NCT00005626

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have newly diagnosed or relapsed non-Hodgkin's lymphoma or leukemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2 leukemia

Timeline
Completed

Started Feb 1998

Typical duration for phase_2 leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1998

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2000

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
9 months until next milestone

First Posted

Study publicly available on registry

August 10, 2004

Completed
Last Updated

September 25, 2012

Status Verified

September 1, 2012

Enrollment Period

5.8 years

First QC Date

May 2, 2000

Last Update Submit

September 24, 2012

Conditions

LeukemiaLymphoma

Keywords

stage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarefractory chronic lymphocytic leukemiastage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomaprolymphocytic leukemiastage I mantle cell lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II mantle cell lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomanoncontiguous stage II small lymphocytic lymphomanoncontiguous stage II marginal zone lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage I marginal zone lymphomastage I small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomacontiguous stage II marginal zone lymphomacontiguous stage II small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate (ORR)

    Objective Response Rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Determine the complete and partial response rates in patients with newly diagnosed or relapsed indolent non-Hodgkin's lymphoma, high risk chronic lymphocytic leukemia, or prolymphocytic leukemia treated with irinotecan.

    5 years

Secondary Outcomes (1)

  • Number of Participants with Adverse Events

    5 years

Study Arms (1)

Irinotecan Treatment

EXPERIMENTAL

Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed for survival.

Drug: Irinotecan

Interventions

IrinotecanDRUG

Irinotecan as outlined in treatment arm

Also known as: irinotecan hydrochloride, Camptosar CPT-11
Irinotecan Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven newly diagnosed or relapsed non-Hodgkin's lymphoma (NHL) of 1 of the following types: Low grade (diffuse small lymphocytic/marginal zone, grade I follicular small cleaved cell, or grade II follicular mixed cell) OR Mantle cell OR Histologically proven newly diagnosed or relapsed stage III or IV chronic lymphocytic leukemia (CLL) or prolymphocytic leukemia (PLL) At least 1 measurable disease parameter Enlarged spleen extending at least 2 cm below the costal margin constitutes measurable disease provided that no explanation other than lymphomatous involvement is likely Enlarged liver extending at least 5 cm below the costal margin constitutes measurable disease Not allowable as sole indication for therapy: Isolated splenomegaly OR Isolated hepatomegaly No central nervous system (CNS) metastases or carcinomatous meningitis A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy: At least 12 weeks Hematopoietic: NHL: Granulocyte count greater than 1,500/mm\^3 Hemoglobin at least 9.0 g/dL Platelet count greater than 100,000/mm\^3 CLL or PLL: Granulocyte count greater than 500/mm\^3 Hemoglobin greater than 7.0 g/dL Platelet count greater than 50,000/mm\^3 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 tumor present) No Gilbert's disease Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 60 mL/min Calcium less than 12.0 mg/dL (corrected) Cardiovascular: No myocardial infarction or atrial fibrillation within the past 6 months No congestive heart failure requiring therapy Other: No active or uncontrolled infection HIV negative No psychiatric disorder that would preclude informed consent or compliance No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of seizures No uncontrolled diabetes mellitus, defined as random blood glucose at least 200 mg/dL No other severe concurrent disease that would increase risk PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior irinotecan or any other topoisomerase I inhibitor (e.g., topotecan) Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaLeukemia, Lymphocytic, Chronic, B-CellLymphoma, FollicularLeukemia, ProlymphocyticLymphoma, Mantle-CellLymphoma, B-Cell, Marginal Zone

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, Non-HodgkinLymphoma, B-Cell

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Steven C. Goldstein, M.D.

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2000

First Posted

August 10, 2004

Study Start

February 1, 1998

Primary Completion

November 1, 2003

Study Completion

November 1, 2003

Last Updated

September 25, 2012

Record last verified: 2012-09

Locations

US(1)