Interleukin-12 and Trastuzumab in Treating Patients With Cancer That Has High Levels of HER2/Neu

Completed · Phase 1

Conditions studied: Advanced Adult Primary Liver Cancer, Anaplastic Thyroid Cancer, Bone Metastases, Carcinoma of the Appendix, Distal Urethral Cancer, Fallopian Tube Cancer, Gastrinoma, Glucagonoma, Inflammatory Breast Cancer, Insulinoma, Liver Metastases, Localized Unresectable Adult Primary Liver Cancer, Lung Metastases, Male Breast Cancer, Malignant Pericardial Effusion, Malignant Pleural Effusion, Metastatic Gastrointestinal Carcinoid Tumor, Metastatic Parathyroid Cancer, Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter, Newly Diagnosed Carcinoma of Unknown Primary, Occult Non-small Cell Lung Cancer, Pancreatic Polypeptide Tumor, Primary Peritoneal Cavity Cancer, Proximal Urethral Cancer, Pulmonary Carcinoid Tumor, Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Adrenocortical Carcinoma, Recurrent Adult Primary Liver Cancer, Recurrent Anal Cancer, Recurrent Bladder Cancer, Recurrent Breast Cancer, Recurrent Carcinoma of Unknown Primary, Recurrent Cervical Cancer, Recurrent Colon Cancer, Recurrent Endometrial Carcinoma, Recurrent Esophageal Cancer, Recurrent Extrahepatic Bile Duct Cancer, Recurrent Gallbladder Cancer, Recurrent Gastric Cancer, Recurrent Gastrointestinal Carcinoid Tumor, Recurrent Islet Cell Carcinoma, Recurrent Malignant Testicular Germ Cell Tumor, Recurrent Mucoepidermoid Carcinoma of the Oral Cavity, Recurrent Non-small Cell Lung Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Pancreatic Cancer, Recurrent Parathyroid Cancer, Recurrent Prostate Cancer, Recurrent Rectal Cancer, Recurrent Renal Cell Cancer, Recurrent Salivary Gland Cancer, Recurrent Small Intestine Cancer, Recurrent Squamous Cell Carcinoma of the Larynx, Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Nasopharynx, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Thyroid Cancer, Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter, Recurrent Urethral Cancer, Recurrent Vaginal Cancer, Recurrent Vulvar Cancer, Skin Metastases, Small Intestine Adenocarcinoma, Somatostatinoma, Stage III Adenoid Cystic Carcinoma of the Oral Cavity, Stage III Adrenocortical Carcinoma, Stage III Bladder Cancer, Stage III Cervical Cancer, Stage III Colon Cancer, Stage III Endometrial Carcinoma, Stage III Esophageal Cancer, Stage III Follicular Thyroid Cancer, Stage III Gastric Cancer, Stage III Malignant Testicular Germ Cell Tumor, Stage III Mucoepidermoid Carcinoma of the Oral Cavity, Stage III Ovarian Epithelial Cancer, Stage III Pancreatic Cancer, Stage III Papillary Thyroid Cancer, Stage III Prostate Cancer, Stage III Rectal Cancer, Stage III Renal Cell Cancer, Stage III Salivary Gland Cancer, Stage III Squamous Cell Carcinoma of the Larynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Squamous Cell Carcinoma of the Nasopharynx, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage III Vaginal Cancer, Stage III Vulvar Cancer, Stage IIIA Anal Cancer, Stage IIIA Breast Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Anal Cancer, Stage IIIB Breast Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Adenoid Cystic Carcinoma of the Oral Cavity, Stage IV Adrenocortical Carcinoma, Stage IV Anal Cancer, Stage IV Bladder Cancer, Stage IV Breast Cancer, Stage IV Colon Cancer, Stage IV Endometrial Carcinoma, Stage IV Esophageal Cancer, Stage IV Follicular Thyroid Cancer, Stage IV Gastric Cancer, Stage IV Mucoepidermoid Carcinoma of the Oral Cavity, Stage IV Non-small Cell Lung Cancer, Stage IV Ovarian Epithelial Cancer, Stage IV Pancreatic Cancer, Stage IV Papillary Thyroid Cancer, Stage IV Prostate Cancer, Stage IV Rectal Cancer, Stage IV Renal Cell Cancer, Stage IV Salivary Gland Cancer, Stage IV Squamous Cell Carcinoma of the Larynx, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IV Squamous Cell Carcinoma of the Nasopharynx, Stage IV Squamous Cell Carcinoma of the Oropharynx, Stage IVA Cervical Cancer, Stage IVA Vaginal Cancer, Stage IVB Cervical Cancer, Stage IVB Vaginal Cancer, Stage IVB Vulvar Cancer, Thyroid Gland Medullary Carcinoma, Unresectable Extrahepatic Bile Duct Cancer, Unresectable Gallbladder Cancer, Urethral Cancer Associated With Invasive Bladder Cancer, WDHA Syndrome

In brief

Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Phase I trial to study the effectiveness of interleukin-12 and trastuzumab in treating patients who have cancer that has high levels of HER2/neu and has not responded to previous therapy

Key facts

Study ID: NCT00004074
Run by: National Cancer Institute (NCI)
People needed: 15
Starts: 1999-08-01
Last updated by the study team: 2013-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have a histologically proven Her2 overexpressing malignancy as determined by any standardized assay currently in clinical use
Patients must have measurable or evaluable disease
The patient must have failed standard curative and/or palliative therapies for their disease
Life expectancy of at least 6 months
No concurrent malignancy other than non-melanoma skin carcinoma
Adequate hematopoietic, cardiac, renal, and hepatic function
Calculated creatinine clearance will be used to assess renal function
Karnofsky Performance Status index >= 70%
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation; a woman of childbearing potential is defined as a female who is biologically capable of becoming pregnant
Normal cardiac ejection fraction by echocardiogram or MUGA (i.e., greater than OSU lower limit of normal)
Written signed informed consent; the patient must be aware that his/her disease is neoplastic in nature and willingly consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts

You may not qualify if…

History of significant peripheral neuropathy or significant central nervous system disease
Brain or central nervous system metastasis at entry
Active or unstable cardiovascular disease or cardiac disease requiring drug or device intervention; history of coronary artery disease or congestive heart failure
Pregnant or nursing women
Surgery, radiotherapy, chemotherapy, or hormonal therapy during the three weeks prior to the initiation of therapy
Exposure to any investigational drug within three weeks prior to the start of dosing
Concurrent use of systemic corticosteroids
Known seropositive for hepatitis B surface antigen
Known seropositive for HIV antibody
Serious concurrent infection requiring intravenous antibiotic therapy
Clinically significant autoimmune disease (e.g., rheumatoid arthritis)
Clinically significant gastrointestinal bleeding or uncontrolled peptic ulcer disease
History of inflammatory bowel disease
Any other major illness which, in the investigator's judgment, will substantially increase the risk associated with the patient's participation in this study
Prior therapy with Herceptin

Where it is running

Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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