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Etoposide in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Etoposide phosphate
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

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, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically documented non-Hodgkin's lymphoma Needle or core biopsy not acceptable as sole means of diagnosis No mantle cell or transformed lymphoma One of the following International Working Formulation (IWF) histologic subtypes required: Small lymphocytic with absolute lymphocytic count less than 5,000 (IWF A) Follicular, predominately small cleaved cell (IWF B) Follicular, mixed (IWF C) Follicular, large cell (IWF D) Diffuse, small cleaved cell (IWF E) Diffuse, mixed (IWF F) Diffuse, large cell (IWF G) Large cell, immunoblastic (IWF H) Recurrent or refractory disease treated with no more than 4 prior chemotherapy regimens Rebiopsy of a node at first relapse recommended Prior etoposide (oral or intravenous) allowed if given for no more than 5 days every 3 weeks The following are considered 1 prior therapy each: Identical drugs given on 2 different schedules Bone marrow transplant preparative regimen (single cycle of chemotherapy used solely to mobilize peripheral blood stem cells considered part of preparative regimen) Ineligible for protocol CLB-9551 (aminocamptothecin) Measurable disease by physical exam or imaging study required Indicator lesion larger than 1 x 1 cm No prior radiotherapy to indicator lesion unless progression clearly documented The following are not considered measurable: Barium study Ascites or pleural effusions Bony disease Bone marrow involvement No known parenchymal or leptomeningeal CNS disease Lumbar puncture not required prior to study PATIENT CHARACTERISTICS: Age: Not specified Performance status: CALGB 0-2 Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal Renal: Creatinine no greater than 1.5 times normal Other: HIV negative (testing required for patients at risk) No uncontrolled infection No other serious medical condition that would interfere with evaluation of study agent No psychiatric condition that would preclude protocol completion or informed consent No second malignancy within 5 years except curatively treated: Basal cell skin cancer Cervical cancer Not pregnant or nursing Adequate contraception required of fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (3 weeks for nitrosoureas, melphalan, or mitomycin) Endocrine therapy: No concurrent corticosteroids except for physiologic replacement Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Not specified Other: No other concurrent investigational agent

Sites / Locations

  • University of Minnesota Cancer Center
  • Washington University Barnard Cancer Center
  • St. Joseph's Hospital and Medical Center
  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Etoposide

Arm Description

Oral etoposide for relapsed or refractory non-Hodgkin's lymphoma

Outcomes

Primary Outcome Measures

Pharmacodynamics of etoposide

Secondary Outcome Measures

Response

Full Information

First Posted
November 1, 1999
Last Updated
June 27, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002880
Brief Title
Etoposide in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
Official Title
PHASE II STUDY OF ORAL ETOPOSIDE WITH PHARMACODYNAMIC MODELING IN RELAPSED NON-HODGKIN'S LYMPHOMA (IWF GRADES A-H)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
November 1996 (undefined)
Primary Completion Date
January 2001 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of etoposide in treating patients with relapsed non-Hodgkin's lymphoma.
Detailed Description
OBJECTIVES: I. Evaluate the response rate and response duration in patients with relapsed non-Hodgkin's lymphoma when treated with daily oral etoposide. II. Describe the toxic effects of daily oral etoposide in these patients. III. Monitor etoposide trough levels and determine whether etoposide concentrations correlate with age, response, and toxicity. OUTLINE: Patients receive oral etoposide daily for 21 days. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients in complete or partial remission receive 2 courses past best response (minimum 6 courses). Patients with stable disease after 3 courses may be removed from study. Patients are followed every 6 months for 2 years, then annually for survival. PROJECTED ACCRUAL: Approximately 97 patients will be accrued for this study over 2 years.

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, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Etoposide
Arm Type
Experimental
Arm Description
Oral etoposide for relapsed or refractory non-Hodgkin's lymphoma
Intervention Type
Drug
Intervention Name(s)
Etoposide phosphate
Intervention Description
50 mg PO q day for 21 days; repeat every 28 days escalate dose to 100 mg PO q day if ANC remains greater than 1500/microliter during cycle 1: no specified maximum of cycles if PR or CR
Primary Outcome Measure Information:
Title
Pharmacodynamics of etoposide
Time Frame
days 8, 15, and 22 of tx
Secondary Outcome Measure Information:
Title
Response
Time Frame
Day 1 of ea cycle, then q 6 mon/2 yrs then yearly until death or ds progression

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically documented non-Hodgkin's lymphoma Needle or core biopsy not acceptable as sole means of diagnosis No mantle cell or transformed lymphoma One of the following International Working Formulation (IWF) histologic subtypes required: Small lymphocytic with absolute lymphocytic count less than 5,000 (IWF A) Follicular, predominately small cleaved cell (IWF B) Follicular, mixed (IWF C) Follicular, large cell (IWF D) Diffuse, small cleaved cell (IWF E) Diffuse, mixed (IWF F) Diffuse, large cell (IWF G) Large cell, immunoblastic (IWF H) Recurrent or refractory disease treated with no more than 4 prior chemotherapy regimens Rebiopsy of a node at first relapse recommended Prior etoposide (oral or intravenous) allowed if given for no more than 5 days every 3 weeks The following are considered 1 prior therapy each: Identical drugs given on 2 different schedules Bone marrow transplant preparative regimen (single cycle of chemotherapy used solely to mobilize peripheral blood stem cells considered part of preparative regimen) Ineligible for protocol CLB-9551 (aminocamptothecin) Measurable disease by physical exam or imaging study required Indicator lesion larger than 1 x 1 cm No prior radiotherapy to indicator lesion unless progression clearly documented The following are not considered measurable: Barium study Ascites or pleural effusions Bony disease Bone marrow involvement No known parenchymal or leptomeningeal CNS disease Lumbar puncture not required prior to study PATIENT CHARACTERISTICS: Age: Not specified Performance status: CALGB 0-2 Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal Renal: Creatinine no greater than 1.5 times normal Other: HIV negative (testing required for patients at risk) No uncontrolled infection No other serious medical condition that would interfere with evaluation of study agent No psychiatric condition that would preclude protocol completion or informed consent No second malignancy within 5 years except curatively treated: Basal cell skin cancer Cervical cancer Not pregnant or nursing Adequate contraception required of fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (3 weeks for nitrosoureas, melphalan, or mitomycin) Endocrine therapy: No concurrent corticosteroids except for physiologic replacement Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Not specified Other: No other concurrent investigational agent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Bartlett, MD
Organizational Affiliation
Washington University Siteman Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Washington University Barnard Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. Joseph's Hospital and Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States

12. IPD Sharing Statement

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Etoposide in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

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