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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00276835 |
RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Interleukin-2 may stimulate the white blood cells, including natural killer cells, to kill melanoma or kidney cancer cells. Giving genistein together with interleukin-2 may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving genistein together with interleukin-2 works in treating patients with metastatic melanoma or kidney cancer.
Condition | Intervention | Phase |
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Kidney Cancer Melanoma (Skin) |
Drug: aldesleukin Drug: genistein |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Pilot Study of the Effect of Genistein in Combination With High-Dose Interleukin-2 on Cell Expansion and Gene Expression in Patients With Metastatic Melanoma or Renal Cell Carcinoma |
Estimated Enrollment: | 15 |
Study Start Date: | November 2005 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot study.
Patients receive high-dose interleukin-2 IV over 15 minutes twice daily on days 1 and 15 and 3 times daily on days 2-5 and 16-19. Patients also receive oral genistein twice daily on days 10-19.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Documented histologically confirmed malignant melanoma or renal clear cell carcinoma
At least 1 measurable lesion that can be accurately measured in at least one dimension with longest diameter > 20 mm using conventional techniques OR > 10 mm with spiral CT scan
The following are considered non-measurable lesions:
PATIENT CHARACTERISTICS:
Adequate pulmonary reserve
PRIOR CONCURRENT THERAPY:
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
Chicago, Illinois, United States, 60611-3013 |
Study Chair: | Timothy M. Kuzel, MD | Robert H. Lurie Cancer Center |
Study ID Numbers: | CDR0000456376, NU-04V1, CHIR-NU-04V1, NU-IRB-0310-083 |
Study First Received: | January 12, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00276835 |
Health Authority: | United States: Food and Drug Administration |
recurrent renal cell cancer clear cell renal cell carcinoma stage IV renal cell cancer recurrent melanoma stage IV melanoma |
Urogenital Neoplasms Renal cancer Kidney cancer Urologic Neoplasms Recurrence Melanoma Carcinoma Neuroendocrine Tumors Neuroectodermal Tumors Aldesleukin Urologic Diseases Interleukin-2 |
Kidney Neoplasms Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Carcinoma, Renal Cell Neuroepithelioma Nevus Kidney Diseases Clear cell renal cell carcinoma Adenocarcinoma Genistein Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Anticarcinogenic Agents Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Protein Kinase Inhibitors Neoplasms by Site Anti-Retroviral Agents Sensory System Agents Therapeutic Uses Phytoestrogens |
Nevi and Melanomas Analgesics Estrogens Neoplasms by Histologic Type Anti-HIV Agents Enzyme Inhibitors Antiviral Agents Protective Agents Pharmacologic Actions Neoplasms Analgesics, Non-Narcotic Estrogens, Non-Steroidal Peripheral Nervous System Agents Central Nervous System Agents |