ABT-751 in Treating Young Patients With Refractory Solid Tumors

NCT00036959 | Completed Phase 1

• 4 other identifiers: 02014102-C-0141ABBOTT-M01-357CDR0000069344
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as ABT-751, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase I trial is studying the side effects of ABT-751 in treating young patients with refractory solid tumors.

Conditions

Brain and Central Nervous System Tumors; Childhood Germ Cell Tumor; Extragonadal Germ Cell Tumor; Kidney Cancer; Liver Cancer; Neuroblastoma; Ovarian Cancer; Sarcoma; Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

metastatic osteosarcoma; childhood infratentorial ependymoma; recurrent childhood rhabdomyosarcoma; childhood supratentorial ependymoma; childhood craniopharyngioma; disseminated neuroblastoma; recurrent neuroblastoma; recurrent childhood liver cancer; stage IV childhood liver cancer; recurrent Wilms tumor and other childhood kidney tumors; stage IV Wilms tumor; childhood central nervous system germ cell tumor; recurrent osteosarcoma; unspecified childhood solid tumor, protocol specific; childhood germ cell tumor; metastatic childhood soft tissue sarcoma; recurrent childhood soft tissue sarcoma; childhood high-grade cerebral astrocytoma; childhood oligodendroglioma; childhood choroid plexus tumor; childhood grade I meningioma; childhood grade II meningioma; childhood grade III meningioma; recurrent childhood cerebellar astrocytoma; recurrent childhood cerebral astrocytoma; recurrent childhood medulloblastoma; recurrent childhood visual pathway and hypothalamic glioma; previously treated childhood rhabdomyosarcoma; metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor; recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor; recurrent childhood ependymoma; childhood teratoma; childhood malignant testicular germ cell tumor; childhood malignant ovarian germ cell tumor; childhood extragonadal germ cell tumor; recurrent childhood malignant germ cell tumor

Interventions

ABT-751 DRUG

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor\*, including, but not limited to, the following: * Rhabdomyosarcoma * Other soft tissue sarcomas * Ewing's sarcoma family of tumors * Osteosarcoma * Neuroblastoma * Wilms' tumor * Hepatic tumors * Germ cell tumors * Primary brain tumors * Brain stem or optic gliomas (histological confirmation may be waived if a biopsy has not been performed) NOTE: \*Closed to accrual for all diagnoses except neuroblastoma as of 4/16/05 * Relapsed after or failed to respond to frontline standard therapy and no other standard treatment options (e.g., surgery, radiotherapy, chemotherapy, or any combination of these modalities) exist * Measurable or evaluable disease\* NOTE: \*Not required for patients with neuroblastoma * No CNS tumor with motor or sensory deficits that would obscure the study assessment of sensory neuropathy PATIENT CHARACTERISTICS: Age: * 18 and under Performance status: * Lansky 60-100% (age 10 and under) * Karnofsky 60-100% (age 11 to 18) Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * ALT and AST no greater than 2.5 times ULN (5 times ULN for patients treated after the maximum tolerated dose is determined) * No clinically significant hepatic dysfunction Renal: * Creatinine normal for age OR * Creatinine clearance at least 60 mL/min * No clinically significant renal dysfunction Cardiovascular: * LVEF normal by echocardiogram Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No allergy to sulfa-containing medications * No clinically significant unrelated systemic illness (e.g., other organ dysfunction) that would preclude study participation * No serious infection * No preexisting grade 2 or greater sensory or motor neuropathy * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 months since prior bone marrow transplantation * At least 72 hours since prior interleukin-11 * At least 72 hours since prior colony-stimulating factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) except epoetin alfa * No concurrent growth factors (e.g., GM-CSF) except epoetin alfa * Concurrent G-CSF allowed if neutropenia lasts longer than 5 days OR if the patient experiences confirmed septicemia associated with neutropenia * No concurrent immunotherapy * No concurrent interleukin-11 Chemotherapy: * See Disease Characteristics * At least 30 days since prior chemotherapy (42 days for nitrosoureas) * No other concurrent anticancer chemotherapy Endocrine therapy: * Patients with brain tumors: * Must be on a stable or tapering dose of corticosteroids for 7 days before baseline scan performed for the purpose of assessing response to study therapy * Concurrent corticosteroids allowed for control of symptoms of tumor-associated edema Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy * At least 4 months since prior extensive radiotherapy (craniospinal radiotherapy, total body irradiation, or radiotherapy to more than 50% of the pelvis) * No concurrent radiotherapy Surgery: * See Disease Characteristics Other: * Recovered from prior therapy * At least 30 days since prior investigational anticancer therapy * No other concurrent investigational agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Children's Memorial Hospital - Chicago

Chicago, Illinois, 60614, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-4318, United States

Location

Related Publications (3)

• Fox E, Maris JM, Cohn SL, Goodspeed W, Goodwin A, Kromplewski M, Medina D, Xiong H, Krivoshik A, Widemann B, Adamson PC, Balis FM. Pharmacokinetics of orally administered ABT-751 in children with neuroblastoma and other solid tumors. Cancer Chemother Pharmacol. 2010 Sep;66(4):737-43. doi: 10.1007/s00280-009-1218-z. Epub 2010 Jan 1.

  PMID: 20044751 RESULT

• Fox E, Maris JM, Widemann BC, Goodspeed W, Goodwin A, Kromplewski M, Fouts ME, Medina D, Cohn SL, Krivoshik A, Hagey AE, Adamson PC, Balis FM. A phase I study of ABT-751, an orally bioavailable tubulin inhibitor, administered daily for 21 days every 28 days in pediatric patients with solid tumors. Clin Cancer Res. 2008 Feb 15;14(4):1111-5. doi: 10.1158/1078-0432.CCR-07-4097.

  PMID: 18281544 RESULT

• Fox E, Maris JM, Widemann BC, Meek K, Goodwin A, Goodspeed W, Kromplewski M, Fouts ME, Medina D, Cho SY, Cohn SL, Krivoshik A, Hagey AE, Adamson PC, Balis FM. A phase 1 study of ABT-751, an orally bioavailable tubulin inhibitor, administered daily for 7 days every 21 days in pediatric patients with solid tumors. Clin Cancer Res. 2006 Aug 15;12(16):4882-7. doi: 10.1158/1078-0432.CCR-06-0534.

  PMID: 16914576 RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Kidney Neoplasms; Liver Neoplasms; Neuroblastoma; Ovarian Neoplasms; Sarcoma; Osteosarcoma; Wilms Tumor; Astrocytoma; Oligodendroglioma; Choroid Plexus Neoplasms; Medulloblastoma; Optic Nerve Glioma; Neuroectodermal Tumors, Primitive, Peripheral; Familial ependymoma; Teratoma; Testicular Neoplasms; Ovarian Germ Cell Cancer

Interventions

ABT751

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Connective and Soft Tissue; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Complex and Mixed; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Glioma; Cerebral Ventricle Neoplasms; Brain Neoplasms; Brain Diseases; Central Nervous System Diseases; Optic Nerve Neoplasms; Cranial Nerve Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Diseases; Optic Nerve Diseases; Eye Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Testicular Diseases

Study Officials

• Elizabeth Fox, MD

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 13, 2002
• First Posted: January 27, 2003
• Study Start: March 1, 2002
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: March 15, 2012

Record last verified: 2012-03

Locations

US (3)