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Interleukin-12 in Treating Patients With Advanced Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003330
First Posted: May 20, 2004
Last Update Posted: February 11, 2013
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.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
November 1, 1999
May 20, 2004
February 11, 2013
July 1998
April 2002   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003330 on ClinicalTrials.gov Archive Site
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Interleukin-12 in Treating Patients With Advanced Cancer
Phase I Clinical Trials of IV rhIL-12 With or Without a Test-Dose in Patients With Advanced Malignancies (rhIL-12 NSC# 672423)
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.

OBJECTIVES:

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Biological: recombinant interleukin-12
Experimental: Arm I
See detailed description.
Intervention: Biological: recombinant interleukin-12

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
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April 2002   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00003330
CDR0000066286
BIH-97-1083
NCI-T97-0053
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National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Study Chair: Michael B. Atkins, MD Beth Israel Deaconess Medical Center
National Cancer Institute (NCI)
May 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP