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Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Disease
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: April 18, 2009   History of Changes
Sponsored by: Medical Research Council
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003421
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for advanced Hodgkin's disease.

PURPOSE: Randomized phase III trial to compare different combination chemotherapy regimens in treating patients with advanced Hodgkin's disease.


Condition Intervention Phase
Lymphoma
Biological: bleomycin sulfate
Drug: ABVD regimen
Drug: chlorambucil
Drug: dacarbazine
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: prednisolone
Drug: procarbazine hydrochloride
Drug: vinblastine
Drug: vincristine sulfate
Radiation: radiation therapy
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: A UKLG Randomised Trial of Initial Chemotherapy for Advanced Stage Hodgkins Disease

Resource links provided by NLM:


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

Estimated Enrollment: 800
Study Start Date: June 1998
Detailed Description:

OBJECTIVES: I. Determine whether a four-drug anthracycline-based regimen or a seven-drug hybrid or eight-drug alternating regimen is the optimal treatment for patients with advanced Hodgkin's disease.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I (ABVD): Patients receive doxorubicin IV, bleomycin IV, vinblastine IV, and dacarbazine IV on days 1 and 15. Courses repeat every 4 weeks. Arm II (ChlVPP/PABLOE): Patients receive oral chlorambucil, procarbazine, and prednisolone on days 1-14; vinblastine IV on days 1 and 8; doxorubicin IV on day 29; vincristine IV and bleomycin IV on days 29 and 36; oral etoposide on days 29-31; and oral prednisolone again on days 29-38. Courses repeat every 7 weeks. OR (Hybrid - ChlVPP/EVA): Patients receive vincristine IV on day 1; oral etoposide on days 1-5; oral chlorambucil, procarbazine, and prednisolone on days 1-7; and doxorubicin IV and vinblastine IV on day 8. Courses repeat every 4 weeks. Patients in both arms receive up to 6-8 courses of treatment. Radiotherapy may be given to sites of previous bulk disease for patients in complete remission or uncertain remission. Patients who achieve partial remission may receive radiotherapy to residual disease sites. Patients who fail to respond, or have disease progression, may receive induction therapy followed by high-dose consolidation therapy. Patients are followed every 3 months for 2 years, every 6 months for 5 years, and then annually for 5 years.

PROJECTED ACCRUAL: Approximately 800 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed advanced Hodgkin's disease requiring systemic therapy Stage IA or IIA disease with bulky disease or more than three sites of involvement are also eligible

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other active malignancy within 5 years HIV negative Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for Hodgkin's disease Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for Hodgkin's disease Surgery: Not specified

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003421

Locations
United Kingdom, England
St. James's Hospital
Leeds, England, United Kingdom, LS9 7TF
Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
Sponsors and Collaborators
Medical Research Council
Investigators
Study Chair: Barry W. Hancock, MD Cancer Research Centre at Weston Park Hospital
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000066441, MRC-UKLG-LY09, EU-98020
Study First Received: November 1, 1999
Last Updated: April 18, 2009
ClinicalTrials.gov Identifier: NCT00003421     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma

Study placed in the following topic categories:
Anti-Inflammatory Agents
Dacarbazine
Methylprednisolone
Hormone Antagonists
Chlorambucil
Hormones, Hormone Substitutes, and Hormone Antagonists
Vinblastine
Prednisolone acetate
Hormones
Etoposide phosphate
Anti-Bacterial Agents
Hodgkin Disease
Lymphoma
Etoposide
Alkylating Agents
Methylprednisolone Hemisuccinate
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Hodgkin Lymphoma, Adult
Vincristine
Methylprednisolone acetate
Hodgkin's Disease
Antimitotic Agents
Glucocorticoids
Bleomycin
Doxorubicin
Lymphatic Diseases
Tubulin Modulators
Prednisolone
Procarbazine

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Dacarbazine
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Chlorambucil
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Vinblastine
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
Bleomycin
Glucocorticoids
Doxorubicin
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Tubulin Modulators
Prednisolone
Procarbazine

ClinicalTrials.gov processed this record on September 02, 2009