Combination Chemotherapy in Treating Younger Patients With Hodgkin Lymphoma
Status and phase
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Study type
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Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
47 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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