XK469 in Treating Patients With Advanced Neuroblastoma - Full Text View

Sponsor:	University of Chicago
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00028522

Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: This phase I trial is studying the side effects and best dose of XK469 in treating patients with advanced neuroblastoma.

Condition	Intervention	Phase
Neuroblastoma	Drug: R(+)XK469	Phase I

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase I Study Of R(+)XK469 In Patients With Advanced Neuroblastoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Neuroblastoma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Maximum tolerated dose [ Designated as safety issue: Yes ]
Dose-limiting toxicity [ Designated as safety issue: Yes ]
Recommended phase II dose [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Metabolism [ Designated as safety issue: No ]
Pharmacokinetics [ Designated as safety issue: No ]
Pharmacodynamics [ Designated as safety issue: No ]
Antineoplastic activity [ Designated as safety issue: No ]

Estimated Enrollment:	85
Study Start Date:	November 2001
Estimated Primary Completion Date:	December 2004 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the maximum tolerated dose, recommended phase II dose, and dose-limiting toxicity of R(+)XK469 in two different dosing schedules in patients with advanced neuroblastoma.
Determine the safety of this drug in these patients.
Determine the tolerance to this drug in these patients.
Determine the pharmacokinetics and pharmacodynamics of this drug and its metabolites in these patients.
Determine, preliminarily, any antineoplastic activity of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Schedule A: Patients receive R(+)XK469 IV over 30 minutes on days 1, 3, and 5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of R(+)XK469 until the recommended phase II dose or maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued and treated at the recommended phase II dose (for a maximum of 20 patients treated at that dose).

Schedule B: Once the recommended phase II dose is determined on schedule A, additional patients are accrued and receive escalating doses of R(+)XK469 IV over 30-60 minutes on day 1, beginning at a reduced dose. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Dose escalation continues as in schedule A.

PROJECTED ACCRUAL: Approximately 85 patients will be accrued for this study within 2.5-3.5 years.

Eligibility

Ages Eligible for Study:	5 Years to 20 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed high-risk neuroblastoma that has relapsed or is refractory to standard therapy
No active brain metastases
- Previously treated brain metastases allowed if there is no requirement for corticosteroids or anticonvulsants

PATIENT CHARACTERISTICS:

Age:

5 to 20 years old

Performance status:

Karnofsky performance status 70-100% or Lansky score ≥ 70 for your pediatric patients

Life expectancy:

More than 3 months

Hematopoietic:

WBC at least 3,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin normal (unless due to documented Gilbert's syndrome)

Renal:

Creatinine less than 1.5 times upper limit of normal

Cardiovascular:

No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia

Other:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other concurrent uncontrolled illness that would preclude study participation
No ongoing or active infection
No psychiatric illness or social situation that would preclude study participation
No prior allergic reaction to compounds of similar chemical or biological composition to study drug (e.g., flurbiprofen or ibuprofen)
No HIV-positive patients

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No concurrent biologic agents

Chemotherapy:

At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
No other concurrent chemotherapy

Endocrine therapy:

See Disease Characteristics

Radiotherapy:

At least 4 weeks since prior radiotherapy
No concurrent palliative radiotherapy

Surgery:

Not specified

Other:

See Disease Characteristics
Recovered from all prior therapy
No other concurrent investigational agents
No concurrent commercial agents or therapies directed at malignancy
No concurrent combination anti-retroviral therapy for HIV-positive patients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00028522

Locations

United States, Illinois
University of Chicago Cancer Research Center	Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424

Sponsors and Collaborators

University of Chicago

National Cancer Institute (NCI)

Investigators

Study Chair:

Susan L. Cohn, MD

University of Chicago Comer Children's Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000069101, UCCRC-11108B, NCI-4570
Study First Received:	January 4, 2002
Last Updated:	February 7, 2009
ClinicalTrials.gov Identifier:	NCT00028522 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

disseminated neuroblastoma
localized unresectable neuroblastoma
recurrent neuroblastoma
regional neuroblastoma

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors, Primitive, Peripheral
Neuroblastoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009