ABT-751 in Treating Young Patients With Refractory Solid Tumors

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Brief Title

ABT-751 in Treating Young Patients With Refractory Solid Tumors

Official Title

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

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.
    

Detailed Description

      OBJECTIVES:

      Primary

        -  Determine the maximum tolerated dose and dose-limiting toxic effects of ABT-751
           administered daily for 7 days every 21 days or daily for 21 days every 28 days in
           children with refractory solid tumors.

        -  Determine the toxicity spectrum of these regimens in these patients.

        -  Determine the pharmacokinetics of these regimens in these patients.

        -  Evaluate the pharmacodynamics of this drug by measuring the fraction of tubulin that is
           polymerized in the peripheral blood mononuclear cells of these patients before and after
           receiving this drug.

      Secondary

        -  Quantify responses in patients treated with these regimens.

        -  Assess the effect of this drug on tumor vascularity and tumor blood flow using dynamic
           enhanced MRI in these patients.

      OUTLINE: This is an open-label, multicenter, dose-escalation study of 2 different schedules
      of ABT-751. Patients are assigned to 1 of 2 dosing schedules.

        -  Schedule 1 (closed to accrual as of 5/25/2009): Patients receive oral ABT-751 once daily
           on days 1-7. Courses repeat every 21 days in the absence of disease progression or
           unacceptable toxicity.

        -  Schedule 2 (closed to accrual as of 5/25/2009): Patients receive oral ABT-751 once daily
           on days 1-21. Courses repeat every 28 days in the absence of disease progression or
           unacceptable toxicity.

      On each schedule, cohorts of 3-6 patients receive escalating doses of ABT-751 until the
      maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
      which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined,
      up to 9 patients (a minimum of 3 patients age 11 and under and 3 patients age 12 to 18) are
      treated at the MTD.

      PROJECTED ACCRUAL: A maximum of 90 patients will be accrued for this study within 8 months.
    

Study Phase

Phase 1

Study Type

Interventional




Condition

Brain and Central Nervous System Tumors

Intervention

ABT-751


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

90

Start Date

March 2002

Completion Date

February 2010

Primary Completion Date

February 2010

Eligibility 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
      

Gender

All

Ages

N/A - 18 Years

Accepts Healthy Volunteers

No

Contacts

Elizabeth Fox, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00036959

Organization ID

020141

Secondary IDs

02-C-0141


Study Sponsor

National Institutes of Health Clinical Center (CC)

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Elizabeth Fox, MD, Principal Investigator, National Cancer Institute (NCI)


Verification Date

March 2012