Combination Chemotherapy in Treating Younger Patients With Hodgkin Lymphoma

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00666484
• Other study ID #: CDR0000593560
• Secondary ID: UCL/07/0052007-0
• Status: Completed
• Phase: Phase 2
• First received: April 24, 2008
• Last updated: December 3, 2014
• Start date: March 2008
• Est. completion date: September 2012

Study information

• Verified date: December 2014
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Neurotoxicity
• Neurotoxicity Syndromes

Intervention

Drug:
• cyclophosphamide

• doxorubicin hydrochloride

• etoposide

• prednisolone

• procarbazine hydrochloride

• vincristine sulfate

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	King's College Hospital	London	England
United Kingdom	University College Hospital - London	London	England
United Kingdom	Northern Centre for Cancer Treatment at Newcastle General Hospital	Newcastle-Upon-Tyne	England
United Kingdom	Mount Vernon Cancer Centre at Mount Vernon Hospital	Northwood	England

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurotoxicity due to the intensive use of Vinca alkaloids		End of treatment	Yes
Secondary	Response rate		End of treatment	No
Secondary	Disease-free survival		Not specified in protocol	No
Secondary	Overall survival		Not specified in protocol	No
Secondary	Gonadal toxicity		Not specified in protocol	Yes