Tanespimycin in Treating Young Patients With Recurrent or Refractory Leukemia or Solid Tumors
Completed · Phase 1
Conditions studied: Childhood Chronic Myelogenous Leukemia, Childhood Desmoplastic Small Round Cell Tumor, Disseminated Neuroblastoma, Metastatic Childhood Soft Tissue Sarcoma, Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Metastatic Osteosarcoma, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Neuroblastoma, Recurrent Osteosarcoma
In brief
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.
Key facts
- Study ID
- NCT00093821
- Run by
- National Cancer Institute (NCI)
- People needed
- 70
- Starts
- 2004-09-01
- Last updated by the study team
- 2013-06-04
Who can join
Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.
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
- Progressed after prior standard therapy OR no effective standard therapy exists
- Measurable or nonmeasurable disease
- No known brain metastases
- No active leptomeningeal leukemia, defined by the following criteria:
- WBC > 5/mm\^3 in cerebrospinal fluid (CSF)
- Unequivocal confirmation of leukemic blasts in CSF by cell morphology
- No symptomatic CNS disease (e.g., cranial nerve abnormalities) without cytologic abnormality in CSF
- Performance status - Karnofsky 70-100% (for patients > 10 years of age)
- Performance status - Lansky 70-100% (for patients =< 10 years of age)
- More than 8 weeks
Where it is running
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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