Interleukin-2 in Metastatic Melanoma

NCT01702896 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 12-07
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Melanoma Metastatic

Keywords

Metastatic Melanoma

Outcome Measures

Primary Outcomes (1)

• Response Rate

  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).

  Measured until Disease Progression or death from any cause up to 2 years

Secondary Outcomes (2)

• Median Duration of Response

  Measured until Disease Progression or death from any cause up to 2 years

• Median Survival

  From time of study entry until death, up to 10 years

Study Arms (1)

Interleukin-2

EXPERIMENTAL

Interleukin-2 will be used in this group

Drug: Interleukin-2

Interventions

Interleukin-2 DRUG

Interleukin-2

Also known as: IL2

Interleukin-2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a histologic diagnosis of metastatic melanoma. Patients may have received prior systemic therapy or may be previously untreated.
• Patients must have bi-dimensional measurable disease on physical exam or radiologic studies.
• ECOG performance status of 0 or 1 and estimated survival of at least 3 months.
• 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.
• 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.
• Patients with elevated temperatures \> 100.5 F must have sources of occult infection excluded.
• Patients must be felt to have recovered from effects of prior therapy, such as \> 2 weeks after prior chemotherapy.
• Patient consent must be obtained prior to entrance onto study.
• Women of childbearing potential must have a negative pregnancy test and must take adequate precautions to prevent pregnancy during treatment

You may not qualify if:

• Medical illness requiring corticosteroids or other immunosuppressive agents (such as cyclosporin or methotrexate.
• Autoimmune disease such as inflammatory arthritis which could be exacerbated by immune-based therapy.
• Prior history of psychiatric disorder which could be exacerbated by interleukin-2.
• Lactation or pregnancy.
• 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.
• Current brain metastasis.

Sponsors & Collaborators

• Western Regional Medical Center: lead

Study Sites (1)

Western Regional Medical Center, Inc.

Goodyear, Arizona, 85338, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Results Point of Contact

• Title: Jessica L. Coats
• Organization: Western Regional Medical Center

jessica.coats@ctca-hope.com

623-207-3899

Study Officials

• Jordan Waypa, FNP

  Research Director

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2012
• First Posted: October 10, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 5, 2018
• Results First Posted: February 7, 2018

Record last verified: 2018-04

Locations

US (1)