- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004074
Interleukin-12 and Trastuzumab in Treating Patients With Cancer That Has High Levels of HER2/Neu
A Phase I Trial of Herceptin and Interleukin-12
Study Overview
Status
Conditions
- Recurrent Prostate Cancer
- Fallopian Tube Cancer
- Bone Metastases
- Lung Metastases
- Stage III Renal Cell Cancer
- Liver Metastases
- Recurrent Thyroid Cancer
- Stage IV Follicular Thyroid Cancer
- Stage IV Papillary Thyroid Cancer
- Inflammatory Breast Cancer
- Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
- Recurrent Bladder Cancer
- Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
- Stage III Bladder Cancer
- Stage IV Bladder Cancer
- Recurrent Pancreatic Cancer
- Stage III Pancreatic Cancer
- Stage IV Pancreatic Cancer
- Recurrent Endometrial Carcinoma
- Male Breast Cancer
- Stage IV Breast Cancer
- Stage IV Ovarian Epithelial Cancer
- Primary Peritoneal Cavity Cancer
- Stage IIIA Non-small Cell Lung Cancer
- Stage IIIB Non-small Cell Lung Cancer
- Stage IIIA Breast Cancer
- Stage IIIB Breast Cancer
- Gastrinoma
- Glucagonoma
- Insulinoma
- Metastatic Gastrointestinal Carcinoid Tumor
- Pancreatic Polypeptide Tumor
- Recurrent Gastrointestinal Carcinoid Tumor
- Recurrent Islet Cell Carcinoma
- Somatostatinoma
- WDHA Syndrome
- Anaplastic Thyroid Cancer
- Stage III Prostate Cancer
- Stage IV Renal Cell Cancer
- Recurrent Renal Cell Cancer
- Stage IV Prostate Cancer
- Recurrent Breast Cancer
- Recurrent Ovarian Epithelial Cancer
- Stage IV Colon Cancer
- Stage IV Rectal Cancer
- Stage IV Gastric Cancer
- Stage IV Endometrial Carcinoma
- Recurrent Colon Cancer
- Recurrent Rectal Cancer
- Recurrent Gastric Cancer
- Recurrent Salivary Gland Cancer
- Recurrent Squamous Cell Carcinoma of the Larynx
- Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
- Recurrent Squamous Cell Carcinoma of the Oropharynx
- Recurrent Non-small Cell Lung Cancer
- Stage IV Non-small Cell Lung Cancer
- Advanced Adult Primary Liver Cancer
- Carcinoma of the Appendix
- Localized Unresectable Adult Primary Liver Cancer
- Recurrent Adult Primary Liver Cancer
- Recurrent Extrahepatic Bile Duct Cancer
- Recurrent Gallbladder Cancer
- Recurrent Small Intestine Cancer
- Small Intestine Adenocarcinoma
- Stage III Colon Cancer
- Stage III Gastric Cancer
- Stage III Ovarian Epithelial Cancer
- Stage III Rectal Cancer
- Unresectable Extrahepatic Bile Duct Cancer
- Unresectable Gallbladder Cancer
- Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
- Recurrent Mucoepidermoid Carcinoma of the Oral Cavity
- Recurrent Squamous Cell Carcinoma of the Nasopharynx
- Stage III Adenoid Cystic Carcinoma of the Oral Cavity
- Stage III Mucoepidermoid Carcinoma of the Oral Cavity
- 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 IV Adenoid Cystic Carcinoma of the Oral Cavity
- Stage IV Mucoepidermoid Carcinoma of the Oral Cavity
- 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
- Malignant Pleural Effusion
- Recurrent Esophageal Cancer
- Stage IV Esophageal Cancer
- Stage III Vulvar Cancer
- Stage IVB Vulvar Cancer
- Recurrent Cervical Cancer
- Recurrent Vaginal Cancer
- Recurrent Vulvar Cancer
- Stage III Cervical Cancer
- Stage III Vaginal Cancer
- Stage IVA Cervical Cancer
- Stage IVA Vaginal Cancer
- Stage IVB Cervical Cancer
- Stage IVB Vaginal Cancer
- Recurrent Adrenocortical Carcinoma
- Stage III Adrenocortical Carcinoma
- Stage IV Adrenocortical Carcinoma
- Stage III Esophageal Cancer
- Recurrent Malignant Testicular Germ Cell Tumor
- Stage III Malignant Testicular Germ Cell Tumor
- Distal Urethral Cancer
- Proximal Urethral Cancer
- Recurrent Urethral Cancer
- Urethral Cancer Associated With Invasive Bladder Cancer
- Stage III Follicular Thyroid Cancer
- Stage III Papillary Thyroid Cancer
- Thyroid Gland Medullary Carcinoma
- Pulmonary Carcinoid Tumor
- Recurrent Anal Cancer
- Stage IV Anal Cancer
- Malignant Pericardial Effusion
- Stage III Endometrial Carcinoma
- Skin Metastases
- Metastatic Parathyroid Cancer
- Recurrent Parathyroid Cancer
- Newly Diagnosed Carcinoma of Unknown Primary
- Occult Non-small Cell Lung Cancer
- Recurrent Carcinoma of Unknown Primary
- Stage IIIA Anal Cancer
- Stage IIIB Anal Cancer
Intervention / Treatment
Detailed 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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Ohio State University Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment (IL12 and trastuzumab)
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.
|
Given IV
Other Names:
Given IV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Up to 52 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: William Carson, Ohio State University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Skin Diseases
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Urinary Bladder Diseases
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Endocrine System Diseases
- Disease Attributes
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Pleural Diseases
- Endocrine Gland Neoplasms
- Genital Neoplasms, Male
- Testicular Diseases
- Breast Diseases
- Liver Diseases
- Prostatic Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Parathyroid Diseases
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Mouth Diseases
- Neuroectodermal Tumors
- Neoplasms, Nerve Tissue
- Colonic Diseases
- Intestinal Diseases
- Rectal Diseases
- Neoplastic Processes
- Esophageal Diseases
- Fallopian Tube Diseases
- Colorectal Neoplasms
- Gallbladder Diseases
- Biliary Tract Diseases
- Pancreatic Diseases
- Neuroendocrine Tumors
- Vaginal Diseases
- Neoplasms, Squamous Cell
- Vulvar Diseases
- Neoplasms, Cystic, Mucinous, and Serous
- Adenoma
- Ovarian Neoplasms
- Nasopharyngeal Neoplasms
- Ureteral Diseases
- Bile Duct Diseases
- Salivary Gland Diseases
- Adenocarcinoma, Papillary
- Pleural Neoplasms
- Adrenal Gland Diseases
- Anus Diseases
- Carcinoma, Neuroendocrine
- Urethral Diseases
- Mouth Neoplasms
- Biliary Tract Neoplasms
- Neoplasms, Ductal, Lobular, and Medullary
- Adrenal Cortex Neoplasms
- Adrenal Gland Neoplasms
- Adrenal Cortex Diseases
- Adenoma, Islet Cell
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Uterine Cervical Neoplasms
- Stomach Neoplasms
- Neoplasms, Germ Cell and Embryonal
- Testicular Neoplasms
- Breast Neoplasms
- Prostatic Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Carcinoma
- Nasopharyngeal Carcinoma
- Neoplasm Metastasis
- Recurrence
- Fallopian Tube Neoplasms
- Thyroid Diseases
- Urinary Bladder Neoplasms
- Rectal Neoplasms
- Endometrial Neoplasms
- Carcinoma, Adenoid Cystic
- Pancreatic Neoplasms
- Gastrointestinal Neoplasms
- Carcinoma, Ovarian Epithelial
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Vulvar Neoplasms
- Cholangiocarcinoma
- Liver Neoplasms
- Esophageal Neoplasms
- Colonic Neoplasms
- Carcinoma, Transitional Cell
- Thyroid Neoplasms
- Thyroid Cancer, Papillary
- Adenocarcinoma, Follicular
- Inflammatory Breast Neoplasms
- Intestinal Neoplasms
- Ureteral Neoplasms
- Anus Neoplasms
- Neoplasms, Unknown Primary
- Oropharyngeal Neoplasms
- Urethral Neoplasms
- Vaginal Neoplasms
- Breast Neoplasms, Male
- Pleural Effusion, Malignant
- Pleural Effusion
- Salivary Gland Neoplasms
- Carcinoid Tumor
- Gallbladder Neoplasms
- Malignant Carcinoid Syndrome
- Carcinoma, Islet Cell
- Adrenocortical Carcinoma
- Insulinoma
- Gastrinoma
- Glucagonoma
- Somatostatinoma
- Vipoma
- Laryngeal Neoplasms
- Parathyroid Neoplasms
- Laryngeal Diseases
- Bile Duct Neoplasms
- Carcinoma, Medullary
- Pericardial Effusion
- Thyroid Carcinoma, Anaplastic
- Carcinoma, Mucoepidermoid
- Mucoepidermoid Tumor
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Adjuvants, Immunologic
- Carboplatin
- Trastuzumab
- Albumin-Bound Paclitaxel
- Interleukin-12
Other Study ID Numbers
- NCI-2012-01398
- U01CA076576 (U.S. NIH Grant/Contract)
- 99H0185
- CDR0000067282 (REGISTRY: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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