Recurrent Childhood Acute Lymphoblastic Leukemia Clinical Trial
Official title:
A Phase I Trial of Tomudex in Children With Leukemia
Phase I trial to study the effectiveness of raltitrexed in treating children with refractory acute leukemia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Status | Completed |
Enrollment | 30 |
Est. completion date | |
Est. primary completion date | June 2002 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 21 Years |
Eligibility |
Inclusion Criteria: - Histologically or cytologically proven acute leukemia (M3 marrow) that is refractory to conventional therapy or for which no effective therapy exists - No CNS leukemia - No solid tumors - Performance status: Karnofsky 50-100% OR Lansky at least 50 (for infants) - Life expectancy: At least 8 weeks - Bilirubin less than 1.5 mg/dL - SGPT less than 5 times normal - Normal creatinine for age OR GFR at least 70 mL/min - No significant systemic illness such as infection - No significant third space fluid collection - Not pregnant or nursing - Recovered from acute toxic effects of prior immunotherapy - At least 6 months since prior bone marrow transplant with no evidence of graft-versus-host disease - At least 10 days since prior biologic therapy - At least 1 week since prior growth factors - At least 2 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) and recovered - No concurrent steroids - Recovered from acute toxic effects of all prior radiotherapy - At least 2 weeks since prior local palliative radiotherapy (small port) - At least 6 months since prior substantial bone marrow radiation - No other concurrent anticancer therapy or investigational agents - No concurrent nonsteroidal anti-inflammatory agents |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | Swiss Pediatric Oncology Group - Geneva | Geneva |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MTD based on incidence of DLT graded according to CTC version 2.0 | Up to 4 weeks | No |
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