RAV12 in Treating Patients With Metastatic or Recurrent Adenocarcinoma
Cancer

About this trial
This is an interventional treatment trial for Cancer focused on measuring adenocarcinoma of the bladder, adenocarcinoma of the colon, adenocarcinoma of the esophagus, adenocarcinoma of the extrahepatic bile duct, adenocarcinoma of the gallbladder, adenocarcinoma of the lung, adenocarcinoma of the pancreas, adenocarcinoma of the prostate, adenocarcinoma of the rectum, adenocarcinoma of the stomach, adenocarcinoma with squamous metaplasia of the gallbladder, cervical adenocarcinoma, endometrial adenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian undifferentiated adenocarcinoma, salivary gland adenocarcinoma, small intestine adenocarcinoma, vaginal adenocarcinoma, vaginal clear cell adenocarcinoma, ovarian clear cell cystadenocarcinoma, ovarian mucinous cystadenocarcinoma, ovarian serous cystadenocarcinoma, stage IV bladder cancer, stage IV breast cancer, stage IV colon cancer, stage IV endometrial carcinoma, stage IV esophageal cancer, stage IV gastric cancer, stage IV non-small cell lung cancer, stage IV ovarian epithelial cancer, stage IV prostate cancer, stage IV rectal cancer, stage IV renal cell cancer, stage IV salivary gland cancer, stage IVA cervical cancer, stage IVA vaginal cancer, stage IVB cervical cancer, stage IVB vaginal cancer, recurrent bladder cancer, recurrent breast cancer, recurrent cervical cancer, recurrent colon cancer, recurrent endometrial carcinoma, recurrent esophageal cancer, recurrent extrahepatic bile duct cancer, recurrent gallbladder cancer, recurrent gastric cancer, recurrent non-small cell lung cancer, recurrent ovarian epithelial cancer, recurrent pancreatic cancer, recurrent prostate cancer, recurrent rectal cancer, recurrent renal cell cancer, recurrent salivary gland cancer, recurrent small intestine cancer, recurrent vaginal cancer, unresectable extrahepatic bile duct cancer, unresectable gallbladder cancer, stage IV pancreatic cancer
Eligibility 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
Sites / Locations
- Premiere Oncology
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
- University of Miami Sylvester Comprehensive Cancer Center - Miami
- Fox Chase Cancer Center - Philadelphia
- Sarah Cannon Cancer Center at Centennial Medical Center
Arms of the Study
Arm 1
Experimental
RAV12