NCT00012181

Brief Summary

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase I trial to study the effectiveness of flavopiridol in treating children who have relapsed or refractory solid tumors or lymphoma.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 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

First Submitted

Initial submission to the registry

March 3, 2001

Completed
29 days until next milestone

Study Start

First participant enrolled

April 1, 2001

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Last Updated

July 2, 2013

Status Verified

July 1, 2013

Enrollment Period

3.8 years

First QC Date

March 3, 2001

Last Update Submit

July 1, 2013

Conditions

Recurrent Childhood Brain Stem GliomaRecurrent Childhood Cerebellar AstrocytomaRecurrent Childhood Cerebral AstrocytomaRecurrent Childhood EpendymomaRecurrent Childhood Large Cell LymphomaRecurrent Childhood Liver CancerRecurrent Childhood Lymphoblastic LymphomaRecurrent Childhood Malignant Germ Cell TumorRecurrent Childhood MedulloblastomaRecurrent Childhood RhabdomyosarcomaRecurrent Childhood Small Noncleaved Cell LymphomaRecurrent Childhood Soft Tissue SarcomaRecurrent Childhood Supratentorial Primitive Neuroectodermal TumorRecurrent Childhood Visual Pathway and Hypothalamic GliomaRecurrent Childhood Visual Pathway GliomaRecurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal TumorRecurrent NeuroblastomaRecurrent OsteosarcomaRecurrent RetinoblastomaRecurrent Wilms Tumor and Other Childhood Kidney TumorsRecurrent/Refractory Childhood Hodgkin LymphomaUnspecified Childhood Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

  • MTD defined as the dose at which fewer than one-third of patients experience DLT assessed using Common Toxicity Criteria version 2.0

    Day 21

Study Arms (1)

Treatment (alvocidib)

EXPERIMENTAL

Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: alvocidibOther: pharmacological study

Interventions

alvocidibDRUG

Given IV

Also known as: FLAVO, flavopiridol, HMR 1275, L-868275
Treatment (alvocidib)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (alvocidib)

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Histologically confirmed relapsed or refractory solid tumor or lymphoma including:
  • Neuroblastoma
  • Osteosarcoma
  • Ewing's sarcoma
  • Rhabdomyosarcoma
  • Wilms tumor
  • CNS tumors
  • Histological verification not required for brainstem tumors
  • No acute leukemia
  • Not eligible for higher priority COG phase I/II study
  • Performance status - Karnofsky 50-100% (over age 10)
  • Performance status - Lansky 50-100% (age 10 and under)
  • At least 2 months
  • Absolute neutrophil count at least 1,000/mm\^3
  • Platelet count at least 75,000/mm\^3 (transfusion independent)
  • +33 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

COG Phase I Consortium

Arcadia, California, 91006-3776, United States

Location

MeSH Terms

Conditions

AstrocytomaFamilial ependymomaDendritic Cell Sarcoma, InterdigitatingMedulloblastomaBurkitt LymphomaOptic Nerve GliomaNeuroectodermal Tumors, Primitive, PeripheralNeuroblastomaOsteosarcomaRetinoblastomaWilms TumorRecurrence

Interventions

alvocidib

Condition Hierarchy (Ancestors)

GliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueHistiocytic Disorders, MalignantHistiocytosisLymphatic DiseasesHemic and Lymphatic DiseasesNeuroectodermal Tumors, PrimitiveEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesOptic Nerve NeoplasmsCranial Nerve NeoplasmsNervous System NeoplasmsNeoplasms by SitePeripheral Nervous System NeoplasmsCranial Nerve DiseasesNervous System DiseasesOptic Nerve DiseasesEye DiseasesNeoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueSarcomaRetinal NeoplasmsEye NeoplasmsEye Diseases, HereditaryRetinal DiseasesNeoplasms, Complex and MixedKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplastic Syndromes, HereditaryFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • James Whitlock

    COG Phase I Consortium

    PRINCIPAL INVESTIGATOR

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

March 3, 2001

First Posted

January 27, 2003

Study Start

April 1, 2001

Primary Completion

January 1, 2005

Last Updated

July 2, 2013

Record last verified: 2013-07

Locations

US(1)