Clinical trial · Interventional
ABT-751 in Treating Young Patients With Refractory Solid Tumors
Phase I Trial and Pharmacokinetic Study of ABT-751, an Orally Bioavailable Tubulin Binding Agent, on a 7 Day and 21 Day Dosing Schedule in Pediatric Patients With Refractory Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Childhood Germ Cell Tumor | Childhood Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Extragonadal Germ Cell Tumor | Extragonadal Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABT-751 | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- RESULTFox 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
- RESULTFox 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
- RESULTFox 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