Talotrexin in Treating Young Patients With Recurrent Solid Tumors or Leukemia That is Recurrent o… (NCT00458744) | Clinical Trial Compass
WithdrawnPhase 1
Talotrexin in Treating Young Patients With Recurrent Solid Tumors or Leukemia That is Recurrent or Does Not Respond to Treatment
Stopped: Study withdrawn because of toxicity reported on the adult phase 1 trial.
0Started 2007-02
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as talotrexin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of talotrexin in treating young patients with recurrent solid tumors or leukemia that is recurrent or does not respond to treatment.
Who can participate
Age range1 Year – 21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Diagnosis of either of the following:
* Recurrent solid tumor
* Histologically confirmed\* malignancy at original diagnosis or relapse
* Measurable or evaluable disease
* Lymphoma or primary CNS tumor allowed
* Patients with CNS tumors must be on a stable or decreasing dose of dexamethasone for the past 7 days
* Recurrent or refractory leukemia
* Confirmed relapse, as defined by M3 marrow (25% blasts in bone marrow aspirate or biopsy)
* Active extramedullary disease allowed provided there is no leptomeningeal involvement NOTE: \*Histological confirmation not required for intrinsic brain stem tumors
* Bone marrow metastases allowed
* Not refractory to red blood cell or platelet transfusion
* No pleural effusion or significant ascites
* No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists
* No Down syndrome
PATIENT CHARACTERISTICS:
* Karnofsky performance status (PS) 50-100% (for patients \> 10 years of age) OR Lansky PS 50-100% (for patients ≤ 10 years of age)
* Absolute neutrophil count ≥ 1,000/mm³ (for patients with solid tumors without bone marrow involvement)
* Platelet count ≥ 100,000/mm³ (transfusion independent)
* Hemoglobin ≥ 8.0 g/dL
* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine adjusted according to age as follows:
* No greater than 0.6 mg/dL (1 year to 23 months)
* No greater than 0.8 mg/dL (2 to 5…