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

NCT ID: NCT00003245

Last Updated: 2018-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-02-18
• Study Completion Date: 2004-07-30

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

irinotecan hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andre Goy, MD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Locations

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

MDA-DM-97182

Identifier Type: -

Identifier Source: secondary_id

NCI-T97-0103

Identifier Type: -

Identifier Source: secondary_id

DM97-182

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000066124

Identifier Type: -

Identifier Source: org_study_id