Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial Description

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose and recommended phase II dose of ispinesib in pediatric patients with refractory solid tumors or lymphoma.

II. Define and describe the toxicities of ispinesib in these patients. III. Characterize the pharmacokinetics of ispinesib in these patients.

SECONDARY OBJECTIVES:

I. Define, preliminarily, the antitumor activity of ispinesib. II. Determine the relationship between CYP3A4 gene polymorphisms and pharmacokinetics in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive ispinesib IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of ispinesib until the maximum tolerated dose (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.

Patients undergo blood and tumor sample collection periodically for pharmacokinetic and gene polymorphism correlative studies.

After completion of study therapy, patients are followed for 30 days. ;


Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Astrocytoma
  • Brain Neoplasms
  • Burkitt Lymphoma
  • 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
  • Choroid Plexus Neoplasms
  • Craniopharyngioma
  • Ependymoma
  • Glioma
  • Lymphoma
  • Lymphoma, Extranodal NK-T-Cell
  • Lymphoma, Non-Hodgkin
  • Lymphomatoid Granulomatosis
  • Medulloblastoma
  • Meningioma
  • Neoplasms
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive
  • Optic Nerve Glioma
  • 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
  • Spinal Cord Neoplasms
  • Unspecified Childhood Solid Tumor, Protocol Specific

NCT number NCT00363272
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 1
Start date June 2006

See also
  Status Clinical Trial Phase
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Completed NCT01164163 - INCB18424 in Treating Young Patients With Relapsed or Refractory Solid Tumor, Leukemia, or Myeloproliferative Disease Phase 1
Terminated NCT00949117 - Cyproheptadine Hydrochloride and Nutritional Supplementation in Treating Young Patients With Weight Loss With Cancer Phase 2
Completed NCT00985868 - AT9283 in Children and Adolescents With Relapsed and Refractory Solid Tumors Phase 1
Completed NCT00281944 - Combination Chemotherapy in Treating Young Patients With Advanced Solid Tumors Phase 1
Completed NCT00253474 - PEG-Interferon Alfa-2b in Treating Young Patients With Plexiform Neurofibroma Phase 1
Recruiting NCT00084695 - Umbilical Cord Blood for Stem Cell Transplantation in Treating Young Patients With Malignant or Nonmalignant Diseases Phase 2
Completed NCT00053963 - FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia Phase 1
Completed NCT00003070 - Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer Phase 3
Completed NCT00004212 - DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas Phase 1
Completed NCT00004005 - Irinotecan Followed By Fluorouracil and Leucovorin in Treating Patients With Stage III or Stage IV Colorectal Carcinoma (Cancer), Other Refractory Carcinoma, or Metastatic Adenoma (Cancer) of Unknown Primary Origin Phase 2
Completed NCT00003754 - Thalidomide and Cyclophosphamide in Treating Children With Recurrent or Refractory Childhood Cancers Phase 2
Completed NCT00016861 - Irinotecan in Treating Children With Refractory or Progressive Solid Tumors Phase 1
Completed NCT00003173 - High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors Phase 2
Recruiting NCT00898794 - Effect of Bevacizumab and VEGF on Platelet Clustering in Patients Who Are Receiving Bevacizumab for Cancer N/A
Terminated NCT00429702 - Diphenhydramine, Lorazepam, and Dexamethasone in Treating Nausea and Vomiting Caused By Chemotherapy Phase 2
Completed NCT00459238 - Telephone-Based Cancer Education With or Without Telephone-Based Counseling in Young Participants N/A
Completed NCT00387920 - Sunitinib in Treating Young Patients With Refractory Solid Tumors Phase 1
Completed NCT00138216 - Temozolomide, Vincristine, and Irinotecan in Treating Young Patients With Refractory Solid Tumors Phase 1
Terminated NCT00176540 - Dextromethorphan in Treating Patients With Fatigue Caused by Cancer N/A