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Sponsored by: |
Lymphoma Trials Office |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00032149 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase I/II trial to study the effectiveness of combining filgrastim with combination chemotherapy in treating patients who have HIV-related non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: bleomycin Drug: cyclophosphamide Drug: etoposide Drug: filgrastim Drug: mitoxantrone hydrochloride Drug: prednisolone Drug: vincristine sulfate |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Pilot Study Of PMitCEBO Plus G-CSF In Good-Prognosis HIV-Related Lymphoma |
Estimated Enrollment: | 30 |
Study Start Date: | October 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive mitoxantrone IV, cyclophosphamide IV, and etoposide IV on day 1; and vincristine IV and bleomycin IV on day 8. Patients also receive prednisolone daily on weeks 1-4 and then every other day on weeks 5-16. Patients receive filgrastim (G-CSF) subcutaneously on days 6-12. Treatment repeats every 2 weeks for up to 8 courses (16 weeks) in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) or partial response (PR) receive 4 courses beyond CR or PR.
Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed previously untreated HIV-related non-Hodgkin's lymphoma with 1 of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic:
Chemotherapy:
Endocrine:
Radiotherapy:
Surgery:
United Kingdom, England | |
Cheltenham General Hospital | |
Cheltenham, England, United Kingdom, GL53 7AN | |
King's College Hospital | |
London, England, United Kingdom, W1T 4TJ | |
St. Georges, University of London | |
London, England, United Kingdom, SW17 ORE | |
United Kingdom, Scotland | |
Edinburgh Cancer Centre at Western General Hospital | |
Edinburgh, Scotland, United Kingdom, EH4 2XU |
Study Chair: | Ruth Pettengell, MD | St George's, University of London |
Study ID Numbers: | CDR0000069261, BNLI-GOODRISKHIV, EU-20144 |
Study First Received: | March 8, 2002 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00032149 |
Health Authority: | United States: Federal Government |
AIDS-related peripheral/systemic lymphoma AIDS-related primary CNS lymphoma AIDS-related diffuse large cell lymphoma AIDS-related immunoblastic large cell lymphoma |
AIDS-related small noncleaved cell lymphoma AIDS-related diffuse mixed cell lymphoma AIDS-related diffuse small cleaved cell lymphoma AIDS-related lymphoblastic lymphoma |
Methylprednisolone Lymphoma, small cleaved-cell, diffuse Prednisolone acetate Cyclophosphamide Small non-cleaved cell lymphoma Etoposide phosphate Lymphoma, large-cell, immunoblastic Central nervous system lymphoma, primary Lymphoma, large-cell Lymphoma, AIDS-Related Lymphoma, Large-Cell, Immunoblastic Lymphoma Etoposide Methylprednisolone Hemisuccinate |
Lymphoma, AIDS-related Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Acquired Immunodeficiency Syndrome Methylprednisolone acetate Vincristine Lymphoblastic lymphoma Bleomycin Lymphatic Diseases HIV Infections Prednisolone Mitoxantrone Lymphoproliferative Disorders Lymphoma, Non-Hodgkin |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Sensory System Agents Therapeutic Uses Analgesics Alkylating Agents Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents, Hormonal |
Mitosis Modulators Antimitotic Agents Immunosuppressive Agents Glucocorticoids Pharmacologic Actions Neoplasms Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Peripheral Nervous System Agents Antirheumatic Agents Antineoplastic Agents, Phytogenic Central Nervous System Agents |