Interleukin-12 in Treating Patients With Advanced Cancer

This study has been completed.
Information provided by (Responsible Party):
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: February 8, 2013
Last verified: May 2001

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 Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
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 Clinical Trials of IV rhIL-12 With or Without a Test-Dose in Patients With Advanced Malignancies (rhIL-12 NSC# 672423)

Resource links provided by NLM:

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

Enrollment: 54
Study Start Date: July 1998
Primary Completion Date: April 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
See detailed description.
Biological: recombinant interleukin-12

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: NCT00003330

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Study Chair: Michael B. Atkins, MD Beth Israel Deaconess Medical Center
  More Information

Additional Information:
Responsible Party: National Cancer Institute (NCI) Identifier: NCT00003330     History of Changes
Other Study ID Numbers: CDR0000066286, BIH-97-1083, NCI-T97-0053
Study First Received: November 1, 1999
Last Updated: February 8, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Adjuvants, Immunologic
Immunologic Factors processed this record on April 17, 2014