A Phase 2 Single-Arm Study of Gemcitabine in Combination with Oxaliplatin in Pediatric Patients with Relapsed or Refractory Neuroblastoma or Miscellaneous Solid Non-CNS Tumors

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

Patients are eligible to be included in the study only if they meet all of the following criteria:
[1] Histologically proven malignancy (at diagnosis): either neuroblastoma or other non-CNS solid tumors (excluding osteosarcoma).
[2] Measurable primary and/or metastatic disease:
For neuroblastoma measurable disease will be defined by the modified International Neuroblastoma Staging System and International Neuroblastoma Response Criteria (Brodeur et al. 1993).
For miscellaneous solid non-CNS tumors measurable disease will be defined by RECIST (Therasse et al. 2000).
[3] Relapsed or refractory tumors in which standard approaches to treatment have failed.
[4] No more than one salvage therapy for relapsed or refractory disease.
[5] 6 months to <18 years of age.
[6] Lansky play score ?70%, or Eastern Cooperative Oncology Group (ECOG) performance status ?1 (where more appropriate).
[7] Life expectancy ?3 months.
[8] Adequate organ function including the following:

Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ?1.0 ? 109/L, platelets ?100 ? 109/L (in case of bone marrow disease: ?75 ? 109/L), and hemoglobin ?8.0g/dL.

Hepatic: bilirubin ?1.5 times the upper limit of normal (? ULN), aspartate transaminase (AST) and alanine transaminase (ALT) ?2.5 ? ULN (AST, and ALT ?5 ? ULN is acceptable if liver has tumor involvement).

Renal: serum creatinine ?1.5 ? ULN for age, according to local lab value. If serum creatinine >1.5 ? ULN for age, then creatinine clearance (or radioisotope GFR) must be >70 ml/min/1.73 m2.
[9] Must have had their last dose of chemotherapy at least 3 weeks prior to study enrollment (first dose of study treatment); 2 weeks if the prior chemotherapy was single-agent vincristine; 6 weeks if the prior chemotherapy contained nitrosoureas.

Must have had their last dose of radiotherapy at least 4 weeks prior to study enrollment (first dose of study treatment);

Patients must have recovered from the acute toxic effects of all prior therapy before enrollment into the study.

[10] Able to comply with scheduled follow up and with management of toxicity.
[11] All patients with reproductive potential must practice an effective method of birth control while on study. Female patients with childbearing potential must have a negative pregnancy test within 7 days before study treatment.
[12] Written informed consent from patients or from parents or legal guardians for minor patients, according to local law and regulations.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded from the study if they meet any of the following criteria:
[13] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
[14] Concurrent administration of any other antitumor therapy.
[15] Have previously completed or withdrawn from this study or any other study investigating gemcitabine or oxaliplatin.
[16] Have a serious concomitant systemic disorder (for example, active infection including HIV, or cardiac disease) that, in the opinion of the investigator, would compromise the patient’s ability to complete the study.
[17] Have symptomatic brain metastases.
[18] re-existing sensory or motor neuropathy >Grade 2 (excluding neuropathy due to disease).
[19] History of allergic reaction to platinum compounds.
[20] Are pregnant or breastfeeding.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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Eli Lilly and Company Limited

Updated 3/19/2012