Combination Chemotherapy in Treating Younger Patients With Hodgkin Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT00666484
First received: April 24, 2008
Last updated: December 3, 2014
Last verified: December 2014

April 24, 2008
December 3, 2014
March 2008
September 2012   (final data collection date for primary outcome measure)
Neurotoxicity due to the intensive use of Vinca alkaloids [ Time Frame: End of treatment ] [ Designated as safety issue: Yes ]
Neurotoxicity due to the intensive use of Vinca alkaloids [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00666484 on ClinicalTrials.gov Archive Site
  • Response rate [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: Not specified in protocol ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Not specified in protocol ] [ Designated as safety issue: No ]
  • Gonadal toxicity [ Time Frame: Not specified in protocol ] [ Designated as safety issue: Yes ]
  • Response rate [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Gonadal toxicity [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lymphoma
  • Neurotoxicity
  • Drug: cyclophosphamide
  • Drug: doxorubicin hydrochloride
  • Drug: etoposide
  • Drug: prednisolone
  • Drug: procarbazine hydrochloride
  • Drug: vincristine sulfate
  • Radiation: radiation therapy
  • Experimental: Treatment Group 1: stages 1A, 1B, 2A: OEPA x 2

    OEPA (28day cycle):

    Vincristine 1.5mg/m^2 iv d1,d8,d15 (capped at 2mg/dose) Etoposide 125mg/m^2 iv d1-5 Prednisolone 60mg/m^2 po d1-15 Adriamycin 40mg/m^2 iv d1 and 15

    Interventions:
    • Drug: doxorubicin hydrochloride
    • Drug: etoposide
    • Drug: prednisolone
    • Drug: vincristine sulfate
    • Radiation: radiation therapy
  • Experimental: Treatment Group 2: stages 2AE, 2B, 3A: OEPA x 2 + COPP x 2

    OEPA (28 day cycle) Vincristine 1.5mg/m^2 iv d1,d8,d15 (capped at 2mg/dose) Etoposide 125mg/m^2 iv d1-5 Prednisolone 60mg/m^2 po d1-15 Adriamycin 40mg/m^2 iv d1 and 15

    COPP (28 day cycle) Cyclophosphamide 500mg/m^2 iv d1 and 8 Vincristine 1.5mg/m^2 iv d1,8 (capped 2mg/dose) Procarbazine 100mg/m^2 po d1-15* Prednisolone 40mg/m^2 po d1-15

    Interventions:
    • Drug: cyclophosphamide
    • Drug: doxorubicin hydrochloride
    • Drug: etoposide
    • Drug: prednisolone
    • Drug: procarbazine hydrochloride
    • Drug: vincristine sulfate
    • Radiation: radiation therapy
  • Experimental: Treatment Group 3: stages 2BE, 3AE, 3B, 4: OEPAx2 + COPPx4

    OEPA (28 day cycle) Vincristine 1.5mg/m^2 iv d1,d8,d15 (capped at 2mg/dose) Etoposide 125mg/m^2 iv d1-5 Prednisolone 60mg/m^2 po d1-15 Adriamycin 40mg/m^2 iv d1 and 15

    COPP (28 day cycle) Cyclophosphamide 500mg/m^2 iv d1 and 8 Vincristine 1.5mg/m^2 iv d1,8 (capped 2mg/dose) Procarbazine 100mg/m^2 po d1-15* Prednisolone 40mg/m^2 po d1-15

    Interventions:
    • Drug: cyclophosphamide
    • Drug: doxorubicin hydrochloride
    • Drug: etoposide
    • Drug: prednisolone
    • Drug: procarbazine hydrochloride
    • Drug: vincristine sulfate
    • Radiation: radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 30 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00666484
CDR0000593560, UCL/07/005, 2007-003080-45, EU-20844
Yes
University College, London
University College, London
Not Provided
Principal Investigator: Kirit Ardeshna University College London Hospitals
University College, London
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP