We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
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This study has been withdrawn prior to enrollment.
(No participants enrolled)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01833767
First Posted: April 17, 2013
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jordan Waypa, Western Regional Medical Center
  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: None (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 Jordan Waypa, Western Regional Medical Center:

Primary Outcome Measures:
  • Response Rate [ Time Frame: One year ]

Secondary Outcome Measures:
  • Median Survival [ Time Frame: One year ]

Enrollment: 0
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833767


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

Responsible Party: Jordan Waypa, Research Director, Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT01833767     History of Changes
Other Study ID Numbers: 12-12
First Submitted: April 14, 2013
First Posted: April 17, 2013
Last Update Posted: August 24, 2017
Last Verified: August 2017

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
Antirheumatic Agents
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