Phase I Trial of Interleukin-12 Followed by Interferon-Alpha
recombinant interferon alfa
+ recombinant interleukin-12
Lymphadenopathy+80
+ Amyloidosis
+ Blood Coagulation Disorders
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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