- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00101270
Oxaliplatin and Irinotecan in Treating Young Patients With Refractory Solid Tumors or Lymphomas
A Phase I Study of Oxaliplatin (NSC# 266046, IND #57004) and Irinotecan in Pediatric Patients With Refractory Solid Tumors and Lymphomas
Study Overview
Status
Conditions
- Unspecified Childhood Solid Tumor, Protocol Specific
- Recurrent Childhood Medulloblastoma
- Recurrent Childhood Ependymoma
- Recurrent Melanoma
- Recurrent Neuroblastoma
- Recurrent Osteosarcoma
- Recurrent Childhood Rhabdomyosarcoma
- Recurrent Colon Cancer
- Recurrent Wilms Tumor and Other Childhood Kidney Tumors
- Recurrent Childhood Soft Tissue Sarcoma
- Childhood Diffuse Large Cell Lymphoma
- Childhood Grade III Lymphomatoid Granulomatosis
- Childhood Immunoblastic Large Cell Lymphoma
- Recurrent Childhood Grade III Lymphomatoid Granulomatosis
- Recurrent Childhood Large Cell Lymphoma
- Recurrent Childhood Lymphoblastic Lymphoma
- Recurrent Childhood Small Noncleaved Cell Lymphoma
- Recurrent/Refractory Childhood Hodgkin Lymphoma
- Childhood Burkitt Lymphoma
- Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
- Recurrent Childhood Malignant Germ Cell Tumor
- Recurrent Childhood Liver Cancer
- Recurrent Childhood Brain Stem Glioma
- Recurrent Childhood Cerebellar Astrocytoma
- Recurrent Childhood Cerebral Astrocytoma
- Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor
- Recurrent Childhood Visual Pathway Glioma
- Childhood Central Nervous System Germ Cell Tumor
- Recurrent Nasopharyngeal Cancer
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of oxaliplatin when administered with irinotecan in pediatric patients with refractory solid tumors or lymphomas.
II. Determine the toxic effects of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients.
SECONDARY OBJECTIVES:
I. Determine, preliminarily, the antitumor activity of this regimen in these patients.
II. Correlate UGT and BCRP genotype with the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter, dose-escalation study of oxaliplatin.
Patients receive oxaliplatin IV over 2 hours on days 1 and 8 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
California
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Arcadia, California, United States, 91006-3776
- COG Phase I Consortium
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Histologically confirmed refractory malignant solid tumor or lymphoma
- Intrinsic brain stem tumors and optic pathway tumors do not require histologic verification
- No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists
Measurable or evaluable disease
Evaluable disease is defined as a tumor that cannot be measured using a ruler or calipers, but can be assessed to determine disease progression or complete response, such as any of the following:
- Positive lesions on metaiodobenzylguanidine (MIBG) or bone scan
- Metastatic bone marrow disease
- Elevated tumor markers
- Presence of a malignant pleural effusion
- No leukemia
- Performance status - Karnofsky 50-100% (for patients > 10 years of age)
- Performance status - Lansky 50-100% (for patients ≤ 10 years of age)
- Not specified
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 100,000/mm^3 (transfusion independent)
- Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT ≤ 5 times ULN
- Albumin ≥ 2 g/dL
- Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min
Creatinine based on age as follows:
- No greater than 0.8 mg/dL (for patients age 5 and under)
- No greater than 1.0 mg/dL (for patients age 6 to 10)
- No greater than 1.2 mg/dL (for patients age 11 to 15)
- No greater than 1.5 mg/dL (for patients age 16 and over)
- No arrhythmia on EKG
- No evidence of dyspnea at rest
- No exercise intolerance
- Pulse oximetry > 94% on room air and no evidence of pulmonary fibrosis by chest radiograph* or CT scan
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- Weight ≥ 10 kg
- Neurologic deficits relatively stable for ≥ 1 week before study entry (patients with CNS tumors only)
- No electrolyte (e.g., sodium, potassium, bicarbonate, calcium, magnesium, and phosphate) abnormality ≥ grade 2 (electrolyte supplementation allowed)
- No uncontrolled infection
- No history of life-threatening allergy to camptothecin derivatives or platinum agents
- No sensory or motor peripheral neuropathy ≥ grade 2
- No elevation of amylase or lipase ≥ grade 2
- Able to tolerate enteral medications (e.g., cefixime, cefpodoxime, or loperamide)
- Recovered from all prior immunotherapy
- At least 7 days since prior hematopoietic growth factors
- At least 7 days since prior antineoplastic biologic therapy
- Prior stem cell transplantation or rescue without total-body irradiation (TBI) allowed provided ≥ 3 months have elapsed and there is no evidence of active graft-versus-host disease
- No concurrent immunotherapy
- No concurrent biologic therapy
- More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered
- No prior oxaliplatin
- No other concurrent chemotherapy
- Concurrent steroids allowed provided dose has been stable for ≥ 7 days before study entry
- See Biologic therapy
- Recovered from all prior radiotherapy
- At least 2 weeks since prior local palliative small port radiotherapy
- At least 6 months since prior TBI
- At least 6 months since prior craniospinal, whole spinal, or whole lung/abdominal 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
- No concurrent radiotherapy
- No other concurrent investigational drugs
- No other concurrent anticancer therapy
- No concurrent cephalosporin antibiotics
No concurrent use of any of the following:
- Phenytoin
- Carbamazepine
- Oxcarbazepine
- Barbiturates
- Rifampin
- Phenobarbital
- Azole antifungal agents
- Aprepitant
- Hypericum perforatum (St. John's wort)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (irinotecan hydrochloride, oxaliplatin)
Patients receive oxaliplatin IV over 2 hours on days 1 and 8 and irinotecan IV over 1 hour on days 1-5 and 8-12.
Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
|
Given IV
Other Names:
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MTD of oxaliplatin, defined as the maximum dose at which fewer than one-third of patients experience DLT
Time Frame: 21 days
|
Graded using the NCI CTCAE version 3.0.
|
21 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall response assessed using RECIST criteria
Time Frame: Up to 12 months
|
Up to 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lisa McGregor, COG Phase I Consortium
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Virus Diseases
- Infections
- Immune System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Genetic Diseases, Inborn
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Neoplasms, Neuroepithelial
- Neoplasms, Nerve Tissue
- Kidney Neoplasms
- DNA Virus Infections
- Tumor Virus Infections
- Neoplastic Syndromes, Hereditary
- Neoplasms, Complex and Mixed
- Precancerous Conditions
- Leukemia, Lymphoid
- Leukemia
- Epstein-Barr Virus Infections
- Herpesviridae Infections
- Neoplasms, Bone Tissue
- Neoplasms, Connective Tissue
- Lymphoma, B-Cell
- Neoplasms, Muscle Tissue
- Lymphoma, T-Cell
- Myosarcoma
- Neoplasms
- Sarcoma
- Lymphoma
- Lymphoma, Large B-Cell, Diffuse
- Neoplasms, Germ Cell and Embryonal
- Nasopharyngeal Carcinoma
- Nasopharyngeal Neoplasms
- Recurrence
- Lymphoma, Non-Hodgkin
- Glioma
- Burkitt Lymphoma
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Lymphoma, Large-Cell, Immunoblastic
- Plasmablastic Lymphoma
- Sarcoma, Ewing
- Ependymoma
- Medulloblastoma
- Osteosarcoma
- Astrocytoma
- Neuroblastoma
- Lymphomatoid Granulomatosis
- Lymphoma, Extranodal NK-T-Cell
- Rhabdomyosarcoma
- Neuroectodermal Tumors
- Neuroectodermal Tumors, Primitive
- Wilms Tumor
- Neuroectodermal Tumors, Primitive, Peripheral
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Oxaliplatin
- Irinotecan
Other Study ID Numbers
- NCI-2012-01819
- U01CA097452 (U.S. NIH Grant/Contract)
- ADVL0415
- CDR0000401518
- COG-ADVL0415
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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