Trial record 2 of 3 for:    Interleukin-2 in Metastatic Melanoma quan

Low-dose Cyclophosphamide and Outpatient IV Interleukin-2 in Metastatic Melanoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Western Regional Medical Center
Sponsor:
Information provided by (Responsible Party):
Walter Quan Jr., MD, Western Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01833767
First received: April 14, 2013
Last updated: January 9, 2014
Last verified: January 2014

April 14, 2013
January 9, 2014
October 2012
December 2015   (final data collection date for primary outcome measure)
Response Rate [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01833767 on ClinicalTrials.gov Archive Site
Median Survival [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Low-dose Cyclophosphamide and Outpatient IV Interleukin-2 in Metastatic Melanoma
Phase 2 Trial of T-cell Based Low-dose Cyclophosphamide and Outpatient Intravenous Interleukin-2 in Metastatic Melanoma

The purpose of this study is to determine response rates by administering low dose cyclophosphamide on day 1, followed by 5 days of outpatient IL2.

To determine the response rate, median duration of response and median survival of patients treated with this low-dose cyclophosphamide + moderate dose bolus Interleukin-2 schedule.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Melanoma
Drug: Cyclophosphamide and Interleukin 2
Cytoxan IV day 1, IL2 IV days 1-5
Other Names:
  • Cytoxan
  • IL2
Experimental: Cyclophosphamide and Interleukin-2
Cytoxan IV on day 1, IL2 IV on days 1-5
Intervention: Drug: Cyclophosphamide and Interleukin 2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
35
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients must have a histologic diagnosis of metastatic melanoma. Patients may have received prior systemic therapy or may be previously untreated.
  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 < 3 x upper limit of normal; serum creatinine < 2.0 mg/dl.
  5. Patients must undergo a low-level cardiac stress test as a screen 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.
  8. Women of childbearing potential must have a negative pregnancy test and adequate precautions to prevent pregnancy during treatment must be taken.
  9. Patient consent must be obtained prior to entrance onto study.

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 untreated brain metastasis.

Both
18 Years and older
No
Contact: Marci Pierog, RN 623 207-3000 marci.pierog@ctca-hope.com
Contact: India Hill, CCRP 623 207-3000 india.hill@ctca-hope.com
United States
 
NCT01833767
12-12
No
Walter Quan Jr., MD, Western Regional Medical Center
Western Regional Medical Center
Not Provided
Principal Investigator: Walter Quan, MD Western Regional Medical Center
Western Regional Medical Center
January 2014

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