High-Dose Methotrexate in Treating Young Patients With Solid Tumors

NCT00513981 | Completed Phase 1

• 4 other identifiers: CCLG-NAG-2005-13CDR0000560133EU-20744EUDRACT-2005-001757-13
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 21

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as high-dose methotrexate work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as leucovorin calcium, may protect normal cells from the side effects of chemotherapy. PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of high-dose methotrexate in treating patients with solid tumors.

Conditions

Brain and Central Nervous System Tumors; Sarcoma; Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

unspecified childhood solid tumor, protocol specific; recurrent osteosarcoma; recurrent childhood soft tissue sarcoma; recurrent childhood ependymoma; untreated childhood brain stem glioma; recurrent childhood brain stem glioma

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated infusion time for high-dose methotrexate

Secondary Outcomes (1)

• Plasma biochemical evidence of the systemic effect of methotrexate in terms of changes in plasma homocysteine and methionine

Interventions

leucovorin calcium DRUG

methotrexate DRUG

mass spectrometry OTHER

pharmacological study OTHER

Eligibility Criteria

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

You may qualify if:

• Lansky performance status (PS) 30-100% (for patients ≤ 12 years of age)
• ECOG PS ≤ 2 (for patients ≥ 13 years of age)
• Life expectancy ≥ 9 weeks
• ANC \> 1,000/mm³
• Platelet count \> 100,000/mm³
• Hemoglobin \> 9 g/dL
• Serum creatinine ≤ 1.5 times upper limit of normal (ULN) for age
• Serum total bilirubin normal
• AST or ALT ≤ 2 times ULN
• Glomerular filtration rate ≥ 60 mL/min
• Negative pregnancy test
• Fertile patients must use effective contraception

You may not qualify if:

• Poor medical risk because of nonmalignant systemic disease or uncontrolled infection
• Concurrent malignancies at other sites
• PRIOR CONCURRENT THERAPY:
• Prophylactic trimethoprim-sulfamethoxazole must be stopped 1 week prior to methotrexate administration
• Received chemotherapy or biologic therapy within the past 4 weeks
• Received radiotherapy within the past 6 weeks

Sponsors & Collaborators

• Children's Cancer and Leukaemia Group: lead

Study Sites (21)

Our Lady's Hospital for Sick Children Crumlin

Dublin, 12, Ireland

Location

Birmingham Children's Hospital

Birmingham, England, B4 6NH, United Kingdom

Location

Bristol Royal Hospital for Children

Bristol, England, BS2 8BJ, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, L12 2AP, United Kingdom

Location

University College Hospital

London, England, NW1 2PCE, United Kingdom

Location

Great Ormond Street Hospital for Children

London, England, WC1N 3JH, United Kingdom

Location

Royal Manchester Children's Hospital

Manchester, England, M27 4HA, United Kingdom

Location

Sir James Spence Institute of Child Health

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

Location

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

Location

Children's Hospital - Sheffield

Sheffield, England, S10 2TH, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, BT12 6BE, United Kingdom

Location

Royal Aberdeen Children's Hospital

Aberdeen, Scotland, AB25 2ZG, United Kingdom

Location

Royal Hospital for Sick Children

Edinburgh, Scotland, EH9 1LF, United Kingdom

Location

Royal Hospital for Sick Children

Glasgow, Scotland, G3 8SJ, United Kingdom

Location

Childrens Hospital for Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Sarcoma; Osteosarcoma; Familial ependymoma

Interventions

Leucovorin; Methotrexate; Mass Spectrometry

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Aminopterin; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Eddy J. Estlin

  Royal Manchester Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 8, 2007
• First Posted: August 9, 2007
• Study Start: March 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: August 1, 2009
• Last Updated: June 26, 2013

Record last verified: 2009-06

Locations

IE (1); GB (20)