Completed

Phase I Trial of Interleukin-12 Followed by Interferon-Alpha

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What is being tested

recombinant interferon alfa

+ recombinant interleukin-12

Biological
Who is being recruted

Lymphadenopathy+80

+ Amyloidosis

+ Blood Coagulation Disorders

Over 13 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: August 1998
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: February 1, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 1998

Actual date on which the first participant was enrolled.

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.

NCT00003451
Principal SponsorNational Cancer Institute (NCI)
Last updated: February 1, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 13 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

LymphadenopathyAmyloidosisBlood Coagulation DisordersBlood Platelet DisordersBlood Protein DisordersBone Marrow DiseasesCardiovascular DiseasesCell Transformation, NeoplasticChronic DiseaseDNA Virus InfectionsHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersHerpesviridae InfectionsHypergammaglobulinemiaImmune System DiseasesImmunoproliferative DisordersInfectionsLeukemia, LymphoidLeukemia, MyeloidLymphatic DiseasesLymphoproliferative DisordersMetabolic DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplastic ProcessesNutritional and Metabolic DiseasesParaproteinemiasPathologic ProcessesPathological Conditions, Signs and SymptomsThrombocytosisTumor Virus InfectionsVascular DiseasesVirus DiseasesLeukemia, B-CellLeukemia, T-CellLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLymphoma, B-CellLymphoma, T-CellBone Marrow NeoplasmsHematologic NeoplasmsEpstein-Barr Virus InfectionsHemostatic DisordersDisease AttributesMyelodysplastic-Myeloproliferative DiseasesProteostasis DeficienciesCarcinogenesisImmunoglobulin Light-chain AmyloidosisBlast CrisisBurkitt LymphomaHodgkin DiseaseImmunoblastic LymphadenopathyLeukemiaLeukemia, Hairy CellLymphomaLymphoma, FollicularLymphoma, Non-HodgkinWaldenstrom MacroglobulinemiaMonoclonal Gammopathy of Undetermined SignificanceMultiple MyelomaMyelodysplastic SyndromesMyeloproliferative DisordersPolycythemia VeraPrecancerous ConditionsThrombocythemia, EssentialLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Biphenotypic, AcuteLeukemia, ProlymphocyticLeukemia, Myeloid, Accelerated PhaseLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, AcuteLeukemia, Myelomonocytic, ChronicLymphoma, Large-Cell, ImmunoblasticLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, AnaplasticLymphoma, B-Cell, Marginal ZoneLymphoma, Mantle-CellLeukemia, Large Granular LymphocyticPrecursor Cell Lymphoblastic Leukemia-LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaNeoplasms, Plasma CellPrimary Myelofibrosis

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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 Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, United StatesOpen Arthur G. James Cancer Hospital - Ohio State University in Google Maps
CompletedOne Study Center