Clinical trial NCT00666484: Combination Chemotherapy in Treating Younger Patients With Hodgkin Lymphoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2008-04-25
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Neurotoxicity due to the intensive use of Vinca alkaloids
timeFrame: End of treatment
Secondary outcomes:
measure: Response rate
timeFrame: End of treatment
measure: Disease-free survival
timeFrame: Not specified in protocol
measure: Overall survival
timeFrame: Not specified in protocol
measure: Gonadal toxicity
timeFrame: Not specified in protocol
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Cancer Centre at St. James's University Hospital
state: England
city: London
country: United Kingdom
facility: University College Hospital - London
state: England
city: London
country: United Kingdom
facility: King's College Hospital
state: England
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Northern Centre for Cancer Treatment at Newcastle General Hospital
state: England
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre at Mount Vernon Hospital
state: England
Study officials:
affiliation: University College London Hospitals
name: Kirit Ardeshna
role: PRINCIPAL_INVESTIGATOR
References: