Clinical trial NCT00003245: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-09-24
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Andre Goy, MD
role: STUDY_CHAIR
References: