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

Metastatic Melanoma Clinical Trial

Official title:

Phase 2 Trial of T-cell Based Low-dose Cyclophosphamide and Outpatient Intravenous Interleukin-2 in Metastatic Melanoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01833767
• Other study ID #: 12-12
• Status: Withdrawn
• Phase: Phase 2
• First received: April 14, 2013
• Last updated: August 22, 2017
• Start date: October 2012
• Est. completion date: December 2015

Study information

• Verified date: August 2017
• Source: Western Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Intervention

Drug:
• Cyclophosphamide and Interleukin 2
Cytoxan IV day 1, IL2 IV days 1-5

Locations

Country	Name	City	State
United States	Western Regional Medical Center Inc	Goodyear	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Western Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate		One year
Secondary	Median Survival		One year