NCT00458744

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as talotrexin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of talotrexin in treating young patients with recurrent solid tumors or leukemia that is recurrent or does not respond to treatment.

Trial Health

10
At Risk

Trial Health Score

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

Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Last Updated

August 8, 2014

Status Verified

August 1, 2014

Enrollment Period

1.4 years

First QC Date

April 9, 2007

Last Update Submit

August 7, 2014

Conditions

Brain and Central Nervous System TumorsLeukemiaLymphomaUnspecified Childhood Solid Tumor, Protocol Specific

Keywords

juvenile myelomonocytic leukemiarelapsing chronic myelogenous leukemiaunspecified childhood solid tumor, protocol specificchildhood chronic myelogenous leukemiachildhood acute promyelocytic leukemia (M3)recurrent childhood acute lymphoblastic leukemiarecurrent childhood acute myeloid leukemiachildhood central nervous system germ cell tumorchildhood choroid plexus tumorchildhood craniopharyngiomachildhood infratentorial ependymomachildhood grade I meningiomachildhood grade II meningiomachildhood grade III meningiomachildhood supratentorial ependymomarecurrent childhood brain stem gliomarecurrent childhood cerebellar astrocytomarecurrent childhood cerebral astrocytomarecurrent childhood ependymomarecurrent childhood medulloblastomarecurrent childhood supratentorial primitive neuroectodermal tumorsrecurrent childhood visual pathway and hypothalamic gliomarecurrent childhood visual pathway gliomahigh-grade childhood cerebral astrocytomalow-grade childhood cerebral astrocytomarecurrent childhood brain tumorchildhood spinal cord tumorrecurrent/refractory childhood Hodgkin lymphomastage IV childhood Hodgkin lymphomarecurrent childhood large cell lymphomastage IV childhood large cell lymphomarecurrent childhood lymphoblastic lymphomastage IV childhood lymphoblastic lymphomarecurrent childhood small noncleaved cell lymphomastage IV childhood small noncleaved cell lymphomachildhood grade III lymphomatoid granulomatosischildhood nasal type extranodal NK/T-cell lymphomarecurrent childhood grade III lymphomatoid granulomatosisrecurrent childhood pineoblastoma

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose of talotrexin

  • Toxicity

Secondary Outcomes (2)

  • Antitumor activity

  • Tolerability

Interventions

talotrexinDRUG
chemotherapyPROCEDURE

Eligibility Criteria

Age1 Year - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Diagnosis of either of the following: * Recurrent solid tumor * Histologically confirmed\* malignancy at original diagnosis or relapse * Measurable or evaluable disease * Lymphoma or primary CNS tumor allowed * Patients with CNS tumors must be on a stable or decreasing dose of dexamethasone for the past 7 days * Recurrent or refractory leukemia * Confirmed relapse, as defined by M3 marrow (25% blasts in bone marrow aspirate or biopsy) * Active extramedullary disease allowed provided there is no leptomeningeal involvement NOTE: \*Histological confirmation not required for intrinsic brain stem tumors * Bone marrow metastases allowed * Not refractory to red blood cell or platelet transfusion * No pleural effusion or significant ascites * No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists * No Down syndrome PATIENT CHARACTERISTICS: * Karnofsky performance status (PS) 50-100% (for patients \> 10 years of age) OR Lansky PS 50-100% (for patients ≤ 10 years of age) * Absolute neutrophil count ≥ 1,000/mm³ (for patients with solid tumors without bone marrow involvement) * Platelet count ≥ 100,000/mm³ (transfusion independent) * Hemoglobin ≥ 8.0 g/dL * Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine adjusted according to age as follows: * No greater than 0.6 mg/dL (1 year to 23 months) * No greater than 0.8 mg/dL (2 to 5 years) * No greater than 1.0 mg/dL (6 to 9 years) * No greater than 1.2 mg/dL (10 to 12 years) * No greater than 1.4 mg/dL (13 years and over \[female\]) * No greater than 1.5 mg/dL (13 to 15 years \[male\]) * No greater than 1.7 mg/dL (16 years and over \[male\]) * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * ALT ≤ 110 U/L (ULN is 45 U/L) * Albumin ≥ 2 g/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled infection * No known condition that, in the opinion of the investigator, would preclude study compliance PRIOR CONCURRENT THERAPY: * Recovered from all prior treatment-related toxicity * At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) (for patients with solid tumors) * At least 24 hours since prior cytoreduction therapy initiated with hydroxyurea (for patients with leukemia) * At least 2 weeks since prior local palliative radiotherapy (small port) * At least 6 months since prior total-body irradiation (TBI), craniospinal radiotherapy, or ≥ 50% radiotherapy to the pelvis * At least 6 weeks since prior substantial bone marrow radiotherapy * At least 3 months since prior stem cell transplant or rescue without TBI * No evidence of active graft-versus-host disease * At least 7 days since prior growth factor therapy * At least 7 days since prior biological therapy * No nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin or other salicylates, penicillins, sulfa drugs (bactrim, septra), ciprofloxacin, tetracycline, thiazide diuretics, or probenecid within 2 days prior to, during, or within 5 days after treatment with talotrexin * No long-acting NSAIDs (e.g., nabumetone, naproxen, oxaprozin, piroxicam) within 5 days prior to, during, or within 5 days after treatment with talotrexin * No concurrent investigational drugs * No concurrent anticancer agents or therapy (e.g., chemotherapy, radiotherapy, immunotherapy, or biologic therapy)

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

Sponsors & Collaborators

MeSH Terms

Conditions

Central Nervous System NeoplasmsLeukemiaLymphomaLeukemia, Myelomonocytic, JuvenilePrecursor Cell Lymphoblastic Leukemia-LymphomaChoroid Plexus NeoplasmsAstrocytomaFamilial ependymomaMedulloblastomaOptic Nerve GliomaSpinal Cord NeoplasmsRecurrenceDendritic Cell Sarcoma, InterdigitatingBurkitt LymphomaLymphoma, Extranodal NK-T-Cell

Interventions

N(alpha)-(4-amino-4-deoxypteroyl)-N(delta)-hemiphthaloyl-L-ornithineDrug Therapy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, MyeloidMyelodysplastic-Myeloproliferative DiseasesBone Marrow DiseasesLeukemia, LymphoidCerebral Ventricle NeoplasmsBrain NeoplasmsBrain DiseasesCentral Nervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal Tumors, PrimitiveOptic Nerve NeoplasmsCranial Nerve NeoplasmsPeripheral Nervous System NeoplasmsCranial Nerve DiseasesOptic Nerve DiseasesEye DiseasesSpinal Cord DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHistiocytic Disorders, MalignantHistiocytosisEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphoma, T-Cell

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • James Croop, MD, PhD

    Riley's Children Cancer Center at Riley Hospital for Children

    STUDY CHAIR

  • Sultan Ahmed Pradhan, MD

    Tata Memorial Hospital

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2007

First Posted

April 11, 2007

Study Start

February 1, 2007

Primary Completion

July 1, 2008

Last Updated

August 8, 2014

Record last verified: 2014-08