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Sponsored by: |
Southampton General Hospital |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00637832 |
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving rituximab together with combination chemotherapy and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy and yttrium Y 90 ibritumomab tiuxetan works in treating patients with relapsed follicular non-Hodgkin lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisolone Drug: vincristine sulfate Radiation: yttrium Y 90 ibritumomab tiuxetan |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Short Chemo Radiotherapy in Follicular Lymphoma Trial of 90Y Ibritumomab Tiuxetan (ZevalinTM) as Therapy for First and Second Relapse in Follicular Lymphoma |
Estimated Enrollment: | 100 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed grade 1, 2, or 3 follicular non-Hodgkin lymphoma
In first or second relapse after prior treatment with a rituximab-containing chemotherapy regimen (R-chemo) or chemotherapy alone
Relapse must have occurred ≥ 6 months after completion of R-chemo
Has at least one of the following symptoms requiring initiation of treatment:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United Kingdom | |
Saint Bartholomew's Hospital | Recruiting |
London, United Kingdom, EC1A 7BE | |
Contact: Contact Person 44-207-377-7000 | |
United Kingdom, England | |
Christie Hospital | Recruiting |
Manchester, England, United Kingdom, M20 4BX | |
Contact: Contact Person 44-845-226-3000 | |
Mount Vernon Cancer Centre at Mount Vernon Hospital | Recruiting |
Northwood, England, United Kingdom, HA6 2RN | |
Contact: Contact Person 44-182-382-6111 | |
Poole Hospital NHS Trust | Recruiting |
Poole Dorset, England, United Kingdom, BH15 2JB | |
Contact: Contact Person 44-120-266-5511 | |
Southampton General Hospital | Recruiting |
Southampton, England, United Kingdom, SO16 6YD | |
Contact: Contact Person 44-238-079-8934 kc8@soton.ac.uk |
Principal Investigator: | Tim Illidge | Christie Hospital NHS Foundation Trust |
Study ID Numbers: | CDR0000588042, USCTU-SCHRIFT-06-DOG05-44, USCTU-SCHRIFT, USCTU-RHM-CAN0542, EUDRACT 2007-000222-51, EU-20819 |
Study First Received: | March 14, 2008 |
Last Updated: | February 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00637832 History of Changes |
Health Authority: | Unspecified |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma contiguous stage II grade 1 follicular lymphoma contiguous stage II grade 2 follicular lymphoma contiguous stage II grade 3 follicular lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma |
noncontiguous stage II grade 3 follicular lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma |
Anti-Inflammatory Agents Immunologic Factors Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Lymphoma, Follicular Prednisolone acetate Cyclophosphamide Hormones Follicular Lymphoma Lymphoma, Small Cleaved-cell, Diffuse Antibodies, Monoclonal Anti-Bacterial Agents Alkylating Agents Lymphoma |
Methylprednisolone Hemisuccinate Immunoglobulins Immunoproliferative Disorders Antineoplastic Agents, Hormonal Rituximab Methylprednisolone acetate Vincristine Antimitotic Agents Glucocorticoids Immunosuppressive Agents Doxorubicin Recurrence Lymphatic Diseases Antibodies Tubulin Modulators |
Anti-Inflammatory Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Lymphoma, Follicular Cyclophosphamide Antibiotics, Antineoplastic Hormones Antibodies, Monoclonal Therapeutic Uses Lymphoma Alkylating Agents Immunoproliferative Disorders |
Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Rituximab Mitosis Modulators Vincristine Antimitotic Agents Glucocorticoids Immunosuppressive Agents Doxorubicin Pharmacologic Actions Lymphatic Diseases Neoplasms Tubulin Modulators Prednisolone |