Combination Chemotherapy in Treating Young Patients With Advanced Solid Tumors

NCT00281944 | Completed Phase 1

• 6 other identifiers: NCI-2009-0105104-0336MSKCC-040336CDR0000454709NCI-6952POETIC-COMIRB-040336
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial is studying the side effects and best dose of oxaliplatin when given together with leucovorin and fluorouracil in treating young patients with advanced solid tumors. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Conditions

Childhood Central Nervous System Choriocarcinoma; Childhood Central Nervous System Embryonal Tumor; Childhood Central Nervous System Germ Cell Tumor; Childhood Central Nervous System Germinoma; Childhood Central Nervous System Mixed Germ Cell Tumor; Childhood Central Nervous System Teratoma; Childhood Central Nervous System Yolk Sac Tumor; Recurrent Childhood Brain Stem Glioma; Recurrent Childhood Central Nervous System Embryonal Tumor; Unspecified Childhood Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (2)

• MTD based on the incidence of DLT as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 3.0

  14 days

• DLT defined as any grade 3 or greater non-hematologic toxicity attributed to the combination of drugs in this regimen, despite maximal supportive care as assessed by NCI CTCAE v. 3

  14 days

Secondary Outcomes (2)

• Safety profile as assessed by NCI CTCAE v. 3.0

  14 days

• Tumor response based on PET or PET/CT scan

  From baseline to 6 weeks

Study Arms (1)

Treatment (oxaliplatin, leucovorin calcium, fluorouracil)

EXPERIMENTAL

Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Drug: oxaliplatin; Drug: fluorouracil; Drug: leucovorin calcium; Other: pharmacological study; Procedure: positron emission tomography; Procedure: computed tomography

Interventions

oxaliplatin DRUG

Given IV

Also known as: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP

Treatment (oxaliplatin, leucovorin calcium, fluorouracil)

fluorouracil DRUG

Given IV

Also known as: 5-fluorouracil, 5-Fluracil, 5-FU

Treatment (oxaliplatin, leucovorin calcium, fluorouracil)

leucovorin calcium DRUG

Given IV

Also known as: CF, CFR, LV

Treatment (oxaliplatin, leucovorin calcium, fluorouracil)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (oxaliplatin, leucovorin calcium, fluorouracil)

positron emission tomography PROCEDURE

Undergo PET scan

Also known as: FDG-PET, PET, PET scan, tomography, emission computed

Treatment (oxaliplatin, leucovorin calcium, fluorouracil)

computed tomography PROCEDURE

Undergo PET/CT scan

Also known as: tomography, computed

Treatment (oxaliplatin, leucovorin calcium, fluorouracil)

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Histologically diagnosed malignant solid tumor, including tumors of the CNS, that has progressed despite standard therapy or for which no effective standard therapy is known
• Patients with brainstem glioma or intrinsic pontine glioma do not need biopsy proof of the diagnosis if imaging studies are consistent with the diagnosis
• Measurable or nonmeasurable disease
• No pleural effusion or ascites causing respiratory compromise (≥ grade 2 dyspnea)
• ECOG performance status (PS) 0-2 for patients ≥ 16 years of age
• Karnofsky PS ≥ 40% for patients \> 10 years of age
• Lansky Play Scale ≥ 40% for patients ≤ 10 years of age
• Peripheral absolute neutrophil count (ANC) ≥ 1,000/mm\^3
• Platelet count ≥ 75,000/mm\^3 (transfusion independent)
• Hemoglobin ≥ 8.5 g/dL (transfusion permitted)
• Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
• Creatinine clearance OR radioisotope glomerular filtration rate \> 60mL/min
• Total bilirubin \< 1.5 mg/dL
• ALT and AST ≤ 2.5 times ULN (5 times ULN if liver involvement with primary tumor)
• Ejection fraction ≥ 50% OR shortening fraction ≥ 28%

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Interventions

Oxaliplatin; Fluorouracil; Leucovorin; Magnetic Resonance Spectroscopy; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Lia Gore

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2006
• First Posted: January 25, 2006
• Study Start: September 1, 2005
• Primary Completion: May 1, 2009
• Last Updated: May 3, 2013

Record last verified: 2013-05

Locations

US (1)