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Phase II Study of Irinotecan for the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma

Phase 2
15 Years
75 Years
Not Enrolling

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Trial Information

Phase II Study of Irinotecan for the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma


- 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.

Inclusion Criteria


- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Andre Goy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

February 1998

Completion Date:

July 2004

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, Non-Hodgkin



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009