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Interleukin-12, Paclitaxel, and Trastuzumab in Treating Patients With Solid Tumors

This study has been completed.
Information provided by (Responsible Party):
National Cancer Institute (NCI) Identifier:
First received: January 4, 2002
Last updated: June 3, 2013
Last verified: June 2013
Phase I trial to study the effectiveness of interleukin-12, paclitaxel, and trastuzumab in treating patients who have solid tumors. 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. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining interleukin-12, chemotherapy, and monoclonal antibody therapy may kill more tumor cells.

Condition Intervention Phase
Male Breast Cancer
Recurrent Breast Cancer
Recurrent Endometrial Carcinoma
Recurrent Gastric Cancer
Recurrent Non-small Cell Lung Cancer
Recurrent Ovarian Epithelial Cancer
Recurrent Small Cell Lung Cancer
Biological: trastuzumab
Drug: paclitaxel
Biological: recombinant interleukin-12
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of Interleukin-12 in Combination With Paclitaxel Plus Herceptin in Patients With Her2-positive Malignancies

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • MTD of IL-12, defined as the dose level one level beneath that dose at which 2 or more of 6 patients showed DLT, based on the NCI CTC version 2.0 [ Time Frame: Up to 21 days ]

Enrollment: 18
Study Start Date: November 2001
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15 and paclitaxel IV over 3 hours on day 1 of course 1. Beginning with course 2, patients receive trastuzumab and paclitaxel as in course 1 and interleukin-12 subcutaneously on days 2, 5, 9, 12, 16, and 19. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Biological: trastuzumab
Given IV
Other Names:
  • anti-c-erB-2
  • Herceptin
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Biological: recombinant interleukin-12
Given SC
Other Names:
  • cytotoxic lymphocyte maturation factor
  • IL-12
  • interleukin-12
  • natural killer cell stimulatory factor
  • Ro 24-7472

Detailed Description:


I. Determine the maximum tolerated dose of interleukin-12 when given in combination with paclitaxel and trastuzumab (Herceptin®) in patients with HER2/neu-overexpressing malignancies.

II. Determine the response rate and time to progression in patients treated with this regimen.

III. Determine the anti-tumor effect of this regimen in these patients.

OUTLINE: This is a dose-escalation study of interleukin-12.

Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15 and paclitaxel IV over 3 hours on day 1 of course 1. Beginning with course 2, patients receive trastuzumab and paclitaxel as in course 1 and interleukin-12 subcutaneously on days 2, 5, 9, 12, 16, and 19. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

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

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed HER2/neu-overexpressing (2+ or 3+) malignancy by any standardized assay (fluorescence in-situ hybridization allowed)
  • Measurable or evaluable disease
  • Failed standard curative therapy
  • No brain or CNS metastasis
  • Hormone receptor status:

    • Not specified
  • Male or female
  • Performance status - Karnofsky 70-100%
  • At least 6 months
  • Absolute neutrophil count at least 1,500/mm^3
  • Hemoglobin at least 8 g/dL (transfusion or epoetin alfa allowed)
  • Platelet count at least 100,000/mm^3
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST and ALT no greater than 3.0 times ULN
  • Hepatitis B surface antigen negative
  • Creatinine no greater than 1.5 times ULN
  • Calcium no greater than 11 mg/dL (calcium-lowering agents allowed)
  • No active or unstable cardiovascular disease
  • No cardiac disease requiring drug or device intervention
  • No coronary artery disease
  • No congestive heart failure
  • Cardiac ejection fraction normal by echocardiogram or MUGA scan
  • No significant peripheral neuropathy
  • No significant CNS disease
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No serious concurrent infection requiring IV antibiotic therapy
  • No clinically significant autoimmune disease (e.g., rheumatoid arthritis)
  • No clinically significant gastrointestinal bleeding
  • No uncontrolled peptic ulcer disease
  • No inflammatory bowel disease
  • No other major illness that would preclude study participation
  • No other concurrent malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix
  • No prior interleukin-12
  • No prior trastuzumab (Herceptin®)
  • At least 3 weeks since prior chemotherapy
  • At least 3 weeks since prior hormonal therapy
  • No concurrent systemic corticosteroids
  • At least 3 weeks since prior radiotherapy
  • At least 3 weeks since prior surgery
  • At least 3 weeks since prior investigational drug
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Please refer to this study by its identifier: NCT00028535

United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: William Carson Ohio State University
  More Information

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00028535     History of Changes
Other Study ID Numbers: NCI-2012-01407
U01CA076576 ( US NIH Grant/Contract Award Number )
Study First Received: January 4, 2002
Last Updated: June 3, 2013

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Stomach Neoplasms
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Breast Neoplasms, Male
Endometrial Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female processed this record on May 25, 2017