Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia, Osteosarcoma, or Non-Hodgkin's Lymphoma
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Completed | 21 and under at diagnosis | Other | MSKCC-95093 NCI-V96-0840, NCT00002738 |
Objectives
- Determine the efficacy of trimetrexate glucuronate with leucovorin calcium rescue in children with recurrent acute lymphoblastic leukemia, recurrent osteogenic sarcoma, or refractory non-Hodgkin's lymphoma resistant to methotrexate.
- Evaluate the toxicity of this treatment regimen in this patient population.
Entry Criteria
Disease Characteristics:
- Histologic evidence of one of the following malignancies that has failed conventional therapy:
- Acute lymphoblastic leukemia
- Non-Hodgkin's lymphoma with bone marrow involvement
- Osteogenic sarcoma
- In vitro transport resistance to methotrexate demonstrated by bone marrow aspirate assay
Prior/Concurrent Therapy:
Biologic therapy:
- Prior bone marrow transplantation allowed
Chemotherapy:
- At least 1 week since prior intrathecal treatment
- At least 2 weeks since prior systemic chemotherapy and
recovered
- At least 10 days for rapidly proliferating leukemia (i.e., WBC greater than 50,000)
- No concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Prior radiotherapy allowed and recovered
- No concurrent radiotherapy
Surgery:
- Not specified
Patient Characteristics:
Age:
- 21 and under at diagnosis
Performance status:
- ECOG 0-2
Life expectancy:
- At least 8 weeks
Hematopoietic:
- Granulocytopenia allowed with bone marrow involvement
- Thrombocytopenia allowed with bone marrow involvement
- Anemia allowed with bone marrow involvement
Hepatic:
- (unless due to disease)
- Bilirubin no greater than 2.0 mg/dL
- AST no greater than 100
Renal:
Other:
- No other serious medical illness
- Not pregnant or nursing
- Fertile patients must use effective contraception
Expected Enrollment
25A total of 25 patients will be accrued for this study within 2 years.
Outline
Patients are stratified according to disease (acute lymphocytic leukemia, non-Hodgkin's lymphoma vs osteogenic sarcoma).
Patients receive trimetrexate glucuronate orally or IV every 12 hours on days 1-21 and oral leucovorin calcium every 12 hours on days 1-24. Treatment repeats every 4 weeks. Patients with stable or responsive disease may receive up to 4 courses of therapy.
Trial Lead Organizations
Memorial Sloan-Kettering Cancer Center
 | | | |
| Tanya Trippett, MD, Protocol chair | |
| |
| |||
| Registry Information | ||
| ||
| Official Title | Phase II Trial of Trimetrexate and Leucovorin in The Treatment of Recurrent Childhood Acute Lymphoblastic Leukemia | |
| ||
| Trial Start Date | 1996-01-23 | |
| ||
| Trial Completion Date | 2006-06-13 | |
| ||
| Registered in ClinicalTrials.gov | NCT00002738 | |
| ||
| Date Submitted to PDQ | 1996-01-23 | |
| ||
| Information Last Verified | 2009-12-11 | |
| ||
| NCI Grant/Contract Number | P30-CA08748 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
Back to Top
