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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003245
Recruitment Status : Completed
First Posted : September 24, 2003
Last Update Posted : October 8, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: irinotecan hydrochloride Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Irinotecan for the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
Study Start Date : February 1998
Actual Primary Completion Date : July 2004
Actual Study Completion Date : July 2004

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Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed recurrent or refractory non-Hodgkin's lymphoma

    • First relapse requires histologic confirmation of relapse
  • No CNS metastases
  • No lymphomatous meningitis
  • Measurable disease



  • 15-75

Performance status:

  • Zubrod 0-2

Life expectancy:

  • At least 12 weeks


  • 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


  • 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)


  • Creatinine no greater than 2.0 mg/dL
  • Baseline calcium less than 12 mg/dL


  • No myocardial infarction within 6 months
  • No congestive heart failure requiring therapy


  • 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


Biologic therapy:

  • No prior bone marrow transplantation


  • 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


  • 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)


  • Not specified


  • No phenytoin, phenobarbital, or other antiepileptic prophylaxis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003245

United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Andre Goy, MD M.D. Anderson Cancer Center

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00003245     History of Changes
Other Study ID Numbers: CDR0000066124
DM97-182 ( Other Identifier: UT MD Anderson Cancer Center )
First Posted: September 24, 2003    Key Record Dates
Last Update Posted: October 8, 2012
Last Verified: October 2012

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action