| Inclusion Criteria: | 1) Patients with: a) recurrent epithelial cancer of the ovary, peritoneium, or fallopian tube (any stage) who have failed a platinum and taxane-containing regimen. These patients will have persistent or recurrent disease following treatment, including, primary surgery and primary chemotherapy, but they may not have received more than two lines of conventional cytotoxic chemotherapy in the recurrent setting; or b) stage IV (AJCC) colorectal cancer with not more than two prior cytotoxic chemotherapy-based regimens,
2) (Criterion #1cont'd) including adjuvant treatment; and evidence of disease recurrence at the time of study screening, documented by appearance of new lesions(s) or increase in measurable disease according to RECIST criteria, rising tumor marker, or clinical progression; or c) metastatic hormone-refractory prostate cancer who have documented progressive disease and have failed at least one but no more than two conventional cytotoxic therapies and do not have brain or lung metastases;
3) (Inclusion #1 cont'd) or d) stage IV (AJCC) renal cell cancer who have not had previous immune based therapies, such as IL-2 and Stage II renal cancer patients who have had IFN treatment greater than 6 months prior to enrollment; or e) stage IV breast cancer whose disease has progressed despite recediving at least one but no more than two conventional cytotoxic therapies.
4) Evidence of measurable disease by clinical or radiographic assessment or by tumor biomarker (ovarian and prostate cancer)
5) Age >/= 18 years old
6) A baseline ECOG status of 0 or 1
7) A life expectancy > 6 months
8) Adequate hematologic function established within 14 days prior to receipt of the first dose of cyclophosphamide, defined as: a) absolute lymphocyte count >/= 1,000/mm^2; b) WBC >/= 3,000/mm^2; c) platelet count >/= 75,000/mm^2; and hemoglobin >/= 9 g/dL
9) Adequate renal function established within 14 days rior to receipt of the first dose of cyclophosphamide, defined as serum creatinine </= 1.5 x upper limit of normal
10) Adequate hepatic function established within 14 days prior to receipt of the first dose of cyclophosphamide, defined as: a) total bilirubin </= 1.5 x upper limit normal, and b) AST and ALT </= 2.5 x upper limit of normal.
11) An MRI of the brain, if clinically indicated, that is negative for parenchymal central nervous system metastases within 28 days prior to receipt of the first dose of cyclophosphamide. If a patient cannot undergo an MRI because of a medical contraindication, a contrast CT of the brain will be acceptable.
12) A negative pregnancy test (blood or urine) within 14 days prior to receipt of the first dose of cyclophosphamide (where applicable), when applicable (excludes men, documented surgically sterile and post-menopausal women).
13) Agree to use appropriate contraception (see Section 3.7 of protocol) from study entry until the end-of-observation visit (excludes documented surgically sterile women/men and documented post-menopausal women).
14) A signed informed consent form approved by the Institutional Review Board. |