Status:
COMPLETED
3-AP in Treating Patients With Advanced or Metastatic Solid Tumors
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of 3-AP in treating patients with advanced or metastatic solid tumors. 3-AP may stop the growth of tumor cells by blocking some of the enz...
Detailed Description
OBJECTIVES: I. Determine the safety, tolerability, and toxicity of oral 3-AP in patients with advanced solid tumors. II. Determine the maximum tolerated dose and recommended phase II dose of this dr...
Eligibility Criteria
Inclusion
- Criteria:
- Must be able to swallow
- Histologically confirmed solid tumor
- Advanced or metastatic disease
- Measurable or evaluable disease
- No known active CNS metastases
- ECOG performance status 0-1
- Life expectancy \> 3 months
- Progressive disease during \>= 1 prior standard therapy OR disease unlikely to respond to any currently available therapies
- Patients with previously treated CNS metastases who have no evidence of new CNS metastases AND are stable for \>= 2 months are eligible
- Platelet count \>= 100,000/mm\^3
- Hemoglobin \>= 10 g/dL (transfusions allowed)
- Absolute neutrophil count \>= 1,500/mm\^3
- ALT and AST =\< 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase =\< 2.5 times ULN
- Creatinine =\< 1.5 mg/dL OR creatinine clearance \>= 50 mL/min
- Bilirubin normal
- PT/PTT =\< 1.5 times ULN
- FEV1 \>= 1.2 L
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception 2 weeks prior to and during study treatment
- No mental deficits and/or psychiatric history that may preclude study treatment
- No active heart disease, including any of the following: myocardial infarction within the past 3 months, symptomatic coronary artery disease or heart block, uncontrolled congestive heart failure
- No moderate to severe compromise of pulmonary function
- No active infection
- No other life-threatening illness
- No active coagulation disorder other than occult blood
- No known positivity for glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Recovered from prior treatment
- Prior gemcitabine allowed
- More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- More than 3 weeks since prior radiotherapy or any other treatment for this cancer
- No prior 3-AP
- No concurrent radiotherapy
- No other concurrent investigational agent
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00390052
Start Date
December 1 2006
Last Update
December 16 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
City of Hope
Duarte, California, United States, 91010