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Irinotecan in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
irinotecan hydrochloride
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Waldenström macroglobulinemia, 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, recurrent adult Burkitt lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory non-Hodgkin's lymphoma First relapse requires histologic confirmation of relapse No CNS metastases No lymphomatous meningitis Measurable disease PATIENT CHARACTERISTICS: Age: 15-75 Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: Unless due to lymphoma: Platelet count at least 100,000/mm^3 Absolute granulocyte count at least 1,500/mm^3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if liver involvement) Renal: Creatinine no greater than 2.0 mg/dL Baseline calcium less than 12 mg/dL Cardiovascular: No myocardial infarction within 6 months No congestive heart failure requiring therapy Other: No history of seizures No uncontrolled diabetes mellitus (i.e., random blood sugar of at least 250 mg) No other concurrent severe disease No uncontrolled infection HIV negative No psychoses No prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cancer of the cervix unless surgically treated and disease free for at least 5 years Not pregnant or lactating Effective contraception required of fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplantation Chemotherapy: No more than 2 prior chemotherapy regimens for treatment of lymphoma No prior irinotecan, topotecan or aminocamptothecin At least 3 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Radiotherapy that is not a part of a combined-modality therapy is counted as a regimen (see Chemotherapy) Surgery: Not specified Other: No phenytoin, phenobarbital, or other antiepileptic prophylaxis

Sites / Locations

  • University of Texas - MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
November 13, 2018
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003245
Brief Title
Irinotecan in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma
Official Title
Phase II Study of Irinotecan for the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 18, 1998 (Actual)
Primary Completion Date
July 30, 2004 (Actual)
Study Completion Date
July 30, 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
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 irinotecan in treating patients with recurrent or refractory non-Hodgkin's lymphoma.
Detailed Description
OBJECTIVES: Determine the objective response rate and toxicity of irinotecan when administered to patients with recurrent or refractory non-Hodgkin's lymphoma. OUTLINE: Patients are stratified by disease category (aggressive vs indolent vs mantle cell lymphoma). Patients with aggressive and indolent lymphoma are further stratified as to being refractory (no complete response (CR) or partial response (PR) to initial therapy) vs recurrent (CR or PR to initial therapy); i.e, the following subcategories are used: Stratum I:Refractory aggressive non-Hodgkin's lymphoma (NHL) Stratum II:Recurrent aggressive NHL Stratum III: Refractory indolent NHL Stratum IV: Recurrent indolent NHL Stratum V: Mantle cell NHL All patients receive irinotecan intravenously every 21 days. Patients achieving CR or PR receive 6 courses. Patients may receive bone marrow transplantation after at least 2 courses. Patients are followed every 3 months for survival. PROJECTED ACCRUAL: This study will accrue 18 patients per stratum; if at least three patients respond, an additional 25 patients will be accrued for a total of 43 evaluable patients per stratum. The total number accrued will be 90-215 over a period of approximately 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Waldenström macroglobulinemia, 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, recurrent adult Burkitt lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone 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
50 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory non-Hodgkin's lymphoma First relapse requires histologic confirmation of relapse No CNS metastases No lymphomatous meningitis Measurable disease PATIENT CHARACTERISTICS: Age: 15-75 Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: Unless due to lymphoma: Platelet count at least 100,000/mm^3 Absolute granulocyte count at least 1,500/mm^3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if liver involvement) Renal: Creatinine no greater than 2.0 mg/dL Baseline calcium less than 12 mg/dL Cardiovascular: No myocardial infarction within 6 months No congestive heart failure requiring therapy Other: No history of seizures No uncontrolled diabetes mellitus (i.e., random blood sugar of at least 250 mg) No other concurrent severe disease No uncontrolled infection HIV negative No psychoses No prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cancer of the cervix unless surgically treated and disease free for at least 5 years Not pregnant or lactating Effective contraception required of fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplantation Chemotherapy: No more than 2 prior chemotherapy regimens for treatment of lymphoma No prior irinotecan, topotecan or aminocamptothecin At least 3 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Radiotherapy that is not a part of a combined-modality therapy is counted as a regimen (see Chemotherapy) Surgery: Not specified Other: No phenytoin, phenobarbital, or other antiepileptic prophylaxis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre Goy, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

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Irinotecan in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma

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