Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia, Osteosarcoma, or Non-Hodgkin's Lymphoma
Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Jan 26, 2003
Trial Information
Current as of June 23, 2025
Completed
Keywords
ClinConnect Summary
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.
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....
Gender
ALL
Eligibility 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
- 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:
- • Creatinine less than 1.5 mg/dL OR
- • Creatinine clearance at least 60 mL/min
- Other:
- • No other serious medical illness
- • Not pregnant or nursing
- • Fertile patients must use effective contraception
- 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
About Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center (MSKCC) is a world-renowned institution dedicated to cancer treatment, research, and education. As a leading clinical trial sponsor, MSKCC focuses on advancing innovative cancer therapies through rigorous scientific investigation and collaboration. The center's multidisciplinary team of experts employs cutting-edge methodologies to design and conduct trials that aim to improve patient outcomes and enhance understanding of cancer biology. With a commitment to translating research findings into clinical practice, MSKCC plays a pivotal role in shaping the future of oncology care and ensuring that patients have access to the latest therapeutic advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
Patients applied
Trial Officials
Tanya Trippett, MD
Study Chair
Memorial Sloan Kettering Cancer Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials