Clinical trial NCT00091182: Oxaliplatin in Treating Young Patients With Recurrent Solid Tumors That Have Not Responded to Previous Treatment
Official title: A Phase II Study of Oxaliplatin in Children With Recurrent Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Childhood Central Nervous System Germ Cell Tumor
Childhood Extragonadal Germ Cell Tumor
Childhood Hepatoblastoma
Childhood Hepatocellular Carcinoma
Childhood High-grade Cerebral Astrocytoma
Childhood Low-grade Cerebral Astrocytoma
Childhood Malignant Ovarian Germ Cell Tumor
Childhood Malignant Testicular Germ Cell Tumor
Childhood Teratoma
Recurrent Adrenocortical Carcinoma
Recurrent Childhood Brain Stem Glioma
Recurrent Childhood Cerebellar Astrocytoma
Recurrent Childhood Cerebral Astrocytoma
Recurrent Childhood Ependymoma
Recurrent Childhood Liver Cancer
Recurrent Childhood Malignant Germ Cell Tumor
Recurrent Childhood Rhabdomyosarcoma
Recurrent Childhood Soft Tissue Sarcoma
Recurrent Childhood Visual Pathway and Hypothalamic Glioma
Recurrent Colon Cancer
Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
Recurrent Nasopharyngeal Cancer
Recurrent Neuroblastoma
Recurrent Osteosarcoma
Recurrent Rectal Cancer
Recurrent Renal Cell Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-09-09
Enrollment: 180
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase II trial is studying how well oxaliplatin works in treating young patients with recurrent solid tumors that have not responded to previous treatment. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die.

Detailed description: OBJECTIVES:

I. Determine the response rate in children with recurrent or refractory solid tumors treated with oxaliplatin.

II. Determine the cumulative toxicity of this drug in these patients. III. Determine the pharmacokinetic profile of this drug in these patients. IV. Determine time to progression and overall survival of patients treated with this drug.

V. Correlate the extent of oxaliplatin exposure with response in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease type.

Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed\* solid tumor, including any of the following:

  * Ewing's sarcoma/peripheral primitive neuroectodermal tumor (PNET)
  * Osteosarcoma
  * Rhabdomyosarcoma
  * Neuroblastoma
  * High-grade astrocytoma
  * Low-grade astrocytoma
  * Glioblastoma multiforme
  * Ependymoma
  * Hepatoblastoma
  * Germ cell tumors of any site
  * Rare tumors of interest, including any of the following:

    * Soft tissue sarcoma
    * Hepatocellular carcinoma
    * Childhood/adolescent colorectal carcinoma
    * Childhood/adolescent renal cell carcinoma
    * Childhood/adolescent adrenocortical carcinoma
    * Childhood/adolescent nasopharyngeal carcinoma
* Recurrent disease OR refractory to conventional therapy
* Measurable disease by clinical exam, CT scan, MRI, or positron emission tomography
* Performance status - Karnofsky 50-100% (for patients over age 10)
* Performance status - Lansky 50-100% (for patients age 10 and under)
* At least 8 weeks
* Absolute neutrophil count ≥ 1,000/mm\^3\*
* Platelet count ≥ 75,000/mm\^3\* (transfusion independent)
* Hemoglobin ≥ 8.0 g/dL\* (RBC transfusions allowed)
* Granulocytopenia, anemia, and/or thrombocytopenia due to bone marrow metastases or extensive prior radiotherapy allowed provided the above hematological criteria are met
* Bilirubin ≤ 3 mg/dL
* Creatinine based on age as follows:

  * ≤ .8 mg/dL (for patients age 5 and under)
  * ≤ 1.0 mg/dL (for patients age 6 to 10)
  * ≤ 1.2 mg/dL (for patients age 11 to 15)
  * ≤1.5 mg/dL (for patients age 16 to 21)
* Creatinine clearance or radioisotope glomerular filtration rate \> 20 mL/min
* No uncontrolled seizure disorder
* No uncontrolled infection
* CNS toxicity ≤ grade 2
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Recovered from prior immunotherapy
* At least 7 days since prior anticancer biologic therapy
* More than 1 week since prior growth factors
* At least 6 months since prior allogeneic stem cell transplantation

  * No evidence of active graft-vs-host disease
* No concurrent immunomodulating agents
* Recovered from prior chemotherapy
* No prior oxaliplatin
* Prior carboplatin or cisplatin allowed
* More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
* No other concurrent anticancer chemotherapy
* Concurrent dexamethasone for CNS tumors allowed provided patient has been on a stable or decreasing dose for ≥ 1 week before study entry
* Recovered from prior radiotherapy
* At least 2 weeks since prior local palliative radiotherapy (small port)
* At least 6 months since prior craniospinal radiotherapy
* At least 6 months since prior radiotherapy to ≥ 50% of the pelvis
* At least 6 weeks since other prior substantial radiotherapy to the bone marrow
* Concurrent radiotherapy to localized painful lesions allowed provided ≥ 1 measurable lesion is not irradiated
* No other concurrent investigational agents
* No other concurrent anticancer agents

Primary outcomes:
measure: Response rate
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Arcadia
country: United States
facility: Children's Oncology Group
state: California
Study officials:
affiliation: Children's Oncology Group
name: Orren Beaty
role: PRINCIPAL_INVESTIGATOR
References: