Status:
COMPLETED
PR104 and G-CSF in Treating Patients With Solid Tumors
Lead Sponsor:
Proacta, Incorporated
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. Colony-stimulating facto...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of PR-104 in combination with filgrastim (G-CSF) in patients with solid tumors. Secondary * Characterize the safety of this regimen in th...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed solid tumors
- Measurable or evaluable disease
- PATIENT CHARACTERISTICS:
- Inclusion criteria:
- ECOG performance status 0-1
- Absolute neutrophil count ≥ 1.5 x 10\^9/L
- Platelet count ≥ 100 x 10\^9/L
- Hemoglobin ≥ 9 g/dL (no red blood cell transfusions allowed)
- Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- PTT ≤ 1.5 times normal
- Serum creatinine ≤ 1.5 times ULN
- ALT or AST ≤ 2 times ULN (≤ 5 times ULN if liver metastases are present)
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 30 days after completion of study therapy
- Able to read, understand, and provide written informed consent
- Exclusion criteria:
- Evidence of a significant medical disorder or laboratory finding that, in the opinion of the investigator, compromises the patient's safety during study participation, including any of the following:
- Uncontrolled infection or infection requiring a concomitant parenteral antibiotic
- Uncontrolled diabetes
- Congestive heart failure
- Myocardial infarction within the past 6 months
- Chronic renal disease
- Coagulopathy (excluding prophylactic anticoagulation)
- Known HIV positivity
- Hepatitis B sAg-positive or known to be hepatitis C-positive with abnormal liver function tests
- PRIOR CONCURRENT THERAPY:
- No more than 3 prior myelosuppressive chemotherapy regimens
- Patients who have received more than 3 prior myelosuppressive regimens may be eligible, if considered to have adequate marrow, based on prior exposure to 1 of the following regimens:
- Minimally myelosuppressive regimens
- Limited courses of myelosuppressive regimens
- More than 4 weeks since prior and no other concurrent licensed or investigational anticancer treatment (6 weeks for nitrosoureas or mitomycin C)
- More than 24 hours since any prior radiotherapy and no likelihood of toxicity from this therapy
- More than 4 weeks since major surgery
- No prior radiotherapy to \> 20% of bone marrow
- No prior high-dose chemotherapy (including either myeloablative or non-myeloablative transplantations)
- Prior and concurrent androgen deprivation therapy allowed
- Concurrent systemic steroids allowed, provided the patient has been on a stable dose for at least 2 weeks prior to first dose of PR-104
- No concurrent irradiation therapy (palliative or therapeutic), unless given in the absence of tumor progression
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00616213
Start Date
February 1 2008
End Date
June 1 2009
Last Update
June 1 2011
Active Locations (3)
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1
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
Scottsdale, Arizona, United States, 85258-4512
2
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
3
Waikato Hospital
Hamilton, New Zealand, 2020