NCT00002759

Brief Summary

Phase I trial to study the effectiveness of irinotecan plus cyclosporine and phenobarbital in treating patients who have solid tumors or lymphoma that is refractory to standard therapy. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Cyclosporine and phenobarbital may enhance the effectiveness of irinotecan.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_1

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

June 1, 1996

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2002

Completed
2 years until next milestone

First Posted

Study publicly available on registry

March 26, 2004

Completed
Last Updated

February 5, 2013

Status Verified

May 1, 2006

Enrollment Period

5.8 years

First QC Date

November 1, 1999

Last Update Submit

February 4, 2013

Conditions

Drug/Agent Toxicity by Tissue/OrganLymphomaNeutropeniaSmall Intestine CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomarecurrent adult Hodgkin lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomasmall intestine lymphomaunspecified adult solid tumor, protocol specificstage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III adult diffuse small cleaved cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III adult Burkitt lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult Burkitt lymphomarecurrent 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 lymphoblastic lymphomarecurrent adult Burkitt lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomarecurrent adult T-cell leukemia/lymphomaprimary central nervous system non-Hodgkin lymphomadrug/agent toxicity by tissue/organneutropeniaAIDS-related peripheral/systemic lymphomaAIDS-related primary CNS lymphomaintraocular lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomaangioimmunoblastic T-cell lymphomaanaplastic large cell lymphomastage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromerecurrent mycosis fungoides/Sezary syndromerecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Study Arms (1)

Arm I

EXPERIMENTAL

See detailed description.

Drug: cyclosporineDrug: irinotecan hydrochlorideDrug: phenobarbital

Interventions

cyclosporineDRUG
Arm I
irinotecan hydrochlorideDRUG
Arm I
phenobarbitalDRUG
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Malignant solid tumor or lymphoma refractory to standard therapy or for which no therapy of proven benefit exists * No leukemia * Measurable or evaluable disease PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: Karnofsky 70-100% * Life expectancy: At least 3 months * WBC at least 3,500/mm3 * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin at least 9 g/dL * Bilirubin no greater than 1.5 mg/dL * AST/ALT less than twice normal (unless due to disease) * PT and PTT normal * Creatinine no greater than 1.5 mg/dL * Creatinine clearance at least 60 mL/min * No history of congestive heart failure requiring medical therapy * No clinically significant or life threatening cardiac arrhythmia * No history of significant pulmonary disease or lymphangitic lung disease * No hypersensitivity to cyclosporine or cremophore * No history of manifest or latent porphyria or hypersensitivity to barbiturates (for parts of study using phenobarbital) * No history of inflammatory bowel disease requiring therapy * No chronic diarrhea syndrome or paralytic ileus * No medical or psychiatric condition that precludes informed consent * Not pregnant * Effective contraception required of fertile women PRIOR CONCURRENT THERAPY: * At least 4 weeks since prior biologic therapy * At least 2 weeks since prior colony stimulating factors * At least 4 weeks since prior chemotherapy (at least 6 weeks since nitrosoureas or mitomycin) * No prior bleomycin or irinotecan * At least 4 weeks since prior radiotherapy to greater than 25% of bone marrow * Minimum time interval between prior therapy and eligibility shortened by 2 weeks when phenobarbital is administered * Concurrent use of medications that affect the central nervous or cardiovascular systems (e.g., anticonvulsants, calcium channel blockers, oral contraceptives) must be approved by the Principal Investigator

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 Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsLymphomaNeutropeniaHodgkin DiseaseLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaIntraocular LymphomaLymphoma, Mantle-CellImmunoblastic LymphadenopathyLymphoma, Large-Cell, AnaplasticMycosis FungoidesSezary SyndromeLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

CyclosporineIrinotecanPhenobarbital

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesLeukocyte DisordersLymphoma, T-CellLymphoma, B-CellLeukemia, LymphoidLeukemiaEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsEye NeoplasmsNeoplasms by SiteLymphadenopathyLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsCamptothecinAlkaloidsHeterocyclic CompoundsBarbituratesPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Mark J. Ratain, MD

    University of Chicago

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

March 26, 2004

Study Start

June 1, 1996

Primary Completion

April 1, 2002

Last Updated

February 5, 2013

Record last verified: 2006-05

Locations

US(1)