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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00091182

Collaborator

(none)

180

Enrollment

Location

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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

Detailed Description

OBJECTIVES:

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

Study Design

Study Type:

Interventional

Actual Enrollment :

180 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2004

Actual Primary Completion Date :

Feb 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Response rate [Up to 3 years]
Response rate and confidence intervals will be constructed according to the method of Chang and O'Brien.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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