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| Sponsored by: |
National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00492440 |
Purpose
RATIONALE: Interleukin-7 may stimulate the white blood cells to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-7 in treating patients with metastatic melanoma or locally advanced or metastatic kidney cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer Melanoma (Skin) |
Biological: recombinant interleukin-7 Genetic: gene expression analysis Genetic: polymerase chain reaction Genetic: protein expression analysis Other: flow cytometry Other: immunoenzyme technique Other: immunologic technique Other: laboratory biomarker analysis Other: pharmacological study |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Study of Subcutaneous "CYT 107" (Interleukin-7) in Refractory Metastatic Melanoma or Renal Cell Carcinoma |
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2007 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study. Patients are stratified according to lymphocyte count (normal lymphocyte count [CD4+ T cells > 400/mm^3] vs lymphopenic [CD4+ T cells < 400/mm^3]). Patients are assigned to 1 of 2 treatment groups.
Patients undergo blood and bone marrow collection periodically for pharmacokinetic, pharmacodynamic, and immunological studies. Samples are analyzed for the presence of antibodies and proteins via ELISA; CD3, CD4, and CD8 T cell counts, CD127, Ki-67, and Bcl-2 expression in CD4+ and CD8+ T cells, and CD19 B cell counts via flow cytometry; and clonal B cell proliferation via PCR and flow cytometry.
After completion of study treatment, patients are followed at 3 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Melanoma
Renal cell carcinoma
PATIENT CHARACTERISTICS:
LVEF ≥ 45% by cardiac stress test (e.g., stress thallium, stress MUGA, dobutamine echocardiogram, or other stress test) for patients meeting any of the following criteria:
No acute hepatitis A or hepatitis B or C
Resting blood pressure ≤ 140/90 mm Hg on standard antihypertensive therapy
No active infection requiring systemic treatment and/or hospitalization within the past 28 days
PRIOR CONCURRENT THERAPY:
No concurrent chronic anticoagulation (i.e., high-dose warfarin or heparin)
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
| Bethesda, Maryland, United States, 20892-1182 | |
| Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |
| Study Chair: | Steven A. Rosenberg, MD, PhD | NCI - Surgery Branch |
More Information
| Study ID Numbers: | CDR0000551550, NCI-07-C-0114, CYTHERIS-CLI-107-04 |
| Study First Received: | June 25, 2007 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00492440 History of Changes |
| Health Authority: | Unspecified |
|
recurrent renal cell cancer stage IV renal cell cancer stage III renal cell cancer recurrent melanoma stage IV melanoma |
|
Urinary Tract Neoplasm Kidney Cancer Urogenital Neoplasms Urologic Neoplasms Recurrence Melanoma Carcinoma Neuroendocrine Tumors Neuroectodermal Tumors Renal Cancer |
Urologic Diseases Kidney Neoplasms Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Carcinoma, Renal Cell Neuroepithelioma Nevus Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
|
Neoplasms by Histologic Type Neoplasms, Nerve Tissue Urogenital Neoplasms Urologic Neoplasms Neuroendocrine Tumors Melanoma Carcinoma Neuroectodermal Tumors Neoplasms |
Neoplasms by Site Urologic Diseases Kidney Neoplasms Neoplasms, Germ Cell and Embryonal Carcinoma, Renal Cell Nevi and Melanomas Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |