- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003451
Interleukin-12 Followed by Interferon Alfa in Treating Patients With Advanced Cancer
Phase I Trial of Interleukin-12 Followed by Interferon-Alpha
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- Arthur G. James Cancer Hospital - Ohio State University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: William E. Carson, MD, Ohio State University Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- unspecified adult solid tumor, protocol specific
- primary myelofibrosis
- stage III adult diffuse large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult Burkitt lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult Burkitt lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult Burkitt lymphoma
- chronic myelomonocytic leukemia
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- secondary acute myeloid leukemia
- chronic phase chronic myelogenous leukemia
- childhood myelodysplastic syndromes
- primary systemic amyloidosis
- recurrent adult acute myeloid leukemia
- untreated adult acute myeloid leukemia
- adult acute myeloid leukemia in remission
- recurrent adult Hodgkin lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- blastic phase chronic myelogenous leukemia
- relapsing chronic myelogenous leukemia
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- stage III multiple myeloma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent mantle cell lymphoma
- refractory chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- stage III adult lymphoblastic lymphoma
- stage IV adult lymphoblastic lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage IV adult T-cell leukemia/lymphoma
- recurrent adult T-cell leukemia/lymphoma
- angioimmunoblastic T-cell lymphoma
- anaplastic large cell lymphoma
- refractory multiple myeloma
- recurrent adult acute lymphoblastic leukemia
- polycythemia vera
- essential thrombocythemia
- refractory hairy cell leukemia
- prolymphocytic leukemia
- Waldenström macroglobulinemia
- monoclonal gammopathy of undetermined significance
- accelerated phase chronic myelogenous leukemia
- adult acute lymphoblastic leukemia in remission
- isolated plasmacytoma of bone
- extramedullary plasmacytoma
- acute undifferentiated leukemia
- untreated adult acute lymphoblastic leukemia
- meningeal chronic myelogenous leukemia
- progressive hairy cell leukemia, initial treatment
- T-cell large granular lymphocyte leukemia
- untreated hairy cell leukemia
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Lymphoma
- Syndrome
- Myelodysplastic Syndromes
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Leukemia
- Preleukemia
- Plasmacytoma
- Myeloproliferative Disorders
- Precancerous Conditions
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Adjuvants, Immunologic
- Interferons
- Interferon-alpha
- Interleukin-12
Other Study ID Numbers
- NCI-2012-01397
- OSU-T98-0020
- NCI-T98-0020
- CDR0000066482 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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