Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma

Stage IV Melanoma Clinical Trial

Official title:

Phase II Study of Melanoma Vaccine (NSC #683472/675756, IND #6123) and Low-Dose, Subcutaneous Interleukin-2 in Advanced Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005949
• Other study ID #: NCI-2012-02337
• Secondary ID: CLB-509901U10CA0
• Status: Completed
• Phase: Phase 2
• First received: July 5, 2000
• Last updated: January 15, 2013
• Start date: March 2001

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Recurrent Melanoma
• Stage IV Melanoma

Intervention

Biological:
• aldesleukin
Given SC
• gp100:209-217(210M) peptide vaccine
Given SC

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Cancer and Leukemia Group B	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response rate (CR or PR)		From the start of treatment until disease progression/recurrence, assessed up to 3 years	No
Secondary	Response duration	The Kaplan-Meier method will be used to estimate duration of response.	Up to 3 years	No
Secondary	Progression-free intervals	The Kaplan-Meier method will be used to estimate time to progression.	Up to 3 years	No
Secondary	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.	Up to 3 years	No