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Clinical Trial 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


Clinical Trial Description

OBJECTIVES:

I. Determine the maximum tolerated dose of interleukin-12 (IL-12) when combined with trastuzumab in patients with HER2-Neu overexpressing malignancies.

II. Determine the safety of this regimen in these patients.

III. Analyze any expression of interferon-inducible genes in tumor tissues of these patients after receiving this regimen.

IV. Characterize natural killer cytokine production in patients treated with this regimen.

V. Determine serum interferon gamma levels in patients treated with this regimen.

OUTLINE:

This is a dose escalation study of interleukin-12 (IL-12).

Patients receive an initial loading dose of trastuzumab IV over 90 minutes on day 1 of the first week and a maintenance dose of trastuzumab IV over 30-90 minutes on day 1 of each subsequent week. Patients receive IL-12 IV on days 2 and 5 beginning on week 3. Treatment with maintenance trastuzumab and IL-12 repeats weekly for 14 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease continue treatment for up to 38 additional weeks.

Cohorts of 3-6 patients receive escalating doses of IL-12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

Patients are followed every 3 months for 1 year and then every 6 months thereafter for survival.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 6 months. ;


Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Adrenocortical Carcinoma
  • Advanced Adult Primary Liver Cancer
  • Anaplastic Thyroid Cancer
  • Anus Neoplasms
  • Appendiceal Neoplasms
  • Bile Duct Neoplasms
  • Bone Metastases
  • Breast Neoplasms
  • Breast Neoplasms, Male
  • Carcinoid Tumor
  • Carcinoma
  • Carcinoma of the Appendix
  • Carcinoma, Adenoid Cystic
  • Carcinoma, Islet Cell
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Carcinoma, Squamous Cell
  • Carcinoma, Transitional Cell
  • Cholangiocarcinoma
  • Distal Urethral Cancer
  • Endometrial Neoplasms
  • Esophageal Neoplasms
  • Fallopian Tube Cancer
  • Gallbladder Neoplasms
  • Gastrinoma
  • Gastrointestinal Neoplasms
  • Glucagonoma
  • Inflammatory Breast Cancer
  • Insulinoma
  • Kidney Neoplasms
  • Laryngeal Diseases
  • Laryngeal Neoplasms
  • Liver Metastases
  • Liver Neoplasms
  • Localized Unresectable Adult Primary Liver Cancer
  • Lung Metastases
  • Lung Neoplasms
  • Male Breast Cancer
  • Malignant Carcinoid Syndrome
  • Malignant Pericardial Effusion
  • Malignant Pleural Effusion
  • Metastatic Gastrointestinal Carcinoid Tumor
  • Metastatic Parathyroid Cancer
  • Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Nasopharyngeal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Germ Cell and Embryonal
  • Neoplasms, Glandular and Epithelial
  • Neoplasms, Unknown Primary
  • Neuroendocrine Tumors
  • Newly Diagnosed Carcinoma of Unknown Primary
  • Occult Non-small Cell Lung Cancer
  • Oropharyngeal Neoplasms
  • Ovarian Neoplasms
  • Pancreatic Neoplasms
  • Pancreatic Polypeptide Tumor
  • Pericardial Effusion
  • Peritoneal Neoplasms
  • Pleural Effusion
  • Pleural Effusion, Malignant
  • Primary Peritoneal Cavity Cancer
  • Prostatic Neoplasms
  • Proximal Urethral Cancer
  • Pulmonary Carcinoid Tumor
  • Rectal Neoplasms
  • 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
  • Salivary Gland Neoplasms
  • 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
  • Stomach Neoplasms
  • Testicular Neoplasms
  • Thyroid Diseases
  • Thyroid Gland Medullary Carcinoma
  • Thyroid Neoplasms
  • Unresectable Extrahepatic Bile Duct Cancer
  • Unresectable Gallbladder Cancer
  • Ureteral Neoplasms
  • Urethral Cancer Associated With Invasive Bladder Cancer
  • Urethral Neoplasms
  • Urinary Bladder Neoplasms
  • Uterine Cervical Neoplasms
  • Vaginal Neoplasms
  • Vipoma
  • Vulvar Neoplasms
  • WDHA Syndrome

NCT number NCT00004074
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 1
Start date August 1999

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