Status:
COMPLETED
Talotrexin in Treating Patients With Advanced or Recurrent Solid Tumors
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
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...
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. * Det...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00098514
Start Date
December 1 2003
End Date
May 1 2011
Last Update
December 18 2017
Active Locations (1)
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1
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115