A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years
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| ClinicalTrials.gov Identifier: NCT00079105 |
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Recruitment Status :
Completed
First Posted : March 9, 2004
Last Update Posted : March 30, 2017
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma | Biological: bleomycin sulfate Drug: cyclophosphamide Drug: etoposide Drug: mitoxantrone hydrochloride Drug: prednisolone Drug: procarbazine hydrochloride Drug: vinblastine sulfate | Phase 2 |
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 (Clinical Trial) |
| Actual Enrollment : | 175 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | January 2004 |
| Actual Primary Completion Date : | December 2010 |
| Actual Study Completion Date : | December 2010 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Treatment
Treatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate
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Biological: bleomycin sulfate
Treatment
Other Name: Blenoxane Drug: cyclophosphamide Treatment
Other Name: Cytoxan Drug: etoposide Treatment
Other Names:
Drug: mitoxantrone hydrochloride Treatment
Other Name: Novantrone Drug: prednisolone Treatment
Other Names:
Drug: procarbazine hydrochloride Treatment
Other Name: Matulane Drug: vinblastine sulfate Treatment
Other Name: Vincristine |
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No Intervention: Registration
Registration, without treatment
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- Disease-free survival by routine imaging [ Time Frame: 6 month intervals ]
- Overall survival by routine imaging [ Time Frame: 5 years ]
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| Ages Eligible for Study: | 60 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00079105
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| 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 |
| Responsible Party: | Newcastle-upon-Tyne Hospitals NHS Trust |
| ClinicalTrials.gov Identifier: | NCT00079105 |
| Other Study ID Numbers: |
CDR0000354225 UON-SHIELD ( Other Identifier: Sponsor ) EU-20346 ( Other Identifier: Sponsor ) |
| First Posted: | March 9, 2004 Key Record Dates |
| Last Update Posted: | March 30, 2017 |
| Last Verified: | March 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | No IPD were shared, nor will be, for this trial. |
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stage I adult Hodgkin lymphoma stage II adult Hodgkin lymphoma stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma |
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Lymphoma Hodgkin Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Prednisolone Cyclophosphamide Etoposide Vincristine Mitoxantrone Bleomycin Vinblastine |
Procarbazine Prednisolone phosphate Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |