Combination Chemotherapy in Treating Younger Patients With Hodgkin Lymphoma
- Conditions
- NeurotoxicityLymphoma
- Interventions
- Registration Number
- NCT00666484
- Lead Sponsor
- University College, London
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Group 2: stages 2AE, 2B, 3A: OEPA x 2 + COPP x 2 procarbazine hydrochloride 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 procarbazine hydrochloride 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 vincristine sulfate 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 1: stages 1A, 1B, 2A: OEPA x 2 vincristine sulfate 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 1: stages 1A, 1B, 2A: OEPA x 2 radiation therapy 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 vincristine sulfate 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 2: stages 2AE, 2B, 3A: OEPA x 2 + COPP x 2 radiation therapy 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 radiation therapy 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 1: stages 1A, 1B, 2A: OEPA x 2 doxorubicin hydrochloride 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 1: stages 1A, 1B, 2A: OEPA x 2 etoposide 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 doxorubicin hydrochloride 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 1: stages 1A, 1B, 2A: OEPA x 2 prednisolone 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 etoposide 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 2: stages 2AE, 2B, 3A: OEPA x 2 + COPP x 2 cyclophosphamide 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 2: stages 2AE, 2B, 3A: OEPA x 2 + COPP x 2 prednisolone 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 prednisolone 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 cyclophosphamide 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 doxorubicin hydrochloride 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 etoposide 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
- Primary Outcome Measures
Name Time Method Neurotoxicity due to the intensive use of Vinca alkaloids End of treatment
- Secondary Outcome Measures
Name Time Method Response rate End of treatment Disease-free survival Not specified in protocol Overall survival Not specified in protocol Gonadal toxicity Not specified in protocol
Trial Locations
- Locations (5)
University College Hospital - London
🇬🇧London, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, 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