Combination Chemotherapy in Treating Younger Patients With Hodgkin Lymphoma
Recruitment status was Recruiting
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.
Drug: doxorubicin hydrochloride
Drug: procarbazine hydrochloride
Drug: vincristine sulfate
Radiation: radiation therapy
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study Evaluating the Toxicity and Efficacy of a Modified German Paediatric Hodgkin's Lymphoma Protocol (HD95) in Young Adults (Aged 18-30 Years) With Hodgkin's Lymphoma|
- Neurotoxicity due to the intensive use of Vinca alkaloids [ Designated as safety issue: Yes ]
- Response rate [ Designated as safety issue: No ]
- Disease-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Gonadal toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||March 2008|
- To establish neurotoxicity of OEPA+COPP chemotherapy in young adults.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666484
|Leeds Cancer Centre at St. James's University Hospital||Recruiting|
|Leeds, England, United Kingdom, LS9 7TF|
|Contact: Contact Person 44-113-206-7851 firstname.lastname@example.org|
|King's College Hospital||Recruiting|
|London, England, United Kingdom, SE5 9RS|
|Contact: Contact Person 44-20-3299-9000|
|University College Hospital - London||Recruiting|
|London, England, United Kingdom, NW1 2PG|
|Contact: Kirit Ardeshna 44-20-7380-6962 email@example.com|
|Northern Centre for Cancer Treatment at Newcastle General Hospital||Recruiting|
|Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE|
|Contact: Helen H. Lucraft, MD 44-191-256-3565 firstname.lastname@example.org|
|Mount Vernon Cancer Centre at Mount Vernon Hospital||Recruiting|
|Northwood, England, United Kingdom, HA6 2RN|
|Contact: Kirit Ardeshna 44-1923-844-413 email@example.com|
|Principal Investigator:||Kirit Ardeshna||University College London Hospitals|