Oxaliplatin, Ifosfamide and Etoposide in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma

• Register: ClinicalTrials.gov
• Last refreshed on: 14 January 2013
• Main ID: NCT00101205
• Date of registration: 07/01/2005
• Primary sponsor: National Cancer Institute (NCI)
• Public title: Oxaliplatin, Ifosfamide and Etoposide in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma
• Scientific title: 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
• Date of first enrolment: November 2004
• Target sample size: 40
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00101205
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Lisa McGregor
• Affiliation: St. Jude Children's Research Hospital

Key inclusion & exclusion criteria

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.



Age minimum: N/A
Age maximum: 21 Years
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Drug: etoposide

Drug: oxaliplatin

Primary Outcome(s)

MTD of the addition of ifosfamide to the combination of oxaliplatin and etoposide assessed by CTCAE version 3.0 [Time Frame: 21 days]

MTD of the combination of oxaliplatin and etoposide assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [Time Frame: 21 days]

Secondary ID(s)

CDR0000405828

NCI-2009-00075

OXALET

Source(s) of Monetary Support

Please refer to primary and secondary sponsors