Talotrexin in Treating Patients With Advanced or Recurrent Solid Tumors
Recruitment status was Active, not recruiting
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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 |
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2004 |
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 |
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| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| 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 May 23, 2013