RAV12 in Treating Patients With Metastatic or Recurrent Adenocarcinoma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed adenocarcinoma
• •* Metastatic or recurrent disease
• •* Not curable by standard therapies
• •Must have failed at least 1, but no more than 3, prior therapies for metastatic or recurrent disease
• •* Patients with colorectal or breast adenocarcinoma must have failed at least 2 prior therapies
• •* Must have had at least stable disease for 3 months while on last treatment prior to most recent disease progression
• •Meets 1 of the following criteria:
• •* At least 1 measurable site of disease ≥ 2 cm by radiography
• •* Evaluable disease that could be reliably and consistently followed, as deemed by the principal investigator
• •RAAG12 expression confirmed\* by immunohistochemistry NOTE: \*Not required for patients with colon, pancreatic, or gastric adenocarcinoma
• •No evidence of residual or recurrent CNS metastases
• •Hormone receptor status:
• •* Not specified
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Sex
• •Not specified
• •Menopausal status
• •Not specified
• •Performance status
• •ECOG 0-1
• •Life expectancy
• •More than 3 months
• •Hematopoietic
• •Platelet count ≥ 100,000/mm\^3
• •Hemoglobin ≥ 9.0 g/dL (transfusions allowed)
• •Absolute neutrophil count ≥ 1,500/mm\^3
• •Hepatic
• •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• •AST and ALT ≤ 2.5 times ULN
• •Alkaline phosphatase ≤ 2.5 times ULN
• •γ-glutamyl transferase ≤ 2.5 times ULN
• •Adequate hepatic function sufficient to undergo study therapy
• •Renal
• •Creatinine \< 1.5 mg/dL
• •Adequate renal function sufficient to undergo study therapy
• •Cardiovascular
• •No New York Heart Association class III or IV heart disease
• •No thrombosis within the past 3 months, including any of the following:
• •* Deep vein thrombosis
• •* Myocardial infarction
• •* Stroke
• •Adequate cardiac function sufficient to undergo study therapy
• •Pulmonary
• •No pulmonary embolism within the past 3 months
• •No significant pulmonary compromise, particularly dependence on supplemental oxygen on an as-needed or continuous basis
• •Adequate pulmonary function sufficient to undergo study therapy
• •Immunologic
• •No active viral, bacterial or systemic fungal infection requiring parenteral therapy within the past 4 weeks
• •No history of chronic or recurrent infection requiring continual antiviral, antifungal, or antibacterial agents
• •No known hypersensitivity to murine or recombinant proteins, polysorbate 80, or any excipient contained in study drug
• •Other
• •Amylase and lipase normal
• •No other primary malignancy within the past 3 years except for the following:
• •* Treated non-melanoma skin cancer
• •* Carcinoma in situ of the cervix by biopsy
• •* Squamous intraepithelial lesion of the cervix by PAP smear
• •* Localized prostate cancer (Gleason score \< 6)
• •* Resected melanoma in situ
• •No other serious medical condition that would preclude study participation
• •No dementia or altered mental status that would preclude giving informed consent
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for 3 months after study participation
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •At least 3 half-lives since prior monoclonal antibody therapy
• •No concurrent vaccinations
• •No concurrent prophylactic hematologic growth factors
• •Chemotherapy
• •At least 4 weeks since prior chemotherapy
• •Endocrine therapy
• •No concurrent steroids except for the following:
• •* Inhaled, ophthalmic, or nasal steroids
• •* Stable dose of oral prednisone (or equivalent) ≤ 10 mg/day
• •Radiotherapy
• •At least 4 weeks since prior radiotherapy
• •Surgery
• •More than 4 weeks since prior major surgery
• •Other
• •More than 4 weeks since prior investigational agents
• •Prior oral antiviral, antifungal, or antibacterial therapy allowed provided therapy was completed within the past week
• •No other concurrent antineoplastic therapy
• •No concurrent immunosuppressive medications
• •No other concurrent investigational agents
• •No concurrent vitamins except those approved by the medical monitor
• •* Concurrent daily multivitamin allowed
• •Concurrent bisphosphonates allowed provided patient is on stable dose for ≥ 1 month prior to study entry