Ispinesib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Lymphoma

Completed · Phase 1

Conditions studied: Childhood Burkitt Lymphoma, Childhood Central Nervous System Germ Cell Tumor, Childhood Choroid Plexus Tumor, Childhood Craniopharyngioma, Childhood Grade I Meningioma, Childhood Grade II Meningioma, Childhood Grade III Meningioma, Childhood High-grade Cerebral Astrocytoma, Childhood Infratentorial Ependymoma, Childhood Low-grade Cerebral Astrocytoma, Childhood Spinal Cord Neoplasm, Childhood Supratentorial Ependymoma, Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Brain Tumor, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Ependymoma, Recurrent Childhood Grade III Lymphomatoid Granulomatosis, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Medulloblastoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor, Recurrent Childhood Visual Pathway and Hypothalamic Glioma, Unspecified Childhood Solid Tumor, Protocol Specific

In brief

This phase I trial is studying the side effects and best dose of ispinesib in treating young patients with relapsed or refractory solid tumors or lymphoma. Drugs used in chemotherapy, such as ispinesib, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing

Key facts

Study ID

NCT00363272

Run by

National Cancer Institute (NCI)

People needed

30

Starts

2006-06-01

Last updated by the study team

2013-01-16

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed malignancy at either original diagnosis or relapse, including the following:
• Solid tumor, including primary CNS tumors
• Neurologic deficits in patients with CNS tumors must have been relatively stable for ≥ 1 week
• Patients with CNS tumors must be on stable or decreasing doses of dexamethasone for the past 7 days
• Histology requirement waived for intrinsic brain stem tumors
• Lymphoma
• Measurable or evaluable disease
• No known curative therapy or no therapy proven to prolong survival with an acceptable quality of life exists
• Patients with known bone marrow metastases are eligible for study but are not evaluable for hematologic toxicity
• Not known to be refractory to red blood cell or platelet transfusions
• Karnofsky performance score (PS) 60-100% (> 10 years of age) or Lansky PS 60-100% (≤ 10 years of age)
• Absolute neutrophil count ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³ (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to study enrollment)
• Hemoglobin ≥ 8.0 g/dL (RBC transfusions allowed)
• Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine based on age as follows:
• No greater than 0.8 mg/dL (≤ 5 years of age)
• No greater than 1.0 mg/dL (6 to 10 years of age)
• No greater than 1.2 mg/dL (11 to 15 years of age)
• No greater than 1.5 mg/dL (> 15 years of age)
• Bilirubin ≤ 1.5 times upper limit of normal
• ALT ≤ 45 U/L
• Albumin ≥ 2 g/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Where it is running

• Children's Oncology Group — Arcadia, California, United States

Full record on ClinicalTrials.gov

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