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

University College, London5 sites in 1 country47 target enrollmentMarch 2008

Interventionsdoxorubicin hydrochloride etoposide prednisolone vincristine sulfate radiation therapy cyclophosphamide procarbazine hydrochloride

Drugscyclophosphamide doxorubicin hydrochloride etoposide prednisolone procarbazine hydrochloride vincristine sulfate

Overview

Phase: Phase 2
Intervention: doxorubicin hydrochloride
Conditions: Lymphoma
Sponsor: University College, London
Enrollment: 47
Locations: 5
Primary Endpoint: Neurotoxicity due to the intensive use of Vinca alkaloids
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

September 2012

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University College, London

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided