Combination Chemotherapy in Treating Younger Patients With Hodgkin Lymphoma | Completed
Combination Chemotherapy in Treating Younger Patients With Hodgkin Lymphoma

Trial Source

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Health Conditions
  • Lymphoma
  • Neurotoxicity
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT00666484
Primary Trial ID Number
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.
Research Details
  • 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.
Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : cyclophosphamide, Drug : doxorubicin hydrochloride, Drug : etoposide, Drug : prednisolone, Drug : procarbazine hydrochloride, Drug : vincristine sulfate, Radiation : radiation therapy

Study Arm Groups : Treatment Group 2: stages 2AE, 2B, 3A: OEPA x 2 + COPP x 2, Treatment Group 3: stages 2BE, 3AE, 3B, 4: OEPAx2 + COPPx4, Treatment Group 1: stages 1A, 1B, 2A: OEPA x 2, Treatment Group 2: stages 2AE, 2B, 3A: OEPA x 2 + COPP x 2, Treatment Group 3: stages 2BE, 3AE, 3B, 4: OEPAx2 + COPPx4, Treatment Group 1: stages 1A, 1B, 2A: OEPA x 2, Treatment Group 2: stages 2AE, 2B, 3A: OEPA x 2 + COPP x 2, Treatment Group 3: stages 2BE, 3AE, 3B, 4: OEPAx2 + COPPx4, Treatment Group 1: stages 1A, 1B, 2A: OEPA x 2, Treatment Group 2: stages 2AE, 2B, 3A: OEPA x 2 + COPP x 2, Treatment Group 3: stages 2BE, 3AE, 3B, 4: OEPAx2 + COPPx4, Treatment Group 2: stages 2AE, 2B, 3A: OEPA x 2 + COPP x 2, Treatment Group 3: stages 2BE, 3AE, 3B, 4: OEPAx2 + COPPx4, Treatment Group 1: stages 1A, 1B, 2A: OEPA x 2, Treatment Group 2: stages 2AE, 2B, 3A: OEPA x 2 + COPP x 2, Treatment Group 3: stages 2BE, 3AE, 3B, 4: OEPAx2 + COPPx4, Treatment Group 1: stages 1A, 1B, 2A: OEPA x 2, Treatment Group 2: stages 2AE, 2B, 3A: OEPA x 2 + COPP x 2, Treatment Group 3: stages 2BE, 3AE, 3B, 4: OEPAx2 + COPPx4

Intervention Type
See Interventions above
Primary Outcome Measures
  • Neurotoxicity due to the intensive use of Vinca alkaloids; End of treatment
Secondary Outcome Measures
  • Response rate; End of treatment; Disease-free survival; Not specified in protocol; Overall survival; Not specified in protocol; Gonadal toxicity; Not specified in protocol
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - 30 Years
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
St. James University Hospital
Leeds
LS9 7TF
King's College Hospital
London
England
SE5 9RS
London
NW1 2PG
Research Site
Northwood
Middlesex
HA6 2RN
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle-Upon-Tyne
England
NE4 6BE
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific 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
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CDR0000593560
Sponsor(s)
University College, London
Key Dates

Recruitment Start Date

Mar 2008

Recruitment End Date

Sep 2012

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

24 Apr 2008

Last Updated

03 Dec 2014