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Stopped: Study withdrawn because of toxicity reported on the adult phase 1 trial.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 range
1 Year – 21 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.