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Trial record 34 of 2177 for:    Melanoma

Interleukin-2 in Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT01702896
Recruitment Status : Terminated (PI Decision)
First Posted : October 10, 2012
Results First Posted : February 7, 2018
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Western Regional Medical Center

Brief Summary:
To determine whether Interleukin-2 at the dose and schedule will help to increase tumor shrinkage

Condition or disease Intervention/treatment Phase
Melanoma Metastatic Drug: Interleukin-2 Phase 2

Detailed Description:
In this phase II trial, the previously described IL-2 schedule (daily IL-2 for 5 days (per week) every 3 weeks) will be tested in a larger cohort of patients with melanoma to attempt to determine the response rate, median duration of response, and median survival. The dose intensity of this schedule would allow a patient treated on this regimen to achieve the target threshold (> 1440 million IU/m2/year).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Moderate Dose Bolus Interleukin-2 in Metastatic Melanoma
Actual Study Start Date : September 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Interleukin-2
Interleukin-2 will be used in this group
Drug: Interleukin-2
Interleukin-2
Other Name: IL2




Primary Outcome Measures :
  1. Response Rate [ Time Frame: Measured until Disease Progression or death from any cause up to 2 years ]
    Radiographic studies to evaluate for response were done after every 2 cycles (6 weeks) until disease progression or death from any cause up to 2 years. Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = 100%(CR + PR/total number of patients receiving Interleukin-2).


Secondary Outcome Measures :
  1. Median Duration of Response [ Time Frame: Measured until Disease Progression or death from any cause up to 2 years ]
    Duration of response is calculated as the time (months) from the date at which response is first observed (per standard Response Evaluation Criteria In Solid Tumors [RECIST] to the date of first observed disease progression or date of death from any cause, whichever came first, assessed up to 2 years. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.

  2. Median Survival [ Time Frame: From time of study entry until death, up to 10 years ]
    Measured from date of entry on study until date of death



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 bi-dimensional 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. Patient consent must be obtained prior to entrance onto study.
  9. Women of childbearing potential must have a negative pregnancy test and must take adequate precautions to prevent pregnancy during treatment

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.

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): NCT01702896


Locations
United States, Arizona
Western Regional Medical Center, Inc.
Goodyear, Arizona, United States, 85338
Sponsors and Collaborators
Western Regional Medical Center
Investigators
Study Director: Jordan Waypa, FNP Research Director

Responsible Party: Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT01702896     History of Changes
Other Study ID Numbers: 12-07
First Posted: October 10, 2012    Key Record Dates
Results First Posted: February 7, 2018
Last Update Posted: April 5, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Western Regional Medical Center:
Metastatic Melanoma

Additional relevant MeSH terms:
Melanoma
Nevi and Melanomas
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Interleukin-2
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs