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
  Purpose

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.


Condition Intervention Phase
Metastatic Melanoma
Drug: Cyclophosphamide and Interleukin 2
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Trial of T-cell Based Low-dose Cyclophosphamide and Outpatient Intravenous Interleukin-2 in Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by Western Regional Medical Center:

Primary Outcome Measures:
  • Response Rate [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median Survival [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cyclophosphamide and Interleukin-2
Cytoxan IV on day 1, IL2 IV on days 1-5
Drug: Cyclophosphamide and Interleukin 2
Cytoxan IV day 1, IL2 IV days 1-5
Other Names:
  • Cytoxan
  • IL2

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01833767

Contacts
Contact: Marci Pierog, RN 623 207-3000 marci.pierog@ctca-hope.com
Contact: India Hill, CCRP 623 207-3000 india.hill@ctca-hope.com

Locations
United States, Arizona
Western Regional Medical Center Inc Recruiting
Goodyear, Arizona, United States, 85338
Principal Investigator: Walter Quan, MD         
Sponsors and Collaborators
Western Regional Medical Center
Investigators
Principal Investigator: Walter Quan, MD Western Regional Medical Center
  More Information

No publications provided

Responsible Party: Walter Quan Jr., MD, Cheif of Medical Oncology, Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT01833767     History of Changes
Other Study ID Numbers: 12-12
Study First Received: April 14, 2013
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Nevi and Melanomas
Interleukin-2
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 23, 2014