Oxaliplatin in Treating Young Patients With Recurrent Solid Tumors That Have Not Responded to Previous Treatment - Full Text View

Purpose

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.

Condition	Intervention	Phase
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	Drug: oxaliplatin	Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Oxaliplatin in Children With Recurrent Solid Tumors

Resource links provided by NLM:

Genetics Home Reference related topics: Ewing sarcoma neuroblastoma

MedlinePlus related topics: Cancer

Drug Information available for: Oxaliplatin

Genetic and Rare Diseases Information Center resources: Adrenocortical Carcinoma Anaplastic Astrocytoma Bone Cancer Brain Stem Glioma, Childhood Cerebellar Astrocytoma, Childhood Cerebral Astrocytoma, Childhood Ependymoma Ewing's Family of Tumors Ewing's Sarcoma Extragonadal Germ Cell Tumor Glioma Gliosarcoma Hepatoblastoma Hepatocellular Carcinoma, Childhood Kidney Cancer Liver Cancer Malignant Germ Cell Tumor Malignant Mesenchymal Tumor Nasopharyngeal Carcinoma Neural Crest Tumor Neuroblastoma Neuroepithelioma Osteosarcoma Ovarian Cancer Ovarian Germ Cell Tumor Renal Cancer Soft Tissue Sarcoma Testicular Cancer

U.S. FDA Resources

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

Primary Outcome Measures:

Response rate [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Response rate and confidence intervals will be constructed according to the method of Chang and O'Brien.


Enrollment:	180
Study Start Date:	October 2004
Primary Completion Date:	February 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I 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.	Drug: oxaliplatin Given IV Other Names: 1-OHP Dacotin Dacplat Eloxatin L-OHP

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


Ages Eligible for Study:	up to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091182

Locations


United States, California
Children's Oncology Group
Arcadia, California, United States, 91006-3776

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Orren Beaty	Children's Oncology Group

More Information

No publications provided


Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00091182 History of Changes
Other Study ID Numbers:	NCI-2012-01815, ADVL0421, COG-ADVL0421, CDR0000384560, U10CA098543
Study First Received:	September 7, 2004
Last Updated:	June 4, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Adrenocortical Carcinoma Astrocytoma Carcinoma Carcinoma, Hepatocellular Gliosarcoma Hepatoblastoma Liver Neoplasms Neoplasms, Germ Cell and Embryonal Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Optic Nerve Glioma Ovarian Neoplasms Testicular Neoplasms Adenocarcinoma	Adnexal Diseases Adrenal Cortex Diseases Adrenal Cortex Neoplasms Adrenal Gland Diseases Adrenal Gland Neoplasms Cranial Nerve Diseases Cranial Nerve Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Eye Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female

ClinicalTrials.gov processed this record on March 03, 2015