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Talotrexin in Treating Patients With Advanced or Recurrent Solid Tumors

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
ClinicalTrials.gov Identifier:
First Posted: December 8, 2004
Last Update Posted: July 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
December 7, 2004
December 8, 2004
July 24, 2008
October 2004
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Complete list of historical versions of study NCT00098514 on ClinicalTrials.gov Archive Site
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Talotrexin in Treating Patients With Advanced or Recurrent Solid Tumors
A Phase I Study Of PT523 In Patients With Solid Tumors

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.



  • Determine the maximum tolerated dose of talotrexin in patients in patients with advanced or recurrent solid tumors.
  • Determine the safety of this drug in these patients.
  • Determine the dose-limiting toxic effects of this drug in these patients.


  • Determine the pharmacokinetics of this drug in these patients.
  • Correlate pharmacokinetic parameters of this drug or patient characteristics with drug-related toxicity in these patients.
  • Determine, preliminarily, the antitumor efficacy of this drug in these patients.

OUTLINE: This is an open-label, dose-escalation, multicenter study.

Patients receive talotrexin IV over 5 minutes on day 1 OR days 1 and 8 OR days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 1-6 patients receive escalating doses of talotrexin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6-10 patients are treated at the MTD.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 9-12 months.

Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Drug: talotrexin ammonium
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
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  • 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



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 2 months


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • RBC folate ≥ lower limit of normal


  • Bilirubin normal
  • SGOT and SGPT ≤ 2.5 times upper limit of normal


  • Creatinine clearance ≥ 50 mL/min


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other uncontrolled serious medical or psychiatric illness


Biologic therapy

  • No prior bone marrow transplantation


  • More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

  • See Disease Characteristics


  • More than 3 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • At least 3 weeks since prior surgery


  • Recovered from prior therapy
  • More than 3 weeks since prior antifolate therapy
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: Joseph Paul Eder, MD Dana-Farber Cancer Institute
National Cancer Institute (NCI)
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP