Combination Chemotherapy in Treating Younger Patients With Hodgkin Lymphoma - Full Text View

Sponsored by:	Cancer Research UK
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00666484

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
Cancer-Related Problem/Condition Lymphoma	Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisolone Drug: procarbazine hydrochloride Drug: vincristine sulfate Radiation: radiation therapy	Phase II

MedlinePlus related topics: Cancer Hodgkin's Disease Lymphoma Radiation Therapy

Drug Information available for: Cyclophosphamide Prednisolone Prednisolone acetate Depo-medrol Vincristine Doxorubicin Doxorubicin hydrochloride Etoposide Medrol veriderm Methylprednisolone Myocet Prednisolone sodium phosphate Procarbazine hydrochloride Procarbazine Prednisolone Sodium Succinate Vincristine sulfate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Neurotoxicity due to the intensive use of Vinca alkaloids [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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

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

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

Locations

United Kingdom, England
King's College Hospital	Recruiting
London, England, United Kingdom, SE5 9RS
Contact: Contact Person 44-20-3299-9000
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
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
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
University College Hospital - London	Recruiting
London, England, United Kingdom, NW1 2PG
Contact: Kirit Ardeshna 44-20-7380-6962 kirit.ardeshna@uclh.nhs.uk

Sponsors and Collaborators

Cancer Research UK

Investigators

Principal Investigator:

Kirit Ardeshna

University College London Hospitals

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000593560, CRUK-BRD/07/005, EUDRACT-2007-003080-45
Study First Received:	April 24, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00666484 History of Changes
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

Study placed in the following topic categories:

Anti-Inflammatory Agents
Neurotoxicity Syndromes
Immunologic Factors
Hodgkin Lymphoma, Childhood
Methylprednisolone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Prednisolone acetate
Cyclophosphamide
Hormones
Etoposide phosphate
Anti-Bacterial Agents
Alkylating Agents
Hodgkin Disease
Lymphoma

Etoposide
Methylprednisolone Hemisuccinate
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Hodgkin Lymphoma, Adult
Methylprednisolone acetate
Hodgkin's Disease
Vincristine
Sclerosis
Antimitotic Agents
Glucocorticoids
Immunosuppressive Agents
Doxorubicin
Lymphatic Diseases
Tubulin Modulators

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cyclophosphamide
Antibiotics, Antineoplastic
Hormones
Therapeutic Uses
Lymphoma
Hodgkin Disease
Alkylating Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type

Antineoplastic Agents, Hormonal
Immune System Diseases
Mitosis Modulators
Vincristine
Antimitotic Agents
Glucocorticoids
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Tubulin Modulators
Prednisolone
Myeloablative Agonists
Procarbazine

ClinicalTrials.gov processed this record on May 07, 2009