Clinical trial NCT00005949: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Melanoma
Stage IV Melanoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical response rate (CR or PR)
timeFrame: From the start of treatment until disease progression/recurrence, assessed up to 3 years
Secondary outcomes:
measure: Response duration
timeFrame: Up to 3 years
measure: Progression-free intervals
timeFrame: Up to 3 years
measure: Immunologic response rate using ELISPOT assay
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Cancer and Leukemia Group B
state: Illinois
Study officials:
affiliation: Cancer and Leukemia Group B
name: John Roberts
role: PRINCIPAL_INVESTIGATOR
References: