NCT00093821

Brief Summary

This phase I trial is studying the side effects and best dose of tanespimycin in treating young patients with recurrent or refractory leukemia or selected solid tumors. Drugs used in chemotherapy, such as tanespimycin, work in different ways to stop cancer cells from dividing so they stop growing or die.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P75+ 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

September 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2004

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

2.9 years

First QC Date

October 6, 2004

Last Update Submit

June 3, 2013

Conditions

Childhood Chronic Myelogenous LeukemiaChildhood Desmoplastic Small Round Cell TumorDisseminated NeuroblastomaMetastatic Childhood Soft Tissue SarcomaMetastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal TumorMetastatic OsteosarcomaPreviously Treated Childhood RhabdomyosarcomaRecurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Acute Myeloid LeukemiaRecurrent Childhood RhabdomyosarcomaRecurrent Childhood Soft Tissue SarcomaRecurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal TumorRecurrent NeuroblastomaRecurrent Osteosarcoma

Outcome Measures

Primary Outcomes (1)

  • MTD, defined as the highest dose level with an observed incidence of DLT in no more than 1 out of 6 patients treated at a particular dose level

    21 days

Secondary Outcomes (1)

  • Change in Hsp90 client protein levels in relation to dose of tanespimycin

    Baseline to 21 days

Study Arms (1)

Treatment (tanespimycin)

EXPERIMENTAL

Patients receive tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11 (for patients with solid tumors) OR days 1, 4, 8, 11, 15, and 18 (for patients with leukemia). Courses for all patients repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of tanespimycin until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 15 patients are treated at the MTD.

Drug: tanespimycinOther: pharmacological studyOther: laboratory biomarker analysis

Interventions

tanespimycinDRUG

Given IV

Also known as: 17-AAG
Treatment (tanespimycin)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (tanespimycin)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (tanespimycin)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed diagnosis of 1 of the following malignancies:
  • Leukemia
  • Lymphoid, myeloid, or mixed lineage
  • Relapsed (in second or greater relapse) or refractory disease, confirmed by 1 of the following:
  • Bone marrow relapse, defined as either M3 bone marrow (\> 25% blasts in the bone marrow aspirate) OR M2 bone marrow (5-25% blasts in the bone marrow aspirate) at any time after complete remission is attained
  • CNS relapse, defined as at least 5 WBC/mL by cytospin of any cerebrospinal fluid (CSF) specimen OR less than 5 WBC/mL by cytospin of 2 consecutive CSF specimens obtained \>= 4 weeks apart and having definitive confirmation that blasts are derived from the original leukemic clone by molecular cytogenetics, multiparameter flow cytometry, or immunostaining of \>= 2 antigens
  • Patients with underlying chronic myeloid leukemia must have \> 25% blasts in the bone marrow aspirate
  • Patients with M3 bone marrow AND extramedullary sites of disease, other than leptomeningeal disease, are eligible
  • Solid tumor
  • One of the following tumor types:
  • Neuroblastoma
  • Ewing's sarcoma
  • Osteosarcoma
  • Desmoplastic small round cell tumor
  • Rhabdomyosarcoma
  • +63 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Desmoplastic Small Round Cell TumorNeuroectodermal Tumors, Primitive, PeripheralOsteosarcomaPrecursor Cell Lymphoblastic Leukemia-LymphomaNeuroblastoma

Interventions

tanespimycin

Condition Hierarchy (Ancestors)

SarcomaNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeoplasms, Bone TissueNeoplasms, Connective TissueLeukemia, LymphoidLeukemiaHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Tanya Trippett

    Memorial Sloan Kettering Cancer Center

    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

October 6, 2004

First Posted

October 8, 2004

Study Start

September 1, 2004

Primary Completion

August 1, 2007

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

US(1)