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| Descriptive Information Fields | |||||
| Brief Title † | Interleukin-2 and Interleukin-12 in Treating Patients With Refractory or Advanced Solid Tumors | ||||
| Official Title † | A Phase I Investigation of IL-12/Pulse IL-2 in Adults With Advanced Solid Tumors | ||||
| Brief Summary | RATIONALE: Interleukin-2 may stimulate a person's lymphocytes to kill solid tumor cells. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill solid tumor cells. Combining interleukin-2 with interleukin-12 may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-2 and interleukin-12 in treating patients with refractory or advanced solid tumors. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Cohorts of 3-6 patients receive escalating doses of interleukin-12 and interleukin-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 3 weeks. PROJECTED ACCRUAL: A total of 24-34 patients will be accrued for part I and total of 10 patients will be accrued part II of the study within approximately 2 years. |
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| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Breast Cancer Kidney Cancer Lung Cancer Ovarian Cancer Sarcoma Unspecified Adult Solid Tumor, Protocol Specific |
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| Intervention † | Drug: aldesleukin Drug: recombinant interleukin-12 |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | |||||
| Start Date † | June 2000 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00020163 | ||||
| Organization ID | CDR0000067889 | ||||
| Secondary IDs †† | NCI-00-C-0121, NCI-41 | ||||
| Study Sponsor † | NCI - Center for Cancer Research-Medical Oncology | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | February 2007 | ||||
| First Received Date † | July 11, 2001 | ||||
| Last Updated Date | October 18, 2008 | ||||