ABT-751 in Treating Young Patients With Refractory Solid Tumors

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institutes of Health Clinical Center (CC)
• Collaborator: National Cancer Institute (NCI)

Criteria

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