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
  Purpose

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.


Condition Intervention Phase
Lymphoma
Neurotoxicity
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: prednisolone
Drug: procarbazine hydrochloride
Drug: vincristine sulfate
Radiation: radiation therapy
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Neurotoxicity due to the intensive use of Vinca alkaloids [ Time Frame: End of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 47
Study Start Date: March 2008
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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

Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisolone Drug: procarbazine hydrochloride Drug: vincristine sulfate Radiation: radiation therapy

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

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666484

Locations
United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
King's College Hospital
London, England, United Kingdom, SE5 9RS
University College Hospital - London
London, England, United Kingdom, NW1 2PG
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN
Sponsors and Collaborators
University College, London
Investigators
Principal Investigator: Kirit Ardeshna University College London Hospitals
  More Information

No publications provided

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT00666484     History of Changes
Other Study ID Numbers: CDR0000593560, UCL/07/005, 2007-003080-45, EU-20844
Study First Received: April 24, 2008
Last Updated: December 3, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University College, London:
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

Additional relevant MeSH terms:
Neurotoxicity Syndromes
Hodgkin Disease
Lymphoma
Chemically-Induced Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Nervous System Diseases
Poisoning
Cyclophosphamide
Doxorubicin
Etoposide
Liposomal doxorubicin
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Procarbazine
Vincristine
Alkylating Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antiemetics
Antimitotic Agents

ClinicalTrials.gov processed this record on August 31, 2015