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| Sponsor: | Cytheris SA |
|---|---|
| Collaborator: |
Cytheris, Inc. |
| Information provided by: | Cytheris SA |
| 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: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: 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 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
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.
Cohorts of 3-6 patients from each group receive escalating doses of recombinant IL-7 until the maximum tolerated dose (MTD) is determined. The MTD is the defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 30 additional patients may be treated at the MTD.
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
| Responsible Party: | Michel Morre, Cytheris |
| ClinicalTrials.gov Identifier: | NCT00492440 History of Changes |
| Other Study ID Numbers: | CLI-107-04, NCI-07-C-0114, CYTHERIS-CLI-107-04 |
| Study First Received: | June 25, 2007 |
| Last Updated: | December 4, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent renal cell cancer stage IV renal cell cancer stage III renal cell cancer recurrent melanoma stage IV melanoma |
|
Carcinoma, Renal Cell Kidney Neoplasms Melanoma Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms |
Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nevi and Melanomas |