Interleukin-12 in Treating Patients With Hematologic Cancers or Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00003107|
Recruitment Status : Completed
First Posted : April 6, 2004
Last Update Posted : September 10, 2014
RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells.
PURPOSE: Phase I trial to study the effectiveness of interleukin-12 in treating patients who have hematologic cancer or solid tumor.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Chronic Myeloproliferative Disorders Gestational Trophoblastic Tumor Kidney Cancer Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Neuroblastoma Ovarian Cancer Testicular Germ Cell Tumor||Biological: recombinant interleukin-12||Phase 1|
OBJECTIVES: I. Assess the safety and maximum tolerated dose of interleukin-12 (IL-12) in patients with hematologic malignancies or solid tumors who have undergone high-dose chemotherapy and autologous stem cell transplantation. II. Evaluate the hematologic and immunologic effects of IL-12 in these patients.
OUTLINE: This is a dose-escalation study. Patients receive interleukin-12 (IL-12) IV as a single test dose followed by 2 weeks of rest. Patients then receive IL-12 IV daily for 5 days followed by 16 days of rest for up to 6 courses. Cohorts of 3-5 patients receive escalating doses of IL-12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 patients experience dose-limiting toxicity. Patients are followed until death.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase I Trial of Recombinant Human Interleukin-12 After High-Dose Therapy and Autologous Hematopoietic Stem Cell Support|
|Study Start Date :||October 1997|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003107
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202-5265|
|Study Chair:||Michael J. Robertson, MD||Indiana University Melvin and Bren Simon Cancer Center|