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Completed

NCT Number: NCT00666484

Combination Chemotherapy in Treating Younger Patients With Hodgkin Lymphoma

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclophosphamide

Drug

Doxorubicin hydrochloride

Drug

etoposide

Drug

Prednisolone

Drug

procarbazine hydrochloride

Drug

vincristine sulfate

Drug

radiation therapy

Radiation

Primary outcomes

  1. Neurotoxicity due to the intensive use of Vinca alkaloids

    Time frame: End of treatment

Secondary outcomes

  1. Response rate

    Time frame: End of treatment

  2. Disease-free survival

    Time frame: Not specified in protocol

  3. Overall survival

    Time frame: Not specified in protocol

  4. Gonadal toxicity

    Time frame: Not specified in protocol

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Apr 25, 2008
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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