Waldenström's Macroglobulinemia |
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Clinical Trial: Chemotherapy and Radiation Therapy Followed by Peripheral Stem Cell Transplantation 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. Radiation therapy uses high-energy x-rays to damage cancer cells. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and radiation therapy and kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of etoposide plus radiation therapy followed by peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| recurrent diffuse small lymphocytic/marginal zone lymphoma Waldenstrom's Macroglobulinemia recurrent grade III follicular large cell lymphoma recurrent grade I follicular small cleaved cell lymphoma recurrent small lymphocytic lymphoma recurrent grade II follicular mixed cell lymphoma | Drug: cyclophosphamide Drug: etoposide Drug: filgrastim Drug: mesna | Phase I Phase II |
MedlinePlus related topics: Blood and Blood Disorders; Immune System and Disorders; Lymphatic Diseases; Lymphoma; Vascular Diseases
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I/II Pilot Study of High-Dose VP-16 and Radiotherapy Followed by PBSC Rescue for Selected Poor-Prognosis non-Hodgkin's Lymphomas
Study start: April 1992
OBJECTIVES: I. Evaluate the overall and progression-free survival of patients with selected poor-prognosis non-Hodgkin's lymphomas treated with high-dose etoposide and total-body irradiation followed by rescue with peripheral blood stem cells.
II. Determine the toxicity of this regimen.
III. Evaluate the short-term and long-term engraftment characteristics of patients treated on this regimen.
PROTOCOL OUTLINE: Patients who respond on Regimen A and who have no bulk disease greater than 5 cm are treated on Regimen B.
Regimen A: Single-Agent Chemotherapy/Stem Cell Mobilization with Urothelial Protection and Growth Factor Therapy. Cyclophosphamide, CTX, NSC-26271; with Mesna, NSC-113891; and Granulocyte Colony Stimulating Factor (Amgen), G-CSF, NSC-614629.
Regimen B: Sequential Radiotherapy, Single-Agent Chemotherapy, and Stem Cell Rescue. Total-body irradiation, TBI (equipment not specified); Etoposide, VP-16, NSC-141540; and Peripheral Blood Stem Cells, PBSC.
PROJECTED ACCRUAL: 20 patients will be studied.
Eligibility
Ages Eligible for Study: 16 Years - 65 Years
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Pathologically confirmed non-Hodgkin's lymphomas of the following histologic subtypes: Small lymphocytic; Follicular small cleaved cell; Follicular mixed cell; Follicular large cell (relapsed)
- Disease in first, second, or third partial remission (25% shrinkage in cross-sectional area of measurable disease) or first, second, or subsequent relapse required
- Transformed non-Hodgkin's lymphoma eligible, i.e., low-grade lymphoma subsequently transformed to intermediate- or high-grade lymphoma
- No lymphosarcoma cell leukemia
--Prior/Concurrent Therapy--
- Biologic therapy: Not specified
- Chemotherapy: Not specified
- Endocrine therapy: Not specified
- Radiotherapy: Less than 3,500 cGy prior irradiation to the mediastinum, lungs, or spinal cord
- Surgery: Not specified
--Patient Characteristics--
- Age: 16 to 65
- Performance status: Karnofsky 80-100%
- Hematopoietic: WBC at least 5,000/mm3 (polys at least 2,000/mm3); Platelet count at least 100,000/mm3
- Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT no greater than 2 times normal
- Renal: Creatinine no greater than 1.8 mg/dL
- Cardiovascular: LVEF at least 50%
- Pulmonary: FVC greater than 1.5 liters; FEV1 greater than 1.2 liters; MVV greater than 50 liters; DLCO greater than 12 mL/min; pO2 greater than 70 mm Hg on room air
- Other: No other serious psychiatric, neurologic, or medical illness
Location Information
Thomas R. Klumpp, Study Chair, Temple University Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: August 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002510
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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