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: October 7, 2015
Last verified: October 2015
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival by routine imaging [ Time Frame: 5 years ] [ Designated as safety issue: No ]

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, Cyclophosphamide, Procarbazine, Prednisolone, Etoposide, Mitoxantrone, and Bleomycin.
Biological: bleomycin sulfate Drug: cyclophosphamide Drug: etoposide Drug: mitoxantrone hydrochloride Drug: prednisolone Drug: procarbazine hydrochloride Drug: vinblastine sulfate
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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed classical Hodgkin's lymphoma

    • Previously untreated disease
  • No nodular lymphocyte predominant Hodgkin's lymphoma

PATIENT CHARACTERISTICS:

Age

  • Over 60

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • No significant hepatic abnormality that would preclude study participation

Renal

  • No significant renal abnormality that would preclude study participation

Cardiovascular

  • No significant cardiac abnormality that would preclude study participation

Pulmonary

  • No significant pulmonary abnormality that would preclude study participation

Other

  • "Non-fragile" status (i.e., mental and physical status must be sufficient to withstand study therapy)
  • HIV negative
  • No other concurrent neoplasia

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  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, FRCP, FRCPath 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

No publications provided

Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT00079105     History of Changes
Other Study ID Numbers: CDR0000354225  UON-SHIELD  EU-20346 
Study First Received: March 8, 2004
Last Updated: October 7, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee
United Kingdom: Department of Health
Scotland: Scottish Executive Health Department

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:
Hodgkin Disease
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Bleomycin
Cyclophosphamide
Etoposide
Etoposide phosphate
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Mitoxantrone
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Procarbazine
Vinblastine
Alkylating Agents
Analgesics
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antiemetics
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on February 11, 2016