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Phase I Study Of R(+)XK469 In Patients With Advanced Neuroblastoma


Phase 1
5 Years
20 Years
Not Enrolling
Both
Disseminated Neuroblastoma, Localized Unresectable Neuroblastoma, Recurrent Neuroblastoma, Regional Neuroblastoma

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Trial Information

Phase I Study Of R(+)XK469 In Patients With Advanced Neuroblastoma


OBJECTIVES:

I. 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.

II. Determine the safety of this drug in these patients. III. Determine the tolerance to
this drug in these patients. IV. Determine the pharmacokinetics and pharmacodynamics of this
drug and its metabolites in these patients.

V. Determine, preliminarily, any antineoplastic activity of this drug in these patients.

OUTLINE: This is a dose-escalation study.

SCHEDULE A: Patients receive R(+)XK469 intravenously (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.


Inclusion Criteria:



- 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

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

- More than 3 months

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

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

- Creatinine less than 1.5 times upper limit of normal

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- 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

- No concurrent biologic agents

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)

- No other concurrent chemotherapy

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy

- No concurrent palliative radiotherapy

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of XK469 in pediatric patients with advanced neuroblastoma

Outcome Description:

Defined as the highest dose studied for which the incidence of dose-limiting toxicity (DLT) was less than 33%.

Outcome Time Frame:

Day 29 of course 1

Safety Issue:

Yes

Principal Investigator

Susan Cohn

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00013

NCT ID:

NCT00028522

Start Date:

December 2001

Completion Date:

Related Keywords:

  • Disseminated Neuroblastoma
  • Localized Unresectable Neuroblastoma
  • Recurrent Neuroblastoma
  • Regional Neuroblastoma
  • Neuroblastoma

Name

Location

University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470