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Interleukin-12 Followed by Interferon Alfa 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.
 
ClinicalTrials.gov Identifier: NCT00003451
Recruitment Status : Completed
First Posted : September 13, 2004
Last Update Posted : February 1, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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Brief Summary:
Phase I trial to study the effectiveness of combining interleukin-12 and interferon alfa in treating patients who have residual, recurrent, or metastatic malignant melanoma or other advanced cancer that has not responded to standard therapy. Interleukin-12 may stimulate a person's white blood cells to kill cancer cells. Interferon alfa may interfere with the growth of the cancer cells. Combining interleukin-12 with interferon alfa may kill more cancer cells.

Condition or disease Intervention/treatment Phase
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Precancerous Condition Unspecified Adult Solid Tumor, Protocol Specific Biological: recombinant interferon alfa Biological: recombinant interleukin-12 Phase 1

Detailed Description:

OBJECTIVES:

I. Determine the maximum tolerated dose of interferon alfa when preceded by a single dose of interleukin-12 in patients with recurrent or metastatic melanoma or other advanced malignancies.

OUTLINE: This is a dose-escalation study.

Cohorts of 3 patients receive interleukin-12 IV push on day 1, followed by escalating doses of interferon alfa by subcutaneous injection at 24, 48, 72, 96 and 120 hours. Courses repeat every 2 weeks for 6 months (12 courses total) in the absence of unacceptable toxicity and disease progression. Patients achieving partial response or stable disease at the completion of 6 months of therapy may receive additional courses of therapy for up to 24 months. Dose escalation of interferon alfa continues in subsequent cohorts in the absence of dose limiting toxicity (DLT). If 1 of 3 patients experiences DLT at a dose level, then 3 additional patients are entered at that dose level. If 2 of 6 patients experience DLT, then dose escalation stops. The maximum tolerated dose is defined as 1 level below that dose at which 2 or more of 6 patients experience DLT. Patients are followed every 3 months for 1 year and then every 6 months thereafter.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of Interleukin-12 Followed by Interferon-Alpha
Study Start Date : August 1998
Actual Primary Completion Date : December 2001

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Multiple Myeloma Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Myelodysplastic Syndromes Lymphosarcoma Follicular Lymphoma Chronic Myeloid Leukemia Primary Myelofibrosis Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia B-cell Lymphoma Diffuse Large B-Cell Lymphoma Chronic Lymphocytic Leukemia Mantle Cell Lymphoma Leukemia, T-cell, Chronic Adult T-cell Leukemia/lymphoma Waldenstrom Macroglobulinemia Monoclonal Gammopathy of Undetermined Significance Hodgkin Lymphoma Hairy Cell Leukemia Marginal Zone Lymphoma Polycythemia Vera Essential Thrombocythemia Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Chronic Myeloproliferative Disorders Plasmacytoma AL Amyloidosis Burkitt Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Aggressive NK Cell Leukemia T-cell Large Granular Lymphocyte Leukemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I
Cohorts of 3 patients receive interleukin-12 IV push on day 1, followed by escalating doses of interferon alfa by subcutaneous injection at 24, 48, 72, 96 and 120 hours. Courses repeat every 2 weeks for 6 months (12 courses total) in the absence of unacceptable toxicity and disease progression. Patients achieving partial response or stable disease at the completion of 6 months of therapy may receive additional courses of therapy for up to 24 months. Dose escalation of interferon alfa continues in subsequent cohorts in the absence of dose limiting toxicity (DLT). If 1 of 3 patients experiences DLT at a dose level, then 3 additional patients are entered at that dose level. If 2 of 6 patients experience DLT, then dose escalation stops. The maximum tolerated dose is defined as 1 level below that dose at which 2 or more of 6 patients experience DLT. Patients are followed every 3 months for 1 year and then every 6 months thereafter.
 Biological: recombinant interferon alfa
Biological: recombinant interleukin-12


Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed residual, recurrent, or metastatic malignant melanoma or other advanced malignancies
  • Must have failed standard curative and/or palliative therapies
  • No brain or central nervous system metastases

PATIENT CHARACTERISTICS:

  • Age: 13 and over
  • Performance status: Karnofsky 70-100%
  • Life expectancy: At least 12 weeks
  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL (may be posttransfusion or may receive erythropoietin)
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT and SGPT no greater than 2 times ULN
  • Creatinine no greater than 1.5 times ULN
  • Creatinine clearance at least 60 mL/min
  • Calcium no greater than 11 mg/dL (may receive agents to decrease calcium)
  • No significant cardiovascular disease
  • No cardiac arrhythmia requiring drug or device intervention
  • No history of significant peripheral neuropathy
  • No significant central nervous system disease
  • HIV negative Hepatitis B surface antigen negative
  • No concurrent serious infection requiring intravenous antibiotic therapy
  • No clinically significant autoimmune disease (i.e., rheumatoid arthritis)
  • No clinically significant gastrointestinal bleeding or uncontrolled peptic ulcer disease
  • No history of inflammatory bowel disease
  • No other major illness that substantially increases the risk associated with participation in this study
  • Not pregnant or nursing Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY:

  • At least 4 weeks since prior biologic therapy
  • At least 4 weeks since prior chemotherapy
  • No concurrent systemic corticosteroids
  • At least 2 weeks since prior local radiotherapy
  • At least 2 weeks since surgery Other: At least 4 weeks since prior investigational drug
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00003451


Locations
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United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Study Chair: William E. Carson, MD Ohio State University Comprehensive Cancer Center
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003451    
Other Study ID Numbers: NCI-2012-01397
OSU-T98-0020
NCI-T98-0020
CDR0000066482 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: September 13, 2004    Key Record Dates
Last Update Posted: February 1, 2013
Last Verified: July 2007
Keywords provided by National Cancer Institute (NCI):
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
monoclonal gammopathy of undetermined significance
recurrent adult Hodgkin lymphoma
isolated plasmacytoma of bone
extramedullary plasmacytoma
refractory multiple myeloma
Waldenström macroglobulinemia
stage III multiple myeloma
stage IV chronic lymphocytic leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
unspecified adult solid tumor, protocol specific
 chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
untreated adult acute lymphoblastic leukemia
untreated adult acute myeloid leukemia
adult acute myeloid leukemia in remission
adult acute lymphoblastic leukemia in remission
polycythemia vera
primary myelofibrosis
essential thrombocythemia
untreated hairy cell leukemia
progressive hairy cell leukemia, initial treatment
refractory hairy cell leukemia
chronic myelomonocytic leukemia
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Preleukemia
Precancerous Conditions
Myelodysplastic Syndromes
Myeloproliferative Disorders
Syndrome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Disease
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Interferons
Interferon-alpha
Interleukin-12
Antineoplastic Agents
Antiviral Agents