Interleukin-12 in Treating Patients With Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003330
Recruitment Status : Completed
First Posted : May 20, 2004
Last Update Posted : February 11, 2013
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
Phase I trial to study the effectiveness of interleukin-12 in treating patients who have advanced cancer. 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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Biological: recombinant interleukin-12 Phase 1

Detailed Description:


I. Determine the toxicity profile and maximum tolerated dose (MTD) of intravenous interleukin-12 (IL-12) administered biweekly for 6-18 weeks in the presence and absence of a test dose in patients with metastatic or unresectable malignancies.

II. Determine the optimal timing for administration of an IL-12 test dose, based on its impact on secondary biologic parameters in these patients.

III. Determine the antitumor effects of IL-12 administered according to this schedule, with and without a test dose, in these patients.

IV. Determine the effect of a test dose on toxicity profile, MTD, tumor response and various biologic phenomena in serum, and, where possible, tumor and liver in these patients.

OUTLINE: This is a 3-part dose escalation study.

In Part A, patients receive intravenous interleukin-12 (IL-12) twice a week for 6 weeks. Courses are repeated until patients achieve a complete response or there is disease progression. Dose escalation of IL-12 continues in cohorts of 3-6 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose below that at which 2 of 6 patients experience dose limiting toxicity (DLT).

In Part B, patients receive a single test dose of IL-12 administered intravenously at a 1, 2, or 3 week interval prior to starting the multidose twice a week regimen as in Part A. Cohorts of 4 patients will receive IL-12 at the MTD obtained in Part A.

In Part C, patients receive IL-12 at one dose level above the MTD obtained in Part A using the optimal schedule for the test dose determined in Part B. Dose escalation continues in cohorts of 3-6 patients until the MTD is determined. The MTD is defined as the dose below that at which 2 of 6 patients experience DLT. Patients may continue to receive IL-12 until they have no measurable disease or until disease progression.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Clinical Trials of IV rhIL-12 With or Without a Test-Dose in Patients With Advanced Malignancies (rhIL-12 NSC# 672423)
Study Start Date : July 1998
Actual Primary Completion Date : April 2002

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm I
See detailed description.
Biological: recombinant interleukin-12

Information from the National Library of Medicine

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


  • Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
  • Advanced measurable or evaluable disease that is clearly progressive
  • No brain metastases


  • Age: 18 and over
  • Performance status: ECOG 0-1 Karnofsky 80-100%
  • Life expectancy: At least 3 months
  • WBC greater than 4,000/mm3
  • Platelet count greater than 100,000/mm3
  • Bilirubin less than 1.5 mg/dL
  • SGOT/SGPT less than 2 times normal
  • Creatinine less than 1.5 mg/dL
  • Creatinine clearance at least 60 mL/min
  • No congestive heart failure
  • No coronary artery disease
  • No serious cardiac arrhythmias
  • No evidence of prior myocardial infarction on EKG
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Not HIV positive
  • No seizure disorders
  • No active infection that requires antibiotic therapy
  • No significant medical disease other than the malignancy


  • No more than 2 prior biological response modifier treatment regimen
  • No immunotherapy within the past 4 weeks
  • No prior interleukin-12
  • No more than 2 prior chemotherapy regimens
  • At least 4 weeks since chemotherapy and recovered
  • At least 6 weeks since nitrosoureas or mitomycin and recovered
  • No concurrent chemotherapy
  • At least 4 weeks since hormone therapy and recovered
  • No concurrent hormone therapy
  • No concurrent corticosteroids
  • At least 4 weeks since radiotherapy and recovered
  • No concurrent radiotherapy
  • No organ allografts
  • At least 2 weeks since intravenous antibiotics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003330

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
National Cancer Institute (NCI)
Study Chair: Michael B. Atkins, MD Beth Israel Deaconess Medical Center

Publications of Results:
Responsible Party: National Cancer Institute (NCI) Identifier: NCT00003330     History of Changes
Other Study ID Numbers: CDR0000066286
First Posted: May 20, 2004    Key Record Dates
Last Update Posted: February 11, 2013
Last Verified: May 2001

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents