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Interleukin-12 Followed by Interferon Alfa in Treating Patients With Advanced Cancer
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003451
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 40
Study Start Date: August 1998
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.

PROJECTED ACCRUAL: Approximately 30-40 patients will be accrued into this study.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
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 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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003451

Locations
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Investigators
Study Chair: William E. Carson, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
  More Information

Additional Information:
No publications provided

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

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
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 01, 2009