Clinical trial · Interventional
Talotrexin in Treating Young Patients With Recurrent Solid Tumors or Leukemia That is Recurrent or Does Not Respond to Treatment
A Phase I Study Of Talotrexin (PT-523) In Children And Adolescents With Recurrent Solid Tumors Or Recurrent/Refractory Leukemias
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study withdrawn because of toxicity reported on the adult phase 1 trial.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy | Procedure | — | UNRESOLVED |
| talotrexin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Maximum tolerated dose of talotrexin
- measure
- Toxicity
Secondary outcomes (2)
- measure
- Antitumor activity
- measure
- Tolerability
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
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 years)
* No greater than 1.0 mg/dL (6 to 9 years)
* No greater than 1.2 mg/dL (10 to 12 years)
* No greater than 1.4 mg/dL (13 years and over \[female\])
* No greater than 1.5 mg/dL (13 to 15 years \[male\])
* No greater than 1.7 mg/dL (16 years and over \[male\])
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT ≤ 110 U/L (ULN is 45 U/L)
* Albumin ≥ 2 g/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No uncontrolled infection
* No known condition that, in the opinion of the investigator, would preclude study compliance
PRIOR CONCURRENT THERAPY:
* Recovered from all prior treatment-related toxicity
* At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) (for patients with solid tumors)
* At least 24 hours since prior cytoreduction therapy initiated with hydroxyurea (for patients with leukemia)
* At least 2 weeks since prior local palliative radiotherapy (small port)
* At least 6 months since prior total-body irradiation (TBI), craniospinal radiotherapy, or ≥ 50% radiotherapy to the pelvis
* At least 6 weeks since prior substantial bone marrow radiotherapy
* At least 3 months since prior stem cell transplant or rescue without TBI
* No evidence of active graft-versus-host disease
* At least 7 days since prior growth factor therapy
* At least 7 days since prior biological therapy
* No nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin or other salicylates, penicillins, sulfa drugs (bactrim, septra), ciprofloxacin, tetracycline, thiazide diuretics, or probenecid within 2 days prior to, during, or within 5 days after treatment with talotrexin
* No long-acting NSAIDs (e.g., nabumetone, naproxen, oxaprozin, piroxicam) within 5 days prior to, during, or within 5 days after treatment with talotrexin
* No concurrent investigational drugs
* No concurrent anticancer agents or therapy (e.g., chemotherapy, radiotherapy, immunotherapy, or biologic therapy)References
Publications (0)
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