Clinical trial · Interventional
Talotrexin in Treating Patients With Advanced or Recurrent Solid Tumors
A Phase I Study Of PT523 In Patients With Solid Tumors
NCT00098514CI-TRIAL-00030826completedPhase 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 talotrexin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying side effects, best way to give, and best dose of talotrexin in treating patients with advanced or recurrent solid tumors.
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 |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| talotrexin ammonium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Dose Level 1a
- description
- 10 mg/m2 dose of PT523 administered day 1 of a 28-day cycle as a 5 minute IV infusion (IV bolus)
- interventionNames
- Drug: talotrexin ammonium
- type
- EXPERIMENTAL
- label
- Dose Level 1b
- description
- 5 mg/m2 dose of PT523 administered days 1 and 8 of a 28-day cycle as a 5 minute IV infusion
- interventionNames
- Drug: talotrexin ammonium
- type
- EXPERIMENTAL
- label
- Dose Level 1c
- description
- 3.33 mg/m2 dose of PT523 administered days 1, 8 and 15 of a 28-day cycle as a 5 minute IV infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of malignant solid tumor * Metastatic or inoperable disease * No known curative or survival-prolonging palliative therapy exists OR failed these prior therapies * No leukemia * No primary CNS tumor * No third-space fluid collection (i.e., pleural effusion, ascites) * Clinically insignificant small pleural or peritoneal effusions identified by CT scan, MRI, or other diagnostic test allowed * No active\* brain metastases, including the following: * Evidence of cerebral edema by CT scan or MRI * Progression since prior imaging study * Requirement for steroids * Clinical symptoms of/from brain metastases NOTE: \*Treated and/or stable brain metastasis allowed provided patient is asymptomatic PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 2 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * RBC folate ≥ lower limit of normal Hepatic * Bilirubin normal * SGOT and SGPT ≤ 2.5 times upper limit of normal Renal * Creatinine clearance ≥ 50 mL/min Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other uncontrolled serious medical or psychiatric illness PRIOR CONCURRENT THERAPY: Biologic therapy * No prior bone marrow transplantation Chemotherapy * More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy * See Disease Characteristics Radiotherapy * More than 3 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * At least 3 weeks since prior surgery Other * Recovered from prior therapy * More than 3 weeks since prior antifolate therapy
References
Publications (0)
Data not yet available
No reference posted for this study.