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Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00005949
Enrollment
50
Registered
2003-01-27
Start date
2001-03-31
Completion date
Unknown
Last updated
2013-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Melanoma, Stage IV Melanoma

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.

Interventions

BIOLOGICALaldesleukin

Given SC

OTHERlaboratory biomarker analysis

Correlative studies

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Clinical response rate (CR or PR)From the start of treatment until disease progression/recurrence, assessed up to 3 years

Secondary

MeasureTime frameDescription
Response durationUp to 3 yearsThe Kaplan-Meier method will be used to estimate duration of response.
Progression-free intervalsUp to 3 yearsThe Kaplan-Meier method will be used to estimate time to progression.
Immunologic response rate using ELISPOT assayUp to 3 yearsDescribed in terms of frequency and kinetics. Agreement between clinical and immunological response will be measured using the kappa coefficient.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026