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A Phase I Trial of the Combination of Oxaliplatin (NSC 266046, IND 57004), Ifosfamide, and Etoposide in Recurrent or Refractory Pediatric Solid Tumors and Lymphomas


Phase 1
N/A
21 Years
Not Enrolling
Both
Childhood Burkitt Lymphoma, Childhood Central Nervous System Germ Cell Tumor, Childhood Diffuse Large Cell Lymphoma, Childhood Grade III Lymphomatoid Granulomatosis, Childhood Immunoblastic Large Cell Lymphoma, Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Ependymoma, Recurrent Childhood Grade III Lymphomatoid Granulomatosis, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Liver Cancer, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Malignant Germ Cell Tumor, Recurrent Childhood Medulloblastoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor, Recurrent Childhood Visual Pathway Glioma, Recurrent Colon Cancer, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Melanoma, Recurrent Nasopharyngeal Cancer, Recurrent Neuroblastoma, Recurrent Osteosarcoma, Recurrent Wilms Tumor and Other Childhood Kidney Tumors, Recurrent/Refractory Childhood Hodgkin Lymphoma, Unspecified Childhood Solid Tumor, Protocol Specific

Thank you

Trial Information

A Phase I Trial of the Combination of Oxaliplatin (NSC 266046, IND 57004), Ifosfamide, and Etoposide in Recurrent or Refractory Pediatric Solid Tumors and Lymphomas


PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose of oxaliplatin and etoposide in pediatric patients
with recurrent or refractory solid tumors or lymphoma.

II. Determine the dose-limiting toxic effects of this regimen in these patients.

SECONDARY OBJECTIVES:

I. Determine the pharmacokinetic profile of this regimen in these patients. II. Correlate
the extent of oxaliplatin and etoposide exposure with toxic effects and therapeutic effects
of this regimen in these patients.

III. Determine, preliminarily, the antitumor activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive oxaliplatin IV over 2 hours on day 1 and etoposide IV over 1 hour on days
1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable
toxicity.

Cohorts of 3-6 patients receive escalating doses of oxaliplatin and etoposide 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.


Inclusion Criteria:



- Life expectancy > 8 weeks

- Albumin > 2 g/dL

- Histologically confirmed diagnosis of 1 of the following: solid tumor; histologic
verification not required for brainstem tumors or optic pathway tumors; lymphoma;
recurrent or refractory to conventional therapy OR no known effective therapy exists;
bone marrow involvement allowed

- Performance Status: Karnofsky >= 50 % (patients > 10 years of age) OR Lansky >= 50%
(patients for =< 10 years of age)

- Absolute neutrophil count > 1,000/mm^3

- Platelet count > 100,000/mm^3 (transfusion independent)

- Hemoglobin > 8 g/dL (transfusion allowed)

- ALT < 5.0 times ULN

- Creatinine normal OR glomerular filtration rate >= 80 mL/min/1.73 m^2

- Calcium normal (electrolyte supplements allowed)

- Echocardiogram and EKG normal

- Shortening fraction >= 27% OR ejection fraction > 50%

- No evidence of dyspnea at rest

- No exercise intolerance

- Pulse oximetry > 94% on room air

- Neurologic deficits due to CNS tumor must be relatively stable for >= 2 weeks before
study entry

- Seizure disorder allowed provided well-controlled by non-enzyme-inducing
anticonvulsants

- No peripheral neurotoxicity > grade 1

- Sodium, potassium, and magnesium normal (electrolyte supplements allowed)

- At least 1 week since prior biologic agents

- More than 1 week since prior growth factors

- More than 6 months since prior allogeneic peripheral blood stem cell transplantation
AND no active graft-versus-host disease

- More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for
nitrosoureas)

- More than 2 weeks since prior focal radiotherapy for symptomatic metastatic sites

- More than 6 weeks since prior substantial bone marrow radiotherapy

- More than 3 months since prior craniospinal (> 24 Gy), whole pelvis, or total-body
radiotherapy

- Recovered from all prior therapy

- No concurrent enzyme-inducing anticonvulsants, including, but not limited to, the
following: Barbiturates; Phenytoin; Carbamazepine

Exclusion Criteria:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No uncontrolled infection

- No history of life-threatening hypersensitivity to platinum-containing agents

- No prior oxaliplatin

- No other concurrent investigational agents

- No other concurrent anticancer therapy

- Inability or unwillingness of research participant or legal guardian/representative
to give written informed consent.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MTD of the combination of oxaliplatin and etoposide assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

Outcome Time Frame:

21 days

Safety Issue:

Yes

Principal Investigator

Lisa McGregor

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00075

NCT ID:

NCT00101205

Start Date:

November 2004

Completion Date:

Related Keywords:

  • Childhood Burkitt Lymphoma
  • Childhood Central Nervous System Germ Cell Tumor
  • Childhood Diffuse Large Cell Lymphoma
  • Childhood Grade III Lymphomatoid Granulomatosis
  • Childhood Immunoblastic Large Cell Lymphoma
  • Recurrent Childhood Brain Stem Glioma
  • Recurrent Childhood Cerebellar Astrocytoma
  • Recurrent Childhood Cerebral Astrocytoma
  • Recurrent Childhood Ependymoma
  • Recurrent Childhood Grade III Lymphomatoid Granulomatosis
  • Recurrent Childhood Large Cell Lymphoma
  • Recurrent Childhood Liver Cancer
  • Recurrent Childhood Lymphoblastic Lymphoma
  • Recurrent Childhood Malignant Germ Cell Tumor
  • Recurrent Childhood Medulloblastoma
  • Recurrent Childhood Rhabdomyosarcoma
  • Recurrent Childhood Small Noncleaved Cell Lymphoma
  • Recurrent Childhood Soft Tissue Sarcoma
  • Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor
  • Recurrent Childhood Visual Pathway Glioma
  • Recurrent Colon Cancer
  • Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Recurrent Melanoma
  • Recurrent Nasopharyngeal Cancer
  • Recurrent Neuroblastoma
  • Recurrent Osteosarcoma
  • Recurrent Wilms Tumor and Other Childhood Kidney Tumors
  • Recurrent/Refractory Childhood Hodgkin Lymphoma
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • Astrocytoma
  • Burkitt Lymphoma
  • Colonic Neoplasms
  • Ependymoma
  • Glioma
  • Hodgkin Disease
  • Kidney Neoplasms
  • Liver Neoplasms
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphomatoid Granulomatosis
  • Medulloblastoma
  • Melanoma
  • Wilms Tumor
  • Neuroblastoma
  • Osteosarcoma
  • Rhabdomyosarcoma
  • Lymphoma, Large-Cell, Immunoblastic
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Nasopharyngeal Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive
  • Rhabdomyosarcoma, Embryonal
  • Sarcoma
  • Optic Nerve Glioma
  • Lymphoma, Extranodal NK-T-Cell
  • Neoplasms
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral

Name

Location
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794