Status:
COMPLETED
PR-104 in Treating Patients With Advanced Solid Tumors
Lead Sponsor:
Proacta, Incorporated
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as PR-104, 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 t...
Detailed Description
OBJECTIVES: Primary * Evaluate the safety and tolerability of PR-104 in patients with advanced solid tumors. * Determine the maximum tolerated dose of PR-104 in these patients. Secondary * Charact...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed solid tumor, meeting 1 of the following criteria:
- Not amenable to standard therapy
- Refractory to conventional therapy
- Measurable or evaluable disease
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Life expectancy \> 3 months
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin \> 9 g/L (transfusion independent)
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT and AST ≤ 2.5 times ULN
- Creatinine clearance ≥ 60 mL/min
- PT/INR or aPTT ≤ 1.1 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 30 days after completion of study treatment
- No significant cardiac comorbidity including any of the following:
- New York Heart Association class III-IV congenital heart failure
- LVEF \< 40%
- Unstable angina
- Myocardial infarction within the past 6 months
- Ventricular arrhythmias requiring drug therapy
- Pacemaker or implanted defibrillator
- No ongoing coagulopathy
- No uncontrolled infection or infection requiring parenteral antibiotics
- No other significant clinical disorder or laboratory finding that would preclude study treatment
- No known HIV positivity
- No known positivity for hepatitis B surface antigen or hepatitis C with abnormal liver tests
- No known allergy to nonplatinum-containing alkylating agents
- PRIOR CONCURRENT THERAPY:
- Recovered from prior therapy
- More than 2 weeks since prior hormonal therapy (except for androgen-deprivation therapy)
- More than 4 weeks since prior major surgery
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
- More than 4 weeks since prior radiotherapy
- More than 1 month since prior investigational drugs, therapies, or devices
- No prior radiotherapy to \> 25% of bone marrow
- No prior high-dose chemotherapy, either myeloablative or nonmyeloablative (mini-allogeneic transplant)
- No more than 3 prior myelosuppressive chemotherapy regimens
- Concurrent steroids allowed provided dose is stable for ≥ 2 weeks and clinical condition is stable for 1 month
- Nasal, opthalmologic, and topical glucocorticoid preparations allowed
- Physiologic hormone replacement therapies allowed (i.e., oral replacement glucocorticoid therapy for adrenal insufficiency)
- No concurrent prophylactic hematopoietic growth factors
- No concurrent radiotherapy, including local palliative radiotherapy or systemic radioisotopes
- Radioisotopes for protocol specified positron emission tomography allowed
- No other concurrent investigational agents
- No other concurrent chemotherapy, radiotherapy (including palliative local radiotherapy), hormonal therapy (except for androgen-deprivation therapy), and/or biological therapy (including immunotherapy)
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00349167
Start Date
December 1 2005
End Date
June 1 2007
Last Update
November 30 2012
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781