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NCT Number: NCT00004074

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

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

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Key information

Conditions

Advanced Adult Primary Liver Cancer Adenocarcinoma Adenocarcinoma, Follicular Adenocarcinoma, Papillary Adenoma Adenoma, Islet Cell Adnexal Diseases Adrenal Cortex Diseases Adrenal Cortex Neoplasms Adrenal Gland Diseases Adrenal Gland Neoplasms Adrenocortical Carcinoma Anaplastic Thyroid Cancer Anus Diseases Anus Neoplasms Appendiceal Neoplasms Bile Duct Diseases Bile Duct Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Bone Metastases Breast Diseases Breast Neoplasms Breast Neoplasms, Male Bronchial Neoplasms Carcinoma Carcinoma of the Appendix Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Islet Cell Carcinoma, Medullary Carcinoma, Neuroendocrine Carcinoma, Non-Small-Cell Lung Carcinoma, Ovarian Epithelial Carcinoma, Renal Cell Carcinoma, Squamous Cell Cecal Diseases Cecal Neoplasms Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Distal Urethral Cancer Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Esophageal Diseases Esophageal Neoplasms Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gallbladder Diseases Gallbladder Neoplasms Gastrinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Glucagonoma Gonadal Disorders Head and Neck Neoplasms Inflammatory Breast Cancer Inflammatory Breast Neoplasms Insulinoma Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Liver Diseases Liver Metastases Liver Neoplasms Localized Unresectable Adult Primary Liver Cancer Lung Diseases Lung Metastases Lung Neoplasms Male Breast Cancer Male Urogenital Diseases Malignant Pericardial Effusion Malignant Pleural Effusion Metastatic Gastrointestinal Carcinoid Tumor Metastatic Parathyroid Cancer Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter Mouth Diseases Mouth Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Unknown Primary Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Newly Diagnosed Carcinoma of Unknown Primary Occult Non-small Cell Lung Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Diseases Pancreatic Neoplasms Pancreatic Polypeptide Tumor Parathyroid Diseases Parathyroid Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Pleural Diseases Pleural Effusion Pleural Effusion, Malignant Pleural Neoplasms Primary Peritoneal Cavity Cancer Prostatic Diseases Prostatic Neoplasms Proximal Urethral Cancer Pulmonary Carcinoid Tumor Rectal Diseases 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 Respiratory Tract Diseases Respiratory Tract Neoplasms Salivary Gland Diseases Salivary Gland Neoplasms Skin Diseases Skin Metastases Skin and Connective Tissue Diseases Small Intestine Adenocarcinoma Somatostatinoma Squamous Cell Carcinoma of Head and Neck 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 Diseases Stomach Neoplasms Stomatognathic Diseases Testicular Diseases Testicular Neoplasms Thoracic Neoplasms Thyroid Cancer, Papillary Thyroid Carcinoma, Anaplastic Thyroid Diseases Thyroid Gland Medullary Carcinoma Thyroid Neoplasms Unresectable Extrahepatic Bile Duct Cancer Unresectable Gallbladder Cancer Urethral Cancer Associated With Invasive Bladder Cancer Urethral Diseases Urethral Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vaginal Diseases Vaginal Neoplasms Vipoma Vulvar Diseases Vulvar Neoplasms WDHA Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

recombinant interleukin-12

Biological

Given IV

Other names: cytotoxic lymphocyte maturation factor, IL-12, interleukin-12, natural killer cell stimulatory factor, Ro 24-7472

ABI-007/carboplatin/trastuzumab

Biological

Given IV

Primary outcomes

  1. Maximum tolerated dose (MTD) determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 2.0 (CTCAE v2.0)

    Time frame: Up to 52 weeks

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

A Phase I Trial of Herceptin and Interleukin-12

Important dates

Study start
1999
Primary completion
2009
First posted
Oct 29, 2003
Registry last updated
Feb 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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