Clinical trial · Interventional
Methotrexate, Trimetrexate Glucuronate, and Leucovorin in Treating Patients With Refractory or Recurrent Osteosarcoma
Phase I Study of High Dose Methotrexate With Simultaneous Trimetrexate and Leucovorin in Patients With Recurrent Osteosarcoma
NCT00119301CI-TRIAL-00008963completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as methotrexate, trimetrexate glucuronate, and leucovorin, 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. PURPOSE: This phase I trial is studying the side effects and best dose of trimetrexate glucuronate when given together with methotrexate and leucovorin in treating patients with refractory or recurrent osteosarcoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| trimetrexate glucuronate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Maximum tolerated dose (MTD) after 1 course of treatment
- measure
- Dose-limiting toxicities as assessed by hematology and biochemistry testing on days 1, 8, and 28 of each course
Secondary outcomes (2)
- measure
- Antitumor activity as measured by radiographic response using RECIST criteria after every 2 courses of treatment
- measure
- Antitumor activity as measured by pathologic response using the Huvos grading system to evaluate post-treatment tumor necrosis at time of tumor resection after completion of study treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 35 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed malignant osteosarcoma * High-grade disease * Recurrent or refractory disease after prior standard chemotherapy comprising methotrexate, doxorubicin, cisplatin, and ifosfamide * No low-grade osteosarcoma * No parosteal or periosteal sarcoma * No osteosarcoma arising in premalignant bony lesions (e.g., Paget's disease) OR in a prior radiotherapy field * No symptomatic or known brain or leptomeningeal involvement PATIENT CHARACTERISTICS: Age * 1 to 35 Performance status * Karnofsky 70-100% (for patients \> 16 years of age) * Lansky 70-100% (for patients ≤ 16 years of age) Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 75,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times normal * AST and ALT ≤ 5 times normal * Albumin ≥ 2 g/dL * No clinically significant liver disease Renal * Creatinine ≤ 1.5 times normal OR * Creatinine clearance or radioisotope glomerular filtration rate ≥ lower limit of normal Cardiovascular * Shortening fraction ≥ 27% by echocardiogram OR * Ejection fraction ≥ 50% by gated radionuclide study * No congestive heart failure * No angina pectoris * No myocardial infarction within the past year * No uncontrolled arterial hypertension * No uncontrolled arrhythmias Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of significant neurological or psychiatric disorder * No active infection * No symptomatic peripheral neuropathy ≥ grade 2 * No other serious illness or medical condition PRIOR CONCURRENT THERAPY: Biologic therapy * At least 7 days since prior biologic therapy * At least 6 months since prior allogeneic stem cell transplantation AND no evidence of active graft-versus-host disease * No concurrent sargramostim (GM-CSF) Chemotherapy * See Disease Characteristics * More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 2 weeks since prior local palliative radiotherapy (small port) * At least 6 months since prior craniospinal radiotherapy * At least 6 months since prior radiotherapy to ≥ 50% of the pelvis * At least 6 weeks since prior substantial radiotherapy to the bone marrow Surgery * Not specified Other * Recovered from prior therapy * More than 30 days since prior and no other concurrent investigational drugs * More than 30 days since prior and no concurrent participation in another clinical trial * No concurrent medications that may interact with study drugs
References
Publications (0)
Data not yet available
No reference posted for this study.