Trial of Outpatient Intravenous Interleukin-2 in Malignant Melanoma and Metastatic Kidney Cancer
This study has been withdrawn prior to enrollment.
(Primary Investigator is no longer employed at LLU as of 02/29/12.)
Sponsor:
Loma Linda University
Information provided by (Responsible Party):
Chien-Shing Chen, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01355562
First received: April 28, 2011
Last updated: October 3, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The current study will test single agent IL-2 in stage IV melanoma and kidney cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma Metastatic Kidney Cancer |
Drug: Interleukin-2 (IL-2) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Outpatient Intravenous Interleukin-2 in Malignant Melanoma and Metastatic Kidney Cancer |
Resource links provided by NLM:
Further study details as provided by Loma Linda University:
Primary Outcome Measures:
- Response rate [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- how long the tumor shrinkage lasts [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | March 2011 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Interleukin-2 (IL-2)
Daily for 4 doses every 3 weeks for a total of 12 doses in an outpatient setting
The current study will test single agent IL-2 given daily for 4 doses every 3 weeks for a total of 12 doses in an outpatient setting in stage IV melanoma and kidney cancer to attempt to determine the response rate, how long the responses last, and median survival of this regimen in these two diseases. Responding patients and those with absence of disease progression may receive additional cycles of therapy every 3 weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must have a histologic diagnosis of metastatic kidney cancer or malignant melanoma Patients may be either newly diagnosed with metastatic disease or may have received prior treatment for metastatic kidney cancer.
- Patients must have measurable disease on physical exam or radiologic studies.
- ECOG performance status of 0 or 1 and estimated survival of at least 3 months.
- White blood count of > 3500/mm3, platelet count > 100,000/mm3, hemoglobin > 9.0 gm/dl; bilirubin, ALT, AST < 2 x upper limit of normal; serum creatinine < 2.0 mg/dl.
- Patients must undergo a low-level cardiac stress test (or similar cardiac evaluation such as dobutamine stress echocardiogram or radionuclide-based stress test) for possible atherosclerotic heart disease. Patients with a positive stress test would be excluded from this trial.
- Patients with elevated temperatures > 100.5 F must have sources of occult infection excluded.
- Patients must be felt to have recovered from effects of prior therapy, such as > 2 weeks after prior chemotherapy.
Exclusion Criteria:
- Medical illness requiring corticosteroids or other immunosuppressive agents (such as cyclosporin or methotrexate).
- Autoimmune disease such as inflammatory arthritis, which could be exacerbated by immune-based therapy.
- Prior history of psychiatric disorder, which could be exacerbated by interleukin-2.
- Lactation or pregnancy.
- Evidence of significant cardiovascular disease including history of recent (< 6 months prior) myocardial infarction, congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional PVC's, angina, positive low-level stress test, or cerebrovascular accident.
- Current brain metastasis.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01355562
Locations
| United States, California | |
| Highland Springs Medical Plaza | |
| Beaumont, California, United States, 92223 | |
| Loma Linda University Cancer Center | |
| Loma Linda, California, United States, 92354 | |
Sponsors and Collaborators
Loma Linda University
Investigators
| Principal Investigator: | Walter Quan, Jr., M.D. | Loma Linda University Cancer Center |
More Information
Additional Information:
Related Info 
No publications provided
| Responsible Party: | Chien-Shing Chen, M.D., Ph.D., Loma Linda University |
| ClinicalTrials.gov Identifier: | NCT01355562 History of Changes |
| Other Study ID Numbers: | LLU1101 |
| Study First Received: | April 28, 2011 |
| Last Updated: | October 3, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
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 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 |
ClinicalTrials.gov processed this record on May 19, 2013