Lymphoma
Conditions
Keywords
stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma
Brief summary
RATIONALE: Drugs used in chemotherapy, such as vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells. PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating older patients with previously untreated Hodgkin's lymphoma.
Detailed description
OBJECTIVES: Primary * Determine the efficacy and toxicity of vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin in older patients with Hodgkin's lymphoma. * Determine whether the application of the Hasenclever prognostic index is valid in these patients at diagnosis. OUTLINE: This is an open-label, multicenter study. * Chemotherapy: Patients receive vinblastine IV and cyclophosphamide IV on day 1; oral procarbazine and oral prednisolone on days 1-5; oral etoposide on days 15-19; and mitoxantrone IV and bleomycin IV on day 15. Treatment repeats every 28 days, in the absence of disease progression or unacceptable toxicity, for a total of 3 courses in patients with early (stage IA or IIA) disease or 6 courses in patients with advanced (stage IB or IIB-IV) disease. * Radiotherapy: Patients with early stage disease receive involved-field radiotherapy. Patients with advanced stage disease receive radiotherapy limited to sites of initial bulky disease or residual disease. Radiotherapy begins 4 weeks after the completion of chemotherapy. Patients are followed monthly for 3 months, every 3 months for 6 months, and then annually thereafter. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 36 months.
Interventions
BIOLOGICALbleomycin sulfate
Treatment
DRUGcyclophosphamide
Treatment
DRUGetoposide
Treatment
DRUGmitoxantrone hydrochloride
Treatment
DRUGprednisolone
Treatment
DRUGprocarbazine hydrochloride
Treatment
DRUGvinblastine sulfate
Treatment
Sponsors
Newcastle-upon-Tyne Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
Histologically confirmed classical Hodgkin Lymphoma (HL). No previous treatment for HL. Age ≥ 60. Non fragile patient (see Appendix 1) i.e. patient's mental and physical status must be sufficient to withstand the treatment described. No concomitant neoplasia requiring treatment or known HIV infection. Written informed consent.
Exclusion criteria
Nodular lymphocyte predominance Hodgkin Lymphoma (NLPHL) Age \<60. Patient previously treated for HL. Known HIV infection or concomitant neoplasia. Fragile patient (see Appendix 1) or significant abnormality of another system (pulmonary, cardiac, renal, and hepatic) which is a contraindication to full dose chemotherapy. Unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival by routine imaging | 6 month intervals |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival by routine imaging | 5 years |
Countries
Germany, United Kingdom
Outcome results
None listed