Vinblastine, Cyclophosphamide, Procarbazine, Prednisolone, Etoposide, Mitoxantrone, and Bleomycin in Treating Older Patients With Hodgkin's Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00079105
First received: March 8, 2004
Last updated: November 2, 2010
Last verified: June 2009
  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: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Disease-free survival by routine imaging at 6 month intervals [ Designated as safety issue: No ]

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

Estimated Enrollment: 150
Study Start Date: January 2004
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
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 and older
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
University of Newcastle Upon-Tyne
Investigators
Study Chair: Stephen J. Proctor, MD, FRCP, FRCPath University of Newcastle Upon-Tyne
Investigator: Helen H. Lucraft, MD Northern Centre for Cancer Treatment at Newcastle General Hospital
Investigator: Katrina M. Wood, MD Sir James Spence Institute of Child Health at Royal Victoria Infirmary
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00079105     History of Changes
Other Study ID Numbers: CDR0000354225, UON-SHIELD, EU-20346
Study First Received: March 8, 2004
Last Updated: November 2, 2010
Health Authority: Unspecified

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

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

ClinicalTrials.gov processed this record on August 21, 2014