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Interleukin-12 in Treating Patients With Advanced Cancer

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00003330
Collaborator
(none)
54
Enrollment
1
Location
1
Arm

Study Details

Study Description

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
  • Biological: recombinant interleukin-12
 Phase 1

Detailed Description

OBJECTIVES:

  1. 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.

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

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

  4. 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 Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
N/A
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 :
Jul 1, 1998
Actual Primary Completion Date :
Apr 1, 2002

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I

See detailed description.

Biological: recombinant interleukin-12

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Michael B. Atkins, MD, Beth Israel Deaconess Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00003330
    Other Study ID Numbers:
    • CDR0000066286
    • BIH-97-1083
    • NCI-T97-0053
    First Posted:
    May 20, 2004
    Last Update Posted:
    Feb 11, 2013
    Last Verified:
    May 1, 2001
    Keywords provided by National Cancer Institute (NCI)
    unspecified adult solid tumor, protocol specific
    Additional relevant MeSH terms:
    Interleukin-12

    Study Results

    No Results Posted as of Feb 11, 2013