RAV12 in Treating Patients With Metastatic or Recurrent Adenocarcinoma

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