Combination Chemotherapy Plus Filgrastim in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT00032149|
Recruitment Status : Unknown
Verified March 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 20, 2013
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 or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: bleomycin sulfate Biological: filgrastim Drug: cyclophosphamide Drug: etoposide Drug: mitoxantrone hydrochloride Drug: prednisolone Drug: vincristine sulfate||Phase 1 Phase 2|
- Determine the toxicity of mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, prednisolone, and filgrastim (G-CSF) in patients with good-prognosis (defined by the study as having 1 adverse prognostic factor) HIV-related non-Hodgkin's lymphoma.
- Determine the effects of this regimen on response rate, time to disease progression, and survival in these patients.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Official Title:||Pilot Study Of PMitCEBO Plus G-CSF In Good-Prognosis HIV-Related Lymphoma|
|Study Start Date :||October 2001|
- Effects of treatment on response rate, time to disease progression, and survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00032149
|Cheltenham General Hospital|
|Cheltenham, England, United Kingdom, GL53 7AN|
|St. Georges, University of London|
|London, England, United Kingdom, SW17 ORE|
|King's College Hospital|
|London, England, United Kingdom, W1T 4TJ|
|Edinburgh Cancer Centre at Western General Hospital|
|Edinburgh, Scotland, United Kingdom, EH4 2XU|
|Study Chair:||Ruth Pettengell, MD||St George's, University of London|