NCT00003245

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_2 lymphoma

Timeline
Completed

Started Feb 1998

Typical duration for phase_2 lymphoma

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 18, 1998

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.9 years until next milestone

First Posted

Study publicly available on registry

September 24, 2003

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2004

Completed
Last Updated

November 15, 2018

Status Verified

November 1, 2018

Enrollment Period

6.4 years

First QC Date

November 1, 1999

Last Update Submit

November 13, 2018

Conditions

Lymphoma

Keywords

Waldenström macroglobulinemiarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult Burkitt lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

irinotecan hydrochlorideDRUG

Eligibility Criteria

Age15 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

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

Sponsors & Collaborators

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

LymphomaWaldenstrom MacroglobulinemiaLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic DisordersLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, B-CellLeukemia, LymphoidLeukemiaChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Andre Goy, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

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

November 1, 1999

First Posted

September 24, 2003

Study Start

February 18, 1998

Primary Completion

July 30, 2004

Study Completion

July 30, 2004

Last Updated

November 15, 2018

Record last verified: 2018-11

Locations

US(1)