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Combination Chemotherapy in Treating Younger Patients With Hodgkin Lymphoma

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00666484
Enrollment
47
Registered
2008-04-25
Start date
2008-03-31
Completion date
2012-09-30
Last updated
2014-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, Neurotoxicity

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

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.

Interventions

DRUGcyclophosphamide
DRUGdoxorubicin hydrochloride
DRUGetoposide
DRUGprednisolone
DRUGprocarbazine hydrochloride
DRUGvincristine sulfate
RADIATIONradiation therapy

Sponsors

University College, London
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * 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

Design outcomes

Primary

MeasureTime frame
Neurotoxicity due to the intensive use of Vinca alkaloidsEnd of treatment

Secondary

MeasureTime frame
Response rateEnd of treatment
Disease-free survivalNot specified in protocol
Overall survivalNot specified in protocol
Gonadal toxicityNot specified in protocol

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026