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

Primary Purpose

Childhood Central Nervous System Germ Cell Tumor, Childhood Extragonadal Germ Cell Tumor, Childhood Hepatoblastoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
oxaliplatin
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Central Nervous System Germ Cell Tumor

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Children's Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 7, 2004
Last Updated
June 4, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00091182
Brief Title
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

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Other Intervention Name(s)
1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Response rate
Description
Response rate and confidence intervals will be constructed according to the method of Chang and O'Brien.
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orren Beaty
Organizational Affiliation
Children's Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Oncology Group
City
Arcadia
State/Province
California
ZIP/Postal Code
91006-3776
Country
United States

12. IPD Sharing Statement

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

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