Combination Chemotherapy in Treating Younger Patients With Hodgkin Lymphoma
NCT ID: NCT00666484
Last Updated: 2014-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
47 participants
INTERVENTIONAL
2008-03-31
2012-09-30
Brief Summary
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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.
Detailed Description
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Primary
* To establish neurotoxicity of OEPA+COPP chemotherapy in young adults.
Secondary
* To determine response rates in patients treated with this regimen.
* To determine disease-free survival of patients treated with this regimen.
* To determine overall survival of patients treated with this regimen.
* To determine gonadal toxicity in patients treated with this regimen.
OUTLINE: Patients are assigned to treatment group according to stage.
* Group 1 (patients with stage 1A, 1B, or 2A disease): Patients receive OEPA chemotherapy comprising vincristine IV on days 1, 8, and 15; oral prednisolone on days 1-15; etoposide IV on days 1-5; and doxorubicin hydrochloride IV on days 1 and 15. Courses repeat every 28 days for 2 courses. Patients achieving a partial response also undergo radiotherapy after completion of chemotherapy; patients achieving a complete response do not undergo radiotherapy.
* Group 2 (patients with stage 2AE, 2B, or 3A disease): Patients receive 2 courses of OEPA chemotherapy as in group 1. Patients then receive COPP chemotherapy comprising cyclophosphamide IV on days 1 and 8; vincristine IV on days 1 and 8; oral procarbazine hydrochloride on days 1-15; and oral prednisolone on days 1-15. Courses repeat every 28 days for 2 courses. Patients also undergo radiotherapy after completion of chemotherapy.
* Group 3 (patients with stage 2BE, 3AE, 3BE, 3B, 4A, or 4B disease): Patients receive 2 courses of OEPA chemotherapy as in group 1. Patients then receive COPP chemotherapy as in group 2. Treatment with COPP chemotherapy repeats every 28 days for 4 courses. Patients also undergo radiotherapy after completion of chemotherapy.
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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Group 1: stages 1A, 1B, 2A: OEPA x 2
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
doxorubicin hydrochloride
etoposide
prednisolone
vincristine sulfate
radiation therapy
Treatment Group 2: stages 2AE, 2B, 3A: OEPA x 2 + COPP x 2
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
cyclophosphamide
doxorubicin hydrochloride
etoposide
prednisolone
procarbazine hydrochloride
vincristine sulfate
radiation therapy
Treatment Group 3: stages 2BE, 3AE, 3B, 4: OEPAx2 + COPPx4
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
cyclophosphamide
doxorubicin hydrochloride
etoposide
prednisolone
procarbazine hydrochloride
vincristine sulfate
radiation therapy
Interventions
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cyclophosphamide
doxorubicin hydrochloride
etoposide
prednisolone
procarbazine hydrochloride
vincristine sulfate
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Biopsy proven de-novo classical Hodgkin lymphoma
* Any stage disease
* No nodular lymphocyte-predominant Hodgkin lymphoma
PATIENT CHARACTERISTICS:
* No known or suspected HIV infection
* No pre-existing neurological disorder
* No serious comorbidity which may prevent administration of study treatment
* No other previous malignancy
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for up to 1 year after completion of study treatment
* Creatinine ≤ 1.5 times upper limit of normal (ULN) unless due to the lymphoma
* ALT/AST ≤ 1.5 times ULN unless due to the lymphoma
* Bilirubin ≤ 2 times ULN unless due to the lymphoma
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy or radiotherapy
* No prior organ transplant
18 Years
30 Years
ALL
No
Sponsors
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University College, London
OTHER
Responsible Party
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Principal Investigators
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Kirit Ardeshna
Role: PRINCIPAL_INVESTIGATOR
University College London Hospitals
Locations
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Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
University College Hospital - London
London, England, United Kingdom
King's College Hospital
London, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom
Countries
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Other Identifiers
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UCL/07/005
Identifier Type: OTHER
Identifier Source: secondary_id
2007-003080-45
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EU-20844
Identifier Type: -
Identifier Source: secondary_id
CDR0000593560
Identifier Type: -
Identifier Source: org_study_id