NCT00006220

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Tretinoin may help hematologic cancer cells develop into normal white blood cells. PURPOSE: Phase I/II trial to study the effectiveness of arsenic trioxide with or without tretinoin in treating patients who have hematologic cancer that has not responded to previous therapy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_1 leukemia

Timeline
Completed

Started Jun 1999

Shorter than P25 for phase_1 leukemia

Geographic Reach
1 country

1 active site

Status
terminated

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, 1999

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2000

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2000

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2002

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

May 20, 2004

Completed
Last Updated

February 6, 2013

Status Verified

February 1, 2013

Enrollment Period

1.4 years

First QC Date

September 11, 2000

Last Update Submit

February 4, 2013

Conditions

LeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic Syndromes

Keywords

stage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomarecurrent adult Hodgkin lymphomarefractory multiple myelomarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiarelapsing chronic myelogenous leukemiablastic phase chronic myelogenous leukemiarefractory anemia with excess blastsrefractory anemia with excess blasts in transformationstage 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 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 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 lymphomapreviously treated myelodysplastic syndromesstage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomachildhood myelodysplastic syndromes

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT)

    28 days

  • Likelihood of complete (CR) or partial (PR) response following therapy

    6 months

Secondary Outcomes (3)

  • Explore the pharmacokinetics of arsenic trioxide alone and in combination with ATRA

  • Evaluate acute and chronic toxicities of arsenic trioxide alone and in combination with ATRA.

  • Determine the effects of arsenic trioxide alone and combined with ATRA on bcl-2, pml, and class I antigen expression and on apoptosis. Determine the effects of arsenic trioxide on T and B cell number and function

Study Arms (3)

Phase I

EXPERIMENTAL

Starting dose of arsenic trioxide of 0.15 mg/kg/day

Drug: arsenic trioxide

Phase II

EXPERIMENTAL

MTD of arsenic trioxide

Drug: arsenic trioxide

Treatment Failure

EXPERIMENTAL

Arsenic trioxide and tretinoin

Drug: arsenic trioxideDrug: tretinoin

Interventions

arsenic trioxideDRUG
Phase IPhase IITreatment Failure
tretinoinDRUG
Treatment Failure

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Patients with any of the following diagnoses: Acute lymphocytic leukemia OR acute myeloid leukemia Failed to achieve complete remission (CR) with induction chemotherapy OR Relapsed within one year of initial CR OR Relapsed after autologous or allogeneic transplant OR Any subsequent relapse OR Refractory following relapse CR2 or more (phase I only) Blastic phase chronic myelogenous leukemia Prior therapy allowed Myelodysplastic syndrome, including the following: Refractory anemia with excess blasts (RAEB) OR RAEB in transformation (high intermediate or high risk only) Relapsed after transplant CR2 or more (phase I only) Non-Hodgkin's lymphoma OR Hodgkin's disease Newly diagnosed or in first relapse and failed to achieve CR or partial remission after induction or salvage chemotherapy OR Second or later relapse OR Relapsed after transplant No disease that can be encompassed in a standard radiation port No asymptomatic, minimally symptomatic, or low grade lymphoma Multiple myeloma Symptomatic, progressive, or recurrent disease after treatment with alkylating agents, high dose corticosteroids, or anthracyclines OR Relapsed following transplant Not eligible for autologous or allogeneic transplant 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: 15 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 500/mm3\* Platelet count at least 50,000/mm3\* \*Unless caused by marrow infiltration by tumor No congenital bleeding disorder Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) SGOT less than 3 times ULN Renal: Creatinine clearance greater than 25 mL/min Cardiovascular: No myocardial infarction, stroke, or unstable angina within the past 12 months No uncompensated congestive heart failure Left ventricular ejection fraction at least 40% Other: No active infection HIV negative HTLV I/II negative Not pregnant Fertile patients must use effective contraception during and for 2 years following study PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Prior hydroxyurea allowed Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics Surgery: Not specified Other: At least 3 weeks since prior antileukemic therapy (except leukapheresis)

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

Sponsors & Collaborators

Study Sites (1)

Washington University Barnard Cancer Center

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesHodgkin DiseaseLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaBlast CrisisAnemia, Refractory, with Excess of BlastsLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaLymphoma, Mantle-Cell

Interventions

Arsenic TrioxideTretinoin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBone Marrow DiseasesLeukemia, MyeloidLeukemia, LymphoidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMyeloproliferative DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAnemia, RefractoryAnemiaLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Intervention Hierarchy (Ancestors)

ArsenicalsInorganic ChemicalsOxidesOxygen CompoundsVitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Officials

  • Randy A. Brown, MD

    Washington University Siteman Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2000

First Posted

May 20, 2004

Study Start

June 1, 1999

Primary Completion

November 1, 2000

Study Completion

February 1, 2002

Last Updated

February 6, 2013

Record last verified: 2013-02

Locations

US(1)