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A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00079105
First received: March 8, 2004
Last updated: March 29, 2017
Last verified: March 2017
  Purpose

RATIONALE: Drugs used in chemotherapy, such as vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating older patients with previously untreated Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma Biological: bleomycin sulfate Drug: cyclophosphamide Drug: etoposide Drug: mitoxantrone hydrochloride Drug: prednisolone Drug: procarbazine hydrochloride Drug: vinblastine sulfate Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years; Vinblastine, Cyclophosphamide, Procarbazine, Prednisolone, Etoposide, Mitoxantrone, and Bleomycin in Treating Older Patients With Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Newcastle-upon-Tyne Hospitals NHS Trust:

Primary Outcome Measures:
  • Disease-free survival by routine imaging [ Time Frame: 6 month intervals ]

Secondary Outcome Measures:
  • Overall survival by routine imaging [ Time Frame: 5 years ]

Enrollment: 175
Study Start Date: January 2004
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment
Treatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate
Biological: bleomycin sulfate
Treatment
Other Name: Blenoxane
Drug: cyclophosphamide
Treatment
Other Name: Cytoxan
Drug: etoposide
Treatment
Other Names:
  • Eposin
  • Etopophos
  • Vepesid
Drug: mitoxantrone hydrochloride
Treatment
Other Name: Novantrone
Drug: prednisolone
Treatment
Other Names:
  • Flo-Pred
  • Pediapred
  • Orapred
Drug: procarbazine hydrochloride
Treatment
Other Name: Matulane
Drug: vinblastine sulfate
Treatment
Other Name: Vincristine
No Intervention: Registration
Registration, without treatment

Detailed Description:

OBJECTIVES:

Primary

  • Determine the efficacy and toxicity of vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin in older patients with Hodgkin's lymphoma.
  • Determine whether the application of the Hasenclever prognostic index is valid in these patients at diagnosis.

OUTLINE: This is an open-label, multicenter study.

  • Chemotherapy: Patients receive vinblastine IV and cyclophosphamide IV on day 1; oral procarbazine and oral prednisolone on days 1-5; oral etoposide on days 15-19; and mitoxantrone IV and bleomycin IV on day 15. Treatment repeats every 28 days, in the absence of disease progression or unacceptable toxicity, for a total of 3 courses in patients with early (stage IA or IIA) disease or 6 courses in patients with advanced (stage IB or IIB-IV) disease.
  • Radiotherapy: Patients with early stage disease receive involved-field radiotherapy. Patients with advanced stage disease receive radiotherapy limited to sites of initial bulky disease or residual disease. Radiotherapy begins 4 weeks after the completion of chemotherapy.

Patients are followed monthly for 3 months, every 3 months for 6 months, and then annually thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 36 months.

  Eligibility

Ages Eligible for Study:   60 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Histologically confirmed classical Hodgkin Lymphoma (HL). No previous treatment for HL. Age ≥ 60. "Non fragile" patient (see Appendix 1) i.e. patient's mental and physical status must be sufficient to withstand the treatment described.

No concomitant neoplasia requiring treatment or known HIV infection. Written informed consent.

Exclusion criteria:

Nodular lymphocyte predominance Hodgkin Lymphoma (NLPHL) Age <60. Patient previously treated for HL. Known HIV infection or concomitant neoplasia. "Fragile patient" (see Appendix 1) or significant abnormality of another system (pulmonary, cardiac, renal, and hepatic) which is a contraindication to full dose chemotherapy.

Unable to give informed consent.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079105

  Show 54 Study Locations
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
Investigators
Study Chair: Stephen J. Proctor, MD University of Newcastle Upon-Tyne
Study Director: Helen H. Lucraft, MD Northern Centre for Cancer Treatment at Newcastle General Hospital
Study Director: Katrina M. Wood, MD Sir James Spence Institute of Child Health at Royal Victoria Infirmary
  More Information

Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT00079105     History of Changes
Other Study ID Numbers: CDR0000354225
UON-SHIELD ( Other Identifier: Sponsor )
EU-20346 ( Other Identifier: Sponsor )
Study First Received: March 8, 2004
Last Updated: March 29, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: No IPD were shared, nor will be, for this trial.

Keywords provided by Newcastle-upon-Tyne Hospitals NHS Trust:
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Etoposide phosphate
Etoposide
Procarbazine
Bleomycin
Vinblastine
Mitoxantrone
Prednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 22, 2017