Combination Chemotherapy in Treating Young Patients With Hodgkin's Lymphoma - Full Text View

Sponsored by:	Martin-Luther-Universität Halle-Wittenberg
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00433459

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. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to compare how well they work in treating young patients with Hodgkin's lymphoma.

Condition	Intervention	Phase
Lymphoma	Drug: bleomycin Drug: carmustine Drug: cyclophosphamide Drug: cytarabine Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: etoposide Drug: etoposide phosphate Drug: fludeoxyglucose F 18 Drug: ifosfamide Drug: melphalan Drug: prednisolone Drug: prednisone Drug: procarbazine hydrochloride Drug: vinblastine Drug: vincristine sulfate Procedure: autologous hematopoietic stem cell transplantation Procedure: positron emission tomography Procedure: radiation therapy	Phase III

MedlinePlus related topics: Cancer Hodgkin's Disease Lymphoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Ifosfamide Cyclophosphamide Cytarabine Cytarabine hydrochloride Etoposide Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Prednisone Vincristine sulfate Vincristine Carmustine Melphalan Dacarbazine Etoposide phosphate Melphalan hydrochloride Sarcolysin Procarbazine hydrochloride Procarbazine Vinblastine Vinblastine sulfate Fluorodeoxyglucose F18 Bleomycin Bleomycin sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control
Official Title:	First International Inter-Group Study for Classical Hodgkin's Lymphoma in Children and Adolescents

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

Primary Outcome Measures:

Event-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Designated as safety issue: No ]
Progression-free survival [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Evidence of male infertility score [ Designated as safety issue: No ]
Evidence of female sexual functioning score [ Designated as safety issue: No ]
Long-term consequences (e.g., premature menopause, secondary cancer) [ Designated as safety issue: No ]

Estimated Enrollment:	2150
Study Start Date:	January 2007

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed classical Hodgkin's lymphoma
- No lymphocyte-predominant Hodgkin's lymphoma
- Fine-needle biopsy not sufficient
No prior treatment for Hodgkin's lymphoma except for recommended pre-phase therapy for a large mediastinal tumor

PATIENT CHARACTERISTICS:

No known hypersensitivity or contraindication to study drugs
No other current malignancy
No severe concurrent disease (e.g., immune deficiency syndrome)
Not pregnant or nursing
Fertile patients must use effective contraception during and for up to 1 year after completion of study treatment
No known HIV positivity

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior chemotherapy or radiotherapy
At least 30 days since prior and no other concurrent investigational drugs or participation in another investigational trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00433459

Locations

Germany
Universitaetsklinikum Halle	Recruiting
Halle, Germany, D-06097
Contact: Dieter Koerholz, MD 49-345-557-2387
United Kingdom, Scotland
Royal Hospital for Sick Children	Recruiting
Edinburgh, Scotland, United Kingdom, EH9 1LF
Contact: W. Hamish Wallace, MD 44-131-536-0426

Sponsors and Collaborators

Martin-Luther-Universität Halle-Wittenberg

Investigators

Study Chair:	Dieter Koerholz, MD	Martin-Luther-Universität Halle-Wittenberg
Investigator:	W. Hamish Wallace, MD	Royal Hospital for Sick Children
Investigator:	Judith Landman-Parker, MD	Hopital d'Enfants Trousseau

More Information

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

Study ID Numbers:	CDR0000531687, EURONET-PHL-C1, EU-20703, EUDRACT-2006-000995-33, CCLG-HD-2007-10
Study First Received:	February 8, 2007
Last Updated:	August 23, 2008
ClinicalTrials.gov Identifier:	NCT00433459
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

childhood lymphocyte depletion Hodgkin lymphoma
childhood mixed cellularity Hodgkin lymphoma
childhood nodular sclerosis Hodgkin lymphoma
stage I childhood Hodgkin lymphoma

stage II childhood Hodgkin lymphoma
stage III childhood Hodgkin lymphoma
stage IV childhood Hodgkin lymphoma

Study placed in the following topic categories:

Prednisone
Melphalan
Hodgkin's disease
Dacarbazine
Methylprednisolone
Hodgkin lymphoma, adult
Prednisolone acetate
Vinblastine
Cyclophosphamide
Etoposide phosphate
Hodgkin Disease
Lymphoma
Etoposide
Cytarabine
Methylprednisolone Hemisuccinate

Immunoproliferative Disorders
Carmustine
Methylprednisolone acetate
Vincristine
Sclerosis
Bleomycin
Doxorubicin
Lymphatic Diseases
Ifosfamide
Hodgkin lymphoma, childhood
Prednisolone
Procarbazine
Lymphoproliferative Disorders
Isophosphamide mustard

Additional relevant MeSH terms:

Antimetabolites
Anti-Inflammatory Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antibiotics, Antineoplastic
Hormones
Therapeutic Uses
Alkylating Agents
Neoplasms by Histologic Type

Immune System Diseases
Antineoplastic Agents, Hormonal
Mitosis Modulators
Antimitotic Agents
Immunosuppressive Agents
Antiviral Agents
Glucocorticoids
Pharmacologic Actions
Neoplasms
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009