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| ID | Type | Description | Link |
|---|---|---|---|
| ADVL0421 | |||
| COG-ADVL0421 | |||
| CDR0000384560 | |||
| U10CA098543 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxaliplatin | Drug | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | Response rate and confidence intervals will be constructed according to the method of Chang and O'Brien. | Up to 3 years |
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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:
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:
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 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
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| Name | Affiliation | Role |
|---|---|---|
| Orren Beaty | Children's Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Oncology Group | Arcadia | California | 91006-3776 | United States |
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| ID | Term |
|---|---|
| D018197 | Hepatoblastoma |
| D001254 | Astrocytoma |
| C562841 | Ovarian Germ Cell Cancer |
| D013736 | Testicular Neoplasms |
| D013724 | Teratoma |
| D018268 | Adrenocortical Carcinoma |
| C531673 | Familial ependymoma |
| D020339 | Optic Nerve Glioma |
| D003110 | Colonic Neoplasms |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D009303 | Nasopharyngeal Neoplasms |
| D009447 | Neuroblastoma |
| D012516 | Osteosarcoma |
| D012004 | Rectal Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D000306 | Adrenal Cortex Neoplasms |
| D000310 | Adrenal Gland Neoplasms |
| D000303 | Adrenal Cortex Diseases |
| D000307 | Adrenal Gland Diseases |
| D019574 | Optic Nerve Neoplasms |
| D003390 | Cranial Nerve Neoplasms |
| D009423 | Nervous System Neoplasms |
| D010524 | Peripheral Nervous System Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D009901 | Optic Nerve Diseases |
| D005128 | Eye Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D018242 | Neuroectodermal Tumors, Primitive |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D012509 | Sarcoma |
| D012002 | Rectal Diseases |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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