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

• ClinicalTrials.gov Identifier: NCT00079105
• Recruitment Status: Completed
• First Posted: March 9, 2004
• Last Update Posted: March 30, 2017
• Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
• Information provided by (Responsible Party): Newcastle-upon-Tyne Hospitals NHS Trust

Tracking Information

• First Submitted Date: March 8, 2004
• First Posted Date: March 9, 2004
• Last Update Posted Date: March 30, 2017
• Study Start Date: January 2004
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 7, 2015): Disease-free survival by routine imaging [ Time Frame: 6 month intervals ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures (submitted: October 7, 2015): Overall survival by routine imaging [ Time Frame: 5 years ]
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

Brief Summary

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.

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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Lymphoma

Intervention

• 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

Study Arms

• Active Comparator: Treatment
  Treatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate
  Interventions:

  • Biological: bleomycin sulfate
  • Drug: cyclophosphamide
  • Drug: etoposide
  • Drug: mitoxantrone hydrochloride
  • Drug: prednisolone
  • Drug: procarbazine hydrochloride
  • Drug: vinblastine sulfate
• No Intervention: Registration
  Registration, without treatment

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 7, 2015): 175
• Original Enrollment: Not Provided
• Actual Study Completion Date: December 2010
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years to 120 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany, United Kingdom

Administrative Information

• NCT Number: NCT00079105
• Other Study ID Numbers: CDR0000354225; UON-SHIELD ( Other Identifier: Sponsor ); EU-20346 ( Other Identifier: Sponsor )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: No IPD were shared, nor will be, for this trial.

• Current Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
• Original Responsible Party: Not Provided
• Current Study Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
• Original Study Sponsor: University of Newcastle Upon-Tyne
• Collaborators: Not Provided

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

• PRS Account: Newcastle-upon-Tyne Hospitals NHS Trust
• Verification Date: March 2017