Combination Chemotherapy in Treating Younger Patients With Hodgkin Lymphoma
Condition: Lymphoma; Neurotoxicity
MeSH terms: Lymphoma; Hodgkin Disease; Neurotoxicity Syndromes
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): cyclophosphamide; doxorubicin hydrochloride; etoposide; prednisolone; procarbazine hydrochloride; vincristine sulfate; radiation therapy
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Radiation
Intervention MeSH terms: Prednisolone; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Etoposide; Vincristine; Procarbazine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neurotoxicity; stage I adult Hodgkin lymphoma; stage II adult Hodgkin lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; adult lymphocyte depletion Hodgkin lymphoma; adult lymphocyte predominant Hodgkin lymphoma; adult mixed cellularity Hodgkin lymphoma; adult nodular sclerosis Hodgkin lymphoma