PR104 and G-CSF in Treating Patients With Solid Tumors

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