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| Sponsor: | Lymphoma Trials Office |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00031902 |
Purpose
RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab with chemotherapy may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of rituximab plus combination chemotherapy in treating patients who have HIV-related non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: bleomycin sulfate Biological: rituximab Drug: prednisolone Drug: vincristine sulfate |
Phase I |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Rituxumab Combined With Chemotherapy (PVB) For Poor Prognosis HIV-Related Non-Hodgkin's Lymphoma |
| Study Start Date: | October 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive chemotherapy comprising vincristine IV and bleomycin IV on day 1 and oral prednisolone every other day beginning on day 1. Treatment repeats every 3 weeks for 6 courses. Patients also receive rituximab on days 14, 21, 28, and 35. Patients who achieve complete response (CR) receive 2 additional courses of chemotherapy after CR.
Patients are followed every 1-2 months.
PROJECTED ACCRUAL: A total of 10-20 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:
Diagnosis of poor-prognosis, HIV-related non-Hodgkin's lymphoma (HIV-NHL)
More than 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United Kingdom | |
| St. George's Hospital | |
| London, England, United Kingdom, SW17 0QT | |
| Chelsea Westminster Hospital | |
| London, United Kingdom, SW10 9NH | |
| Study Chair: | Ruth Pettengell, MD | St. George's Hospital |
More Information
| ClinicalTrials.gov Identifier: | NCT00031902 History of Changes |
| Other Study ID Numbers: | CDR0000069238, BNLI-POORRISKHIV, EU-20145 |
| Study First Received: | March 8, 2002 |
| Last Updated: | April 18, 2009 |
| Health Authority: | United States: Federal Government |
|
AIDS-related peripheral/systemic 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 |
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bleomycin Rituximab Prednisolone Methylprednisolone Hemisuccinate Vincristine Methylprednisolone acetate Prednisolone acetate |
Methylprednisolone Prednisolone phosphate Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antiemetics Autonomic Agents Peripheral Nervous System Agents |
