A Phase I Study Of PT523 In Patients With Solid Tumors
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase I Study Of PT523 In Patients With Solid Tumors
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Joseph Paul Eder, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000400150
NCT ID:
NCT00098514
Start Date:
October 2004
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
