NCT00003395

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of arsenic trioxide in treating patients who have advanced hematologic cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 1998

Shorter than P25 for phase_1 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

April 1, 1998

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2000

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

August 16, 2004

Completed
Last Updated

June 25, 2013

Status Verified

June 1, 2013

Enrollment Period

1.9 years

First QC Date

November 1, 1999

Last Update Submit

June 24, 2013

Conditions

LeukemiaLymphomaMultiple Myeloma and Plasma Cell Neoplasm

Keywords

stage IV adult Hodgkin lymphomarecurrent adult Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarefractory multiple myelomaWaldenström macroglobulinemiastage III multiple myelomastage IV chronic lymphocytic leukemiarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiarelapsing chronic myelogenous leukemiarefractory chronic lymphocytic leukemiachronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiameningeal chronic myelogenous leukemiaadult acute erythroid leukemia (M6)adult acute myeloblastic leukemia without maturation (M1)adult acute myeloblastic leukemia with maturation (M2)adult acute myelomonocytic leukemia (M4)adult acute monoblastic leukemia (M5a)adult acute eosinophilic leukemiaadult acute basophilic leukemiaadult acute megakaryoblastic leukemia (M7)progressive hairy cell leukemia, initial treatmentrefractory hairy cell leukemiaacute undifferentiated leukemiastage 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 IV adult T-cell leukemia/lymphomarecurrent adult T-cell leukemia/lymphomasecondary acute myeloid leukemiaadult acute monocytic leukemia (M5b)primary central nervous system non-Hodgkin lymphomaAIDS-related peripheral/systemic lymphomaAIDS-related primary CNS lymphomaadult acute minimally differentiated myeloid leukemia (M0)intraocular lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomaanaplastic large cell lymphomastage IV mycosis fungoides/Sezary syndromerecurrent mycosis fungoides/Sezary syndromejuvenile myelomonocytic leukemiarecurrent marginal zone lymphomarecurrent small lymphocytic 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

Interventions

arsenic trioxideDRUG

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven hematologic cancer, including acute or chronic leukemia, malignant lymphoma, or multiple myeloma Exclude acute promyelocytic leukemia (M3) Relapse from or resistance to at least one course of standard anticancer therapy and lack of alternative therapy that has proven to be curative in the underlying disease PATIENT CHARACTERISTICS: Age: 17 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.5 mg/dL Renal: Creatinine no greater than 2.5 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception during and for at least 4 months after study No history of grand mal seizures (other than infantile febrile seizures) No active serious infections that are not controlled by antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational agents

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellHodgkin DiseaseLymphoma, T-Cell, CutaneousWaldenstrom MacroglobulinemiaLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseBlast CrisisLeukemia, Erythroblastic, AcuteLeukemia, Myelomonocytic, AcuteLeukemia, Monocytic, AcuteLeukemia, Eosinophilic, AcuteLeukemia, Basophilic, AcuteLeukemia, Megakaryoblastic, AcuteLeukemia, Hairy CellLeukemia, Biphenotypic, AcuteLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaIntraocular LymphomaLymphoma, Mantle-CellLymphoma, Large-Cell, AnaplasticMycosis FungoidesSezary SyndromeLeukemia, Myelomonocytic, JuvenileLymphoma, B-Cell, Marginal Zone

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLymphoma, T-CellLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, MyeloidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMyeloproliferative DisordersBone Marrow DiseasesCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsEye NeoplasmsNeoplasms by SiteMyelodysplastic-Myeloproliferative Diseases

Intervention Hierarchy (Ancestors)

ArsenicalsInorganic ChemicalsOxidesOxygen Compounds

Study Officials

  • Steven Soignet, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 16, 2004

Study Start

April 1, 1998

Primary Completion

March 1, 2000

Study Completion

March 1, 2000

Last Updated

June 25, 2013

Record last verified: 2013-06

Locations

US(1)