Filgrastim |
G-CSF; Neupogen |
Clinical Trial: Peripheral Stem Cell Transplantation Plus Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma
This study is no longer recruiting patients.
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus combination chemotherapy and rituximab in treating patients with non-Hodgkin's lymphoma.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Lymphoma | Drug: carmustine Drug: cisplatin Drug: cyclophosphamide Drug: dexamethasone Drug: etoposide Drug: filgrastim Drug: gemcitabine Drug: melphalan Drug: paclitaxel Drug: rituximab Drug: sargramostim | Phase II |
MedlinePlus related topics: Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Autologous Stem Cell Transplantation Using High Dose Carmustine and Melphalan Plus Gemcitabine Followed by Rituximab and Consolidation Chemotherapy in Patients with Poor Prognosis, Relapsed, or Refractory Intermediate and High Grade B-Cell Non-Hodgkin's Lymphoma
Study start: September 1998
OBJECTIVES: I. Evaluate the 1 and 2 year event free survival of patients with poor prognosis, relapsed or refractory intermediate or high grade B-cell non-Hodgkin's lymphoma who receive high dose carmustine and melphalan plus gemcitabine followed by rituximab (IDEC-C2B8 monoclonal antibody; anti-CD20 monoclonal antibody) plus sargramostim and consolidation chemotherapy with alternating dexamethasone/cyclophosphamide/ etoposide/cisplatin plus gemcitabine and paclitaxel/cisplatin and compare these figures to a historical control population. II. Evaluate the ability of posttransplant rituximab therapy in combination with sargramostim (GM-CSF) to control and further treat residual lymphoma remaining after high dose therapy in these patients. III. Evaluate quality of life parameters and assess the risk of secondary malignancies following this treatment regimen in these patients.
PROTOCOL OUTLINE: Patients receive high dose gemcitabine IV over 100 minutes on day -5 and again approximately 6 hours after carmustine IV over 2 hours on day -2. On day -1, patients receive melphalan IV over 20 minutes followed 24 hours later (day 0) with peripheral blood stem cells transplantation. Patients then receive sargramostim (GM-CSF) subcutaneously beginning on day 4 until granulocyte count is greater than 1,000/mm3 for 2 consecutive days. At weeks 5-8 posttransplant, patients receive rituximab (IDEC-C2B8 monoclonal antibody; anti-CD20 monoclonal antibody) IV over 3-4 hours weekly. Prior to rituximab treatment at week 4 posttransplant, patients receive sargramostim (GM-CSF) subcutaneously 3 times a week continuing through rituximab therapy. At approximately 3 and 9 months posttransplant, patients receive dexamethasone orally every day for days 1-4, and cyclophosphamide, etoposide, and cisplatin by continuous infusion for 4 days (days 1-4), and gemcitabine IV over 100 minutes on days 1 and 5. At approximately 6 and 12 months posttransplant, patients receive paclitaxel IV over 6 hours on day 2 and cisplatin IV over 24 hours on day 3. Patients are followed at least every 6 weeks to 3 months until death.
PROJECTED ACCRUAL: An estimated 25 patients per year will be accrued into this study.
Eligibility
Ages Eligible for Study: 18 Years - 75 Years
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Histologically confirmed intermediate or high grade B-cell non-Hodgkin's lymphoma that meets one of the following criteria: Relapsed or progressed following at least 1 course of standard therapy; Developed from a low grade lymphoma regardless of remission status; In first complete response with 3 or more of the following pretreatment criteria met at the time of original diagnosis: Stage III/IV disease; Two or more extranodal sites of disease; Lactate dehydrogenase greater than 1.2 times normal; Performance status 2-4 (at time of diagnosis); Dimension of the largest tumor at least 10 cm
- No myelodysplasia
[A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.]
--Prior/Concurrent Therapy--
- See Disease Characteristics
--Patient Characteristics--
- Age: 18 to 75
- Performance status: See Disease Characteristics; ECOG 0-2 (ECOG 3-4 acceptable if based solely on pain)
- Life expectancy: Not specified
- Hematopoietic: CD34 cells at least 1,000/g
- Hepatic: See Disease Characteristics Bilirubin no greater than 1.5 mg/dL; Transaminases no greater than 4 times upper limit of normal; No active chronic hepatitis or liver cirrhosis
- Renal: Creatinine no greater than 3.0 mg/dL
- Cardiovascular: No evidence for clinically significant functional impairment; Left ventricular ejection fraction at least 45%; Patients with lower ejection fractions may be included if a formal cardiological evaluation reveals no evidence for clinically significant functional impairment
- Pulmonary: FEV1, FVC, and DLCO at least 50% of predicted; If unable to complete pulmonary function tests due to bone pain or fracture, must have a high resolution CT scan of the chest and acceptable blood arterial gases defined as PO2 greater than 70
- Other: HIV negative; No active infection that is unresponsive to intravenous antibiotics; Not pregnant or nursing; Effective contraception required of all fertile patients
Location Information
Maryland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, 21201, United States
Aaron P. Rapoport, Study Chair, University of Maryland Greenebaum Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: April 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003397
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Filgrastim (Drug Digest)
- G-CSF (Drug Digest)

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