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Sponsors and Collaborators: |
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003451 |
RATIONALE: 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.
PURPOSE: 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.
Condition | Intervention | Phase |
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Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Precancerous/Nonmalignant Condition Unspecified Adult Solid Tumor, Protocol Specific |
Biological: recombinant interferon alfa Biological: recombinant interleukin-12 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Trial of Interleukin-12 Followed by Interferon-Alpha |
Estimated Enrollment: | 40 |
Study Start Date: | August 1998 |
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.
PROJECTED ACCRUAL: Approximately 30-40 patients will be accrued into this study.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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 Hematopoietic: 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) Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT and SGPT no greater than 2 times ULN Renal: 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) Cardiovascular: No significant cardiovascular disease No cardiac arrhythmia requiring drug or device intervention Neurological: No history of significant peripheral neuropathy No significant central nervous system disease Other: 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: Biologic therapy: At least 4 weeks since prior biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: No concurrent systemic corticosteroids Radiotherapy: At least 2 weeks since prior local radiotherapy Surgery: At least 2 weeks since surgery Other: At least 4 weeks since prior investigational drug
United States, Ohio | |
Arthur G. James Cancer Hospital - Ohio State University | |
Columbus, Ohio, United States, 43210 |
Study Chair: | William E. Carson, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Study ID Numbers: | CDR0000066482, OSU-T98-0020, NCI-T98-0020 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003451 History of Changes |
Health Authority: | United States: Federal Government |
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 Waldenstrom 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 chronic idiopathic myelofibrosis essential thrombocythemia untreated hairy cell leukemia progressive hairy cell leukemia, initial treatment refractory hairy cell leukemia chronic myelomonocytic leukemia |
Polycythemia Anti-Infective Agents Chronic Myelomonocytic Leukemia Blast Crisis Large Granular Lymphocyte Leukemia Lymphoma, Mantle-Cell Mantle Cell Lymphoma Follicular Lymphoma Acute Myelocytic Leukemia Preleukemia Hemorrhagic Disorders Leukemia, Prolymphocytic Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell Neoplasm Metastasis |
Lymphoma, Large-Cell, Anaplastic Thrombocythemia, Hemorrhagic Hodgkin Disease Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Blood Coagulation Disorders Leukemia, Myelomonocytic, Chronic Hairy Cell Leukemia Adjuvants, Immunologic Myeloproliferative Disorders Leukemia, Myeloid Multiple Myeloma Waldenstrom Macroglobulinemia |
Anti-Infective Agents Interferon Type I, Recombinant Interleukin-12 Immunologic Factors Precancerous Conditions Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Hemostatic Disorders Leukemia Preleukemia Pathologic Processes Hemorrhagic Disorders Therapeutic Uses |
Syndrome Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents Lymphoma Interferon-alpha Neoplasms by Histologic Type Immunoproliferative Disorders Disease Immune System Diseases Hematologic Diseases Growth Substances Interferons Myelodysplastic Syndromes Adjuvants, Immunologic |