search
Back to results

Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma

Primary Purpose

Recurrent Melanoma, Stage IV Melanoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
gp100:209-217(210M) peptide vaccine
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically or cytologically confirmed cutaneous melanoma with clinical evidence of distant, metastatic, unresectable regional lymphatic, or extensive in-transit recurrent disease HLA-A2*0201 positive by genotyping Measurable disease as defined by the following: At least 1 lesion accurately measured in at least 1 dimension At least 20 mm by conventional techniques At least 10 mm by spiral CT scan Lesions considered intrinsically nonmeasurable include: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Inflammatory breast disease Lymphangitis cutis/pulmonis Abdominal masses not confirmed and followed by imaging techniques Cystic lesions Lesions situated in a previously irradiated area No ocular or mucosal melanoma No prior or concurrent liver or brain metastases Performance status - ECOG 0-1 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL LDH normal Bilirubin normal AST no greater than 2.5 times upper limit of normal Creatinine normal No congestive heart failure, angina, or symptomatic cardiac arrhythmia No myocardial infarction within the past 6 months No severe chronic pulmonary disease Not pregnant or nursing Fertile patients must use effective contraception No primary or secondary immunodeficiency or autoimmune disease No currently active second malignancy (e.g., patient has completed therapy and is considered unlikely to have recurrence within 1 year) other than nonmelanoma skin cancer At least 4 weeks since prior immunotherapy No prior interleukin-2 No prior whole cell or gp100:209-217(210M)-targeted melanoma vaccine No other concurrent cytokines or growth factors At least 4 weeks since prior chemotherapy At least 1 month since prior systemic corticosteroids No concurrent systemic, inhaled, or topical corticosteroids At least 1 month since other prior immunosuppressive medication No antihypertensive medications from 1 day prior until 2 days after first course

Sites / Locations

  • Cancer and Leukemia Group B

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (gp100:209-217, aldesleukin )

Arm Description

Patients receive gp100:209-217(210M) emulsified in Montanide ISA-51 SC on day 1 and interleukin-2 SC on days 1-5 and 8-13. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. Patients with a CR receive 3 additional courses after achieving CR.

Outcomes

Primary Outcome Measures

Clinical response rate (CR or PR)

Secondary Outcome Measures

Response duration
The Kaplan-Meier method will be used to estimate duration of response.
Progression-free intervals
The Kaplan-Meier method will be used to estimate time to progression.
Immunologic response rate using ELISPOT assay
Described in terms of frequency and kinetics. Agreement between clinical and immunological response will be measured using the kappa coefficient.

Full Information

First Posted
July 5, 2000
Last Updated
January 15, 2013
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00005949
Brief Title
Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma
Official Title
Phase II Study of Melanoma Vaccine (NSC #683472/675756, IND #6123) and Low-Dose, Subcutaneous Interleukin-2 in Advanced Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
Phase II trial to study the effectiveness of vaccine therapy plus interleukin-2 in treating patients who have advanced melanoma. Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Melanoma vaccine plus interleukin-2 may kill more cancer cells
Detailed Description
PRIMARY OBJECTIVES: I. Determine clinical response rates in patients with advanced melanoma treated with gp100:209-217(210M) melanoma vaccine and low-dose interleukin-2. II. Assess response duration and progression-free intervals in these patients receiving this treatment. OUTLINE: Patients receive gp100:209-217(210M) emulsified in Montanide ISA-51 subcutaneously (SC) on day 1 and interleukin-2 SC on days 1-5 and 8-13. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. Patients with a complete response (CR) receive 3 additional courses after achieving CR. Patients are followed every 9 weeks for 3 years or until disease recurrence. PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 3.5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Melanoma, Stage IV Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (gp100:209-217, aldesleukin )
Arm Type
Experimental
Arm Description
Patients receive gp100:209-217(210M) emulsified in Montanide ISA-51 SC on day 1 and interleukin-2 SC on days 1-5 and 8-13. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. Patients with a CR receive 3 additional courses after achieving CR.
Intervention Type
Biological
Intervention Name(s)
aldesleukin
Other Intervention Name(s)
IL-2, Proleukin, recombinant human interleukin-2, recombinant interleukin-2
Intervention Description
Given SC
Intervention Type
Biological
Intervention Name(s)
gp100:209-217(210M) peptide vaccine
Other Intervention Name(s)
G9 209-2M, gp100:209-217(210M)
Intervention Description
Given SC
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Clinical response rate (CR or PR)
Time Frame
From the start of treatment until disease progression/recurrence, assessed up to 3 years
Secondary Outcome Measure Information:
Title
Response duration
Description
The Kaplan-Meier method will be used to estimate duration of response.
Time Frame
Up to 3 years
Title
Progression-free intervals
Description
The Kaplan-Meier method will be used to estimate time to progression.
Time Frame
Up to 3 years
Title
Immunologic response rate using ELISPOT assay
Description
Described in terms of frequency and kinetics. Agreement between clinical and immunological response will be measured using the kappa coefficient.
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed cutaneous melanoma with clinical evidence of distant, metastatic, unresectable regional lymphatic, or extensive in-transit recurrent disease HLA-A2*0201 positive by genotyping Measurable disease as defined by the following: At least 1 lesion accurately measured in at least 1 dimension At least 20 mm by conventional techniques At least 10 mm by spiral CT scan Lesions considered intrinsically nonmeasurable include: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Inflammatory breast disease Lymphangitis cutis/pulmonis Abdominal masses not confirmed and followed by imaging techniques Cystic lesions Lesions situated in a previously irradiated area No ocular or mucosal melanoma No prior or concurrent liver or brain metastases Performance status - ECOG 0-1 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL LDH normal Bilirubin normal AST no greater than 2.5 times upper limit of normal Creatinine normal No congestive heart failure, angina, or symptomatic cardiac arrhythmia No myocardial infarction within the past 6 months No severe chronic pulmonary disease Not pregnant or nursing Fertile patients must use effective contraception No primary or secondary immunodeficiency or autoimmune disease No currently active second malignancy (e.g., patient has completed therapy and is considered unlikely to have recurrence within 1 year) other than nonmelanoma skin cancer At least 4 weeks since prior immunotherapy No prior interleukin-2 No prior whole cell or gp100:209-217(210M)-targeted melanoma vaccine No other concurrent cytokines or growth factors At least 4 weeks since prior chemotherapy At least 1 month since prior systemic corticosteroids No concurrent systemic, inhaled, or topical corticosteroids At least 1 month since other prior immunosuppressive medication No antihypertensive medications from 1 day prior until 2 days after first course
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Roberts
Organizational Affiliation
Cancer and Leukemia Group B
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer and Leukemia Group B
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60606
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma

We'll reach out to this number within 24 hrs