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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

filgrastim

cyclophosphamide

etoposide

mesna

peripheral blood stem cell transplantation

radiation therapy

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Waldenstrom macroglobulinemia, recurrent small lymphocytic lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 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

Sites / Locations

Temple University Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002510

First Posted

November 1, 1999

Last Updated

September 30, 2010

Sponsor

Temple University

Collaborators

Fox Chase Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00002510

Brief Title

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

Official Title

HIGH-DOSE CHEMORADIOTHERAPY FOLLOWED BY RESCUE WITH MOBILIZED AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH LOW-GRADE, TRANSFORMED, OR FOLLICULAR LARGE CELL NON-HODGKIN'S LYMPHOMA

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Completed

Study Start Date

April 1992 (undefined)

Primary Completion Date

June 2001 (Actual)

Study Completion Date

June 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Temple University

Collaborators

Fox Chase Cancer Center

4. Oversight

5. Study Description

Brief Summary

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.

Detailed Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma

Keywords

Waldenstrom macroglobulinemia, recurrent small lymphocytic lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

filgrastim

Intervention Type

Drug

Intervention Name(s)

cyclophosphamide

Intervention Type

Drug

Intervention Name(s)

etoposide

Intervention Type

Drug

Intervention Name(s)

mesna

Intervention Type

Procedure

Intervention Name(s)

peripheral blood stem cell transplantation

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility 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 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas R. Klumpp, MD

Organizational Affiliation

Fox Chase Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

Temple University Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Lymphoma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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