Status:
COMPLETED
Methotrexate, Trimetrexate Glucuronate, and Leucovorin in Treating Patients With Refractory or Recurrent Osteosarcoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Sarcoma
Eligibility:
All Genders
1-35 years
Phase:
PHASE1
Brief Summary
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 stopp...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of trimetrexate glucuronate when administered with high-dose methotrexate and leucovorin calcium in patients with refractory or recurrent h...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00119301
Start Date
April 1 2005
Last Update
January 17 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021