to see how well they work in treating younger patients with Hodgkin lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are assigned to treatment group according to stage.
In all groups, treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1: stages 1A, 1B, 2A: OEPA x 2 | Experimental | OEPA (28day cycle): Vincristine 1.5mg/m^2 iv d1,d8,d15 (capped at 2mg/dose) Etoposide 125mg/m^2 iv d1-5 Prednisolone 60mg/m^2 po d1-15 Adriamycin 40mg/m^2 iv d1 and 15 |
|
| Treatment Group 2: stages 2AE, 2B, 3A: OEPA x 2 + COPP x 2 | Experimental | OEPA (28 day cycle) Vincristine 1.5mg/m^2 iv d1,d8,d15 (capped at 2mg/dose) Etoposide 125mg/m^2 iv d1-5 Prednisolone 60mg/m^2 po d1-15 Adriamycin 40mg/m^2 iv d1 and 15 COPP (28 day cycle) Cyclophosphamide 500mg/m^2 iv d1 and 8 Vincristine 1.5mg/m^2 iv d1,8 (capped 2mg/dose) Procarbazine 100mg/m^2 po d1-15* Prednisolone 40mg/m^2 po d1-15 |
|
| Treatment Group 3: stages 2BE, 3AE, 3B, 4: OEPAx2 + COPPx4 | Experimental | OEPA (28 day cycle) Vincristine 1.5mg/m^2 iv d1,d8,d15 (capped at 2mg/dose) Etoposide 125mg/m^2 iv d1-5 Prednisolone 60mg/m^2 po d1-15 Adriamycin 40mg/m^2 iv d1 and 15 COPP (28 day cycle) Cyclophosphamide 500mg/m^2 iv d1 and 8 Vincristine 1.5mg/m^2 iv d1,8 (capped 2mg/dose) Procarbazine 100mg/m^2 po d1-15* Prednisolone 40mg/m^2 po d1-15 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclophosphamide | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Neurotoxicity due to the intensive use of Vinca alkaloids | End of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | End of treatment | |
| Disease-free survival | Not specified in protocol | |
| Overall survival |
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DISEASE CHARACTERISTICS:
Biopsy proven de-novo classical Hodgkin lymphoma
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Kirit Ardeshna | University College London Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leeds Cancer Centre at St. James's University Hospital | Leeds | England | LS9 7TF | United Kingdom | ||
| University College Hospital - London |
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| doxorubicin hydrochloride |
| Drug |
|
| etoposide | Drug |
|
| prednisolone | Drug |
|
| procarbazine hydrochloride | Drug |
|
| vincristine sulfate | Drug |
|
| radiation therapy | Radiation |
|
| Not specified in protocol |
| Gonadal toxicity | Not specified in protocol |
| London |
| England |
| NW1 2PG |
| United Kingdom |
| King's College Hospital | London | England | SE5 9RS | United Kingdom |
| Northern Centre for Cancer Treatment at Newcastle General Hospital | Newcastle upon Tyne | England | NE4 6BE | United Kingdom |
| Mount Vernon Cancer Centre at Mount Vernon Hospital | Northwood | England | HA6 2RN | United Kingdom |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D020258 | Neurotoxicity Syndromes |
| 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 |
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D005047 | Etoposide |
| D011239 | Prednisolone |
| D011344 | Procarbazine |
| 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 |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D001549 | Benzamides |
| D000577 | Amides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| 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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