Combination Chemotherapy in Treating Younger Patients With Hodgkin Lymphoma
Recruitment status was Recruiting
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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 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 |
- Neurotoxicity due to the intensive use of Vinca alkaloids [ 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 ]
| Estimated Enrollment: | 45 |
| Study Start Date: | March 2008 |
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 |
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| United Kingdom | |
| Leeds Cancer Centre at St. James's University Hospital | Recruiting |
| Leeds, England, United Kingdom, LS9 7TF | |
| Contact: Contact Person 44-113-206-7851 a.s.jack@leeds.ac.uk | |
| King's College Hospital | Recruiting |
| London, England, United Kingdom, SE5 9RS | |
| Contact: Contact Person 44-20-3299-9000 | |
| University College Hospital - London | Recruiting |
| London, England, United Kingdom, NW1 2PG | |
| Contact: Kirit Ardeshna 44-20-7380-6962 kirit.ardeshna@uclh.nhs.uk | |
| Northern Centre for Cancer Treatment at Newcastle General Hospital | Recruiting |
| Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE | |
| Contact: Helen H. Lucraft, MD 44-191-256-3565 helen.lucraft@nuth.nhs.uk | |
| Mount Vernon Cancer Centre at Mount Vernon Hospital | Recruiting |
| Northwood, England, United Kingdom, HA6 2RN | |
| Contact: Kirit Ardeshna 44-1923-844-413 kirit.ardeshna@uclh.nhs.uk | |
| Principal Investigator: | Kirit Ardeshna | University College London Hospitals |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00666484 History of Changes |
| Other Study ID Numbers: | CDR0000593560, CRUK-BRD/07/005, EUDRACT-2007-003080-45, EU-20844 |
| Study First Received: | April 24, 2008 |
| Last Updated: | September 1, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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:
|
Hodgkin Disease Lymphoma Neurotoxicity Syndromes Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Nervous System Diseases Poisoning Substance-Related Disorders Cyclophosphamide Doxorubicin Etoposide |
Prednisolone Methylprednisolone Hemisuccinate Procarbazine Vincristine Methylprednisolone acetate Prednisolone acetate Methylprednisolone Prednisolone hemisuccinate Prednisolone phosphate Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013