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| Sponsored by: |
National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00020163 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Kidney Cancer Lung Cancer Ovarian Cancer Sarcoma Unspecified Adult Solid Tumor, Protocol Specific |
Biological: aldesleukin Biological: recombinant interleukin-12 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Investigation of IL-12/Pulse IL-2 in Adults With Advanced Solid Tumors |
| Study Start Date: | June 2000 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Treatment continues every 35 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed refractory or advanced nonhematologic malignancy (e.g., breast, lung, or renal cell cancer or sarcoma) for which no curative therapy exists
Hormone receptor status:
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:
Contacts and Locations| United States, Maryland | |
| NCI - Center for Cancer Research | |
| Bethesda, Maryland, United States, 20892 | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | John E. Janik, MD | NCI - Metabolism Branch;MET |
More Information
| Study ID Numbers: | CDR0000067889, NCI-00-C-0121, NCI-41 |
| Study First Received: | July 11, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00020163 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer recurrent breast cancer metastatic osteosarcoma recurrent non-small cell lung cancer chondrosarcoma recurrent adult soft tissue sarcoma stage IV renal cell cancer recurrent renal cell cancer extensive stage small cell lung cancer recurrent small cell lung cancer recurrent osteosarcoma stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
unspecified adult solid tumor, protocol specific classic Kaposi sarcoma immunosuppressive treatment related Kaposi sarcoma AIDS-related Kaposi sarcoma recurrent Kaposi sarcoma pulmonary carcinoid tumor stage IV uterine sarcoma recurrent uterine sarcoma ovarian sarcoma metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor clear cell sarcoma of the kidney stage IV adult soft tissue sarcoma |
|
Thoracic Neoplasms Neuroectodermal Tumors, Primitive Urogenital Neoplasms Urologic Neoplasms Kaposi Sarcoma Neoplasms, Connective and Soft Tissue Lung Neoplasms Ovarian Cancer Neuroepithelioma Osteogenic Sarcoma Kidney Diseases Breast Diseases Endocrine Gland Neoplasms Anti-HIV Agents Adjuvants, Immunologic |
Genital Neoplasms, Female Sarcoma, Clear Cell Breast Neoplasms Endocrine System Diseases Ewing's Sarcoma Carcinoma Carcinoma, Small Cell Neuroectodermal Tumors Malignant Mesenchymal Tumor Aldesleukin Lung Diseases Uterine Sarcoma Sarcoma Carcinoid Tumor Carcinoma, Non-Small-Cell Lung |
|
Thoracic Neoplasms Anti-Infective Agents Interleukin-12 Immunologic Factors Antineoplastic Agents Gonadal Disorders Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Urologic Neoplasms Genital Diseases, Female Neoplasms, Connective and Soft Tissue Neoplasms by Site Anti-Retroviral Agents Urologic Diseases |
Respiratory Tract Diseases Lung Neoplasms Kidney Neoplasms Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Kidney Diseases Breast Diseases Endocrine Gland Neoplasms Respiratory Tract Neoplasms Anti-HIV Agents Ovarian Neoplasms Neoplasms by Histologic Type Skin Diseases Growth Substances |