The High-Dose Aldesleukin (IL-2) "Select" Trial for Patients With Metastatic Renal Cell Carcinoma (SELECT)
Recruitment status was Active, not recruiting
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Purpose
High-dose interleukin 2 (Proleukin, Novartis) (IL-2) is approved by the U.S Food and Drug Administration (FDA) for the treatment of metastatic kidney cancer and is a standard treatment of this disease. At the present time, IL-2 is the only therapy for kidney cancer that can produce a remission of disease that lasts after treatment is completed. However, most patients who receive IL-2 do not benefit and all patients experience potentially dangerous side effects.
Recent research has suggested that certain patients may respond better to IL-2 than others. The Cytokine Working Group is currently conducting a clinical trial that aims to identify and confirm this research and narrow the application of IL-2 to those patients most likely to benefit. This trial is being conducted at 14 treatment centers in the Untied States that specialize in giving IL-2. All patients who are eligible for enrollment in the study will receive the FDA approved regimen of high-dose IL-2. To identify markers that may predict response to IL-2, patients are asked to provide a piece of their original tumor for research. They are not required to have a separate tumor biopsy. Blood samples (2-3 tablespoons) for research will also be drawn prior to treatment and tumor measurements will be obtained before and after treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Renal Cell Carcinoma |
Drug: aldesleukin (Proleukin) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The High-Dose Aldesleukin (IL-2) "Select" Trial: A Trial Designed to Prospectively Validate Predictive Models of Response to High Dose IL-2 Treatment in Patients With Metastatic Renal Cell Carcinoma |
- To determine, in a prospective fashion, if the response rate to high-dose IL-2 for patients with metastatic renal cell carcinoma and "good" pathologic predictive features is significantly higher than a historical, unselected patient population [ Time Frame: months ] [ Designated as safety issue: No ]
- To determine the response rate to high-dose IL-2 for patients with metastatic renal cell carcinoma and "poor" pathologic predictive features and to compare this response rate to the response rate of patients with "good" pathologic predictive features [ Time Frame: months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 110 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | November 2009 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
High-dose IL-2
|
Drug: aldesleukin (Proleukin)
Eligible patients will receive treatment with IL-2 alone following the FDA approved schedule. A treatment course consists of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 8-12 weeks of rest. A cycle is defined as 5 days of treatment. Patients will receive IL-2, 600,000 International Units/kg/dose (Chiron) intravenously (IV) every 8 (q8) hours for five days (maximum of 14 doses), beginning on day 1 and again on day 15. |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must have histologically confirmed renal cell carcinoma that is metastatic or unresectable.
- If patients have measurable disease restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology.
- Patients must provide access to tissue blocks containing adequate tumor for interpretation and analysis.
- Patients must have measurable disease.
- Patients must have good performance status (ECOG 0 or 1; Karnofsky PS 100-80%).
- Patients must have adequate organ function.
- Patients must have no contraindication of vasopressor agents.
- Patients must be ≥ 18 years of age.
Exclusion Criteria:
- Patients who have received systemic therapy for metastatic disease.
- Patients with organ allografts.
- Patients who require or are likely to require systemic corticosteroid therapy for intercurrent illness.
- Patients with any significant medical disease other than the malignancy (e.g. COPD, patients with ascites or pleural effusions), which in the opinion of the investigator would significantly increase the risk of immunotherapy.
- Patients with a history of another malignancy within the past 5 years other than surgically cured non-melanoma skin cancer, carcinoma-in-situ or Stage I carcinoma of the cervix.
Contacts and Locations| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Study Chair: | David F McDermott, MD | Beth Israel Deaconess Medical Center |
| Principal Investigator: | Kim Margolin, MD | City of Hope National Medical Center |
| Principal Investigator: | Walter Urba, MD | Chiles Cancer Center |
| Principal Investigator: | Marc Ernstoff, MD | Dartmouth-Hitchcock Medical Center |
| Principal Investigator: | Theodore Logan, MD | Indiana University |
| Principal Investigator: | Joseph Clark, MD | Loyola University |
| Principal Investigator: | Janice Dutcher, MD | Our Lady of Mercy Cancer Center |
| Principal Investigator: | Michael Wong, MD | Roswell Park Cancer Institute |
| Principal Investigator: | Allen Pantuck, MD | University of California, Los Angeles |
| Principal Investigator: | Leslie Oleksowicz, MD | University of Cincinnati |
| Principal Investigator: | Leonard Appleman, MD | University of Pittsburgh |
| Principal Investigator: | Geoffrey Weiss, MD | University of Virginia |
| Principal Investigator: | Jeffrey Sosman, MD | Vanderbilt University |
| Principal Investigator: | Ulka Vaishampayan, MD | Wayne State University |
More Information
Publications:
| Responsible Party: | David McDermott, MD, Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT00554515 History of Changes |
| Obsolete Identifiers: | NCT00536757 |
| Other Study ID Numbers: | DFHCC 06-149 |
| Study First Received: | November 6, 2007 |
| Last Updated: | October 5, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dana-Farber Cancer Institute:
|
Kidney Renal Cell Metastatic interleukin-2 select |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Aldesleukin Interleukin-2 |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 22, 2013