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Brain and Central Nervous System TumorsPhase 1NCT00036959

ABT-751 in Treating Young Patients With Refractory Solid Tumors

A Phase 1 study testing ABT-751 in people with Brain and Central Nervous System Tumors and Childhood Germ Cell Tumor, run by National Institutes of Health Clinical Center (CC) at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 18 years
What is being tested?
ABT-751
How many people
90 participants
Where
3 sitesUnited States
Study dates
Mar 2002to Feb 2010
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

    Bethesda, Maryland, 20892-1182

  • Children's Memorial Hospital - Chicago

    Chicago, Illinois, 60614

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104-4318

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
ABT-751
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
Medical subject headings
Central Nervous System Neoplasms, Kidney Neoplasms, Liver Neoplasms, Neuroblastoma, Ovarian Neoplasms, Sarcoma, Osteosarcoma, Wilms Tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABT-751Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startMar 2002
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00036959
Sponsor's protocol ID
020141
Other IDs
02-C-0141, ABBOTT-M01-357, CDR0000069344
Status last verified
Mar 2012
First submitted
13 May 2002
Last updated
15 Mar 2012
Results posted
No

Publications

  • 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.

    PubMed 20044751

  • 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.

    PubMed 18281544

  • 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.

    PubMed 16914576

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABT-751 in people with Brain and Central Nervous System Tumors and Childhood Germ Cell Tumor, run by National Institutes of Health Clinical Center (CC) at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00036959, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2012.

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Clinical Trial NCT00036959 | AzTrials