Interleukin-12 Followed by Interferon Alfa in Treating Patients With Advanced Cancer

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.

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Key information

Conditions

Chronic Myeloproliferative Disorders Amyloidosis Blast Crisis Blood Coagulation Disorders Blood Platelet Disorders Blood Protein Disorders Bone Marrow Diseases Bone Marrow Neoplasms Burkitt Lymphoma Carcinogenesis Cardiovascular Diseases Cell Transformation, Neoplastic Chronic Disease DNA Virus Infections Disease Attributes Epstein-Barr Virus Infections Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Hodgkin Disease Hypergammaglobulinemia Immune System Diseases Immunoblastic Lymphadenopathy Immunoglobulin Light-chain Amyloidosis Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Biphenotypic, Acute Leukemia, Hairy Cell Leukemia, Large Granular Lymphocytic Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic-Phase Leukemia, Myelomonocytic, Chronic Leukemia, Prolymphocytic Leukemia, T-Cell Lymphadenopathy Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Anaplastic Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Metabolic Diseases Monoclonal Gammopathy of Undetermined Significance Multiple Myeloma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Neoplastic Processes Nutritional and Metabolic Diseases Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Polycythemia Vera Precancerous Condition Precancerous Conditions Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Primary Myelofibrosis Proteostasis Deficiencies Thrombocythemia, Essential Thrombocytosis Tumor Virus Infections Unspecified Adult Solid Tumor, Protocol Specific Vascular Diseases Virus Diseases Waldenstrom Macroglobulinemia

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

recombinant interferon alfa

Biological

recombinant interleukin-12

Biological

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

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

Important dates

Study start: 1998
Primary completion: 2001
First posted: Sep 13, 2004
Registry last updated: Feb 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed