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

Summary

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

Conditions

• 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

Interventions

BIOLOGICAL

recombinant interleukin-12

Given IV

BIOLOGICAL

ABI-007/carboplatin/trastuzumab

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• William Carson · Ohio State University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1999-08-31

Primary Completion

2009-02-28

Countries

• United States

Study Locations