Clinical trial · Interventional
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
NCT00005949CI-TRIAL-00008954completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| gp100:209-217(210M) peptide vaccine | Biological | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (gp100:209-217, aldesleukin )
- 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.
- interventionNames
- Biological: aldesleukin
- Biological: gp100:209-217(210M) peptide vaccine
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Clinical response rate (CR or PR)
- timeFrame
- From the start of treatment until disease progression/recurrence, assessed up to 3 years
Secondary outcomes (3)
- measure
- Response duration
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 courseReferences
Publications (0)
Data not yet available
No reference posted for this study.