Oxaliplatin in Treating Young Patients… | Clinical Trial

Key information

Conditions

Childhood Central Nervous System Germ Cell Tumor Adenocarcinoma Adrenal Cortex Diseases Adrenal Cortex Neoplasms Adrenal Gland Diseases Adrenal Gland Neoplasms Adrenocortical Carcinoma Astrocytoma Carcinoma Carcinoma, Renal Cell 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 Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Cranial Nerve Diseases Cranial Nerve Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Eye Diseases Familial ependymoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Glioma Gonadal Disorders Head and Neck Neoplasms Hepatoblastoma Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Bone Tissue Neoplasms, Complex and Mixed Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Optic Nerve Diseases Optic Nerve Glioma Optic Nerve Neoplasms Osteosarcoma Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Ovarian Germ Cell Cancer Peripheral Nervous System Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Rectal Diseases Rectal Neoplasms 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 Sarcoma Stomatognathic Diseases Teratoma Testicular Diseases Testicular Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Children's Oncology Group

Arcadia, California, 91006-3776, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxaliplatin

Drug

Given IV

Other names: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP

Primary outcomes

Response rate

Time frame: Up to 3 years

Response rate and confidence intervals will be constructed according to the method of Chang and O'Brien.

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

A Phase II Study of Oxaliplatin in Children With Recurrent Solid Tumors

Important dates

Study start: 2004
Primary completion: 2006
First posted: Sep 9, 2004
Registry last updated: Jun 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed