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| Sponsor: | Lymphoma Trials Office |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00032149 |
Purpose
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 |
Biological: bleomycin sulfate Biological: filgrastim Drug: cyclophosphamide Drug: etoposide 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.
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000069261, BNLI-GOODRISKHIV, EU-20144 |
| Study First Received: | March 8, 2002 |
| Last Updated: | April 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00032149 History of Changes |
| 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 |
|
Anti-Inflammatory Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Cyclophosphamide Antibiotics, Antineoplastic Hormones Sensory System Agents Therapeutic Uses Analgesics Etoposide Lymphoma Alkylating Agents |
Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Mitosis Modulators Vincristine Antimitotic Agents Glucocorticoids Bleomycin Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Tubulin Modulators Prednisolone |