PR104 and G-CSF in Treating Patients With Solid Tumors
Completed · Phase 1
Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific
In brief
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 factors, such as G-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving PR-104 together with G-CSF may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 when given together with G-CSF in treating patients with solid tumors.
Key facts
- Study ID
- NCT00616213
- Run by
- Proacta, Incorporated
- People needed
- 5
- Starts
- 2008-02-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2011-06-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea — Scottsdale, Arizona, United States
- South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States
- Waikato Hospital — Hamilton, New Zealand
Full record on ClinicalTrials.gov
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