Clinical trial NCT01212887 (phase 1, status: terminated)
Conditions: breast cancer, colorectal cancer, gastric cancer, lung cancer, ovarian cancer, pancreatic cancer, unspecified adult solid tumor, protocol specific
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C25.3, H01.009, H02.209, H02.009, H02.109, H04.209, H05.409, H10.509
Drugs: cyclophosphamide, fludarabine phosphate
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, NC1=NC(F)=NC2=C1N=CN2[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O
Reason stopped: 
    due to safety concerns and lack of efficacy
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed malignancy

               -  Metastatic or unresectable disease

               -  Standard curative or palliative measures do not exist, are no longer effective,
                  have been completed, or have been refused

          -  CEA-positive tumor (either by immunohistochemistry or as demonstrated by elevated CEA
             > 50 μg/L)

          -  No primary brain tumor or brain metastases

        PATIENT CHARACTERISTICS:

          -  WHO performance status 0-1

          -  Life expectancy ≥ 3 months

          -  Hemoglobin ≥ 10 g/dL

          -  Platelet count ≥ 100 x 10^9/L

          -  Neutrophil count ≥ 2.0 x 10^9/L

          -  Lymphocyte count ≥ 1.0 x 10^9/L

          -  Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  ALT/AST ≤ 5 times ULN

          -  Alkaline phosphatase ≤ 5 times ULN

          -  Calculated creatinine clearance OR isotope clearance measurement ≥ 50 mL/min

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception 4 weeks prior to, during, and for 6
             months after completion of study therapy (male patients must use barrier-method
             contraception)

          -  LVEF ≥ 50% on MUGA scan (for patients receiving cyclophosphamide)

          -  ECG and exercise ECG (or stress ECHO) normal (may be abnormal but not clinically
             significant)

          -  Urine dipstick normal (may be abnormal but not clinically significant)

          -  No medical high risk due to nonmalignant systemic disease including active
             uncontrolled infection

          -  No known serologically positive hepatitis B, hepatitis C, HIV, or HTLV

          -  No history of autoimmune disease

          -  No inflammatory bowel disease

          -  No concurrent congestive heart failure or prior history of NYHA class III-IV cardiac
             disease

          -  No concurrent malignancies originating from other primary sites, except for adequately
             treated cone-biopsied carcinoma in situ of the cervix uteri or basal cell or squamous
             cell carcinoma of the skin

          -  No other condition that, in the investigator's opinion, would make the patient an
             unsuitable candidate for the clinical trial

        PRIOR CONCURRENT THERAPY:

          -  At least 30 days since prior and no concurrent participation in another clinical trial

          -  At least 4 weeks since prior and no concurrent radiotherapy (except for palliative
             reasons [i.e., control of bone pain])

          -  At least 4 weeks since prior and no concurrent endocrine therapy, immunotherapy, or
             chemotherapy (6 weeks for nitrosoureas and mitomycin C)

          -  No toxic manifestations of previous treatment, except for alopecia or certain grade 1
             toxicities that, in the opinion of the investigator and CRUK (Cancer Research UK),
             would exclude the patient (e.g., grade 1 neuropathy or grade 1 fatigue)

          -  No prior major thoracic and/or abdominal surgery from which the patient has not yet
             recovered

          -  No prior bone marrow transplant or extensive radiotherapy to > 25% of bone marrow

          -  No concurrent systemic steroids or other immunosuppressive therapy

          -  No other concurrent anticancer therapy or investigational drugs