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This study has been withdrawn prior to enrollment.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:
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

April 28, 2011
October 3, 2012
March 2011
February 2012   (final data collection date for primary outcome measure)
Response rate [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01355562 on ClinicalTrials.gov Archive Site
how long the tumor shrinkage lasts [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Trial of Outpatient Intravenous Interleukin-2 in Malignant Melanoma and Metastatic Kidney Cancer
Phase II Trial of Outpatient Intravenous Interleukin-2 in Malignant Melanoma and Metastatic Kidney Cancer

The current study will test single agent IL-2 in stage IV melanoma and kidney cancer.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Melanoma
  • Metastatic Kidney Cancer
Drug: Interleukin-2 (IL-2)
Daily for 4 doses every 3 weeks for a total of 12 doses in an outpatient setting
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
February 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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.
  2. Patients must have measurable disease on physical exam or radiologic studies.
  3. ECOG performance status of 0 or 1 and estimated survival of at least 3 months.
  4. 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.
  5. 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.
  6. Patients with elevated temperatures > 100.5 F must have sources of occult infection excluded.
  7. Patients must be felt to have recovered from effects of prior therapy, such as > 2 weeks after prior chemotherapy.

Exclusion Criteria:

  1. Medical illness requiring corticosteroids or other immunosuppressive agents (such as cyclosporin or methotrexate).
  2. Autoimmune disease such as inflammatory arthritis, which could be exacerbated by immune-based therapy.
  3. Prior history of psychiatric disorder, which could be exacerbated by interleukin-2.
  4. Lactation or pregnancy.
  5. 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.
  6. Current brain metastasis.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01355562
LLU1101
No
Chien-Shing Chen, Loma Linda University
Loma Linda University
Not Provided
Principal Investigator: Walter Quan, Jr., M.D. Loma Linda University Cancer Center
Loma Linda University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP