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This study has been withdrawn prior to enrollment.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.)
Information provided by (Responsible Party):
Chien-Shing Chen, Loma Linda University
First received: April 28, 2011
Last updated: October 3, 2012
Last verified: October 2012
The current study will test single agent IL-2 in stage IV melanoma and kidney cancer.
Metastatic Kidney Cancer
Drug: Interleukin-2 (IL-2)
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Trial of Outpatient Intravenous Interleukin-2 in Malignant Melanoma and Metastatic Kidney Cancer
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2012 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01355562
|Highland Springs Medical Plaza
|Beaumont, California, United States, 92223 |
|Loma Linda University Cancer Center
|Loma Linda, California, United States, 92354 |
Loma Linda University
||Walter Quan, Jr., M.D.
||Loma Linda University Cancer Center
No publications provided
||Chien-Shing Chen, M.D., Ph.D., Loma Linda University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 28, 2011
||October 3, 2012
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 19, 2013
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents