Talotrexin in Treating Patients With Advanced or Recurrent Solid Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00098514
First received: December 7, 2004
Last updated: July 23, 2008
Last verified: January 2007
  Purpose

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.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: talotrexin ammonium
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study Of PT523 In Patients With Solid Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 40
Study Start Date: October 2004
Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00098514

Locations
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Study Chair: Joseph Paul Eder, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00098514     History of Changes
Other Study ID Numbers: CDR0000400150, DFCI-02000, NCI-6400, DFCI-IRB-03183, HANABIO-DFCI-02000
Study First Received: December 7, 2004
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 29, 2014