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Chemotherapy and Radiation Therapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma - Article


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Waldenström's Macroglobulinemia


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.

Sponsored by: Temple University Cancer Center
Information provided by: National Cancer Institute (NCI)

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

Further Study Details: 

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--

--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


Pennsylvania
      Temple University Cancer Center, Philadelphia,  Pennsylvania,  19140,  United States

Study chairs or principal investigators

Thomas R. Klumpp,  Study Chair,  Temple University Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000078066; TUHSC-2049; NCI-V92-0206
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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October 12, 2008



Page Updated: September 23, 2004
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