NCT00086866UnknownPhase 2
Randomized, Open Phase II Study of Immunization With the Recombinant MAGE-3 Protein Combined With Adjuvant AS02B or AS15 in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma
European Organisation for Research and Treatment of Cancer - EORTC21 sites in 7 countries165 target enrollmentStarted: May 1, 2004Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 165
- Locations
- 21
- Primary Endpoint
- Vaccine-related toxicity as assessed by CTCAE v3
Study Overview
Brief Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: This randomized phase II trial is studying two different regimens of vaccine therapy and comparing them to see how well they work in treating patients with stage III or stage IV melanoma that cannot be removed with surgery.
Detailed Description
OBJECTIVES:
Primary
- Compare the objective response rate (complete and partial response) in patients with unresectable stage III or stage IV M1a cutaneous melanoma immunized with vaccine comprising D1/3-MAGE-3-His fusion protein and SB-AS02B adjuvant vs SB-AS15 adjuvant.
- Compare the activity of SB-AS02B adjuvant vs SB-AS15 adjuvant, in terms of maximizing the antigenicity of MAGE-3, in patients treated with these regimens.
- Compare the rate of grade 3/4 vaccine-related toxicity in patients treated with these regimens.
Secondary
- Compare progression-free survival in patients treated with these regimens.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed cutaneous melanoma
- •Unresectable stage III OR stage IV M1a disease
- •Documented progressive disease within the past 12 weeks
- •Measurable disease
- •Skin, soft tissue, or lymph node metastasis allowed provided the disease is not amenable to curative treatment with surgery
- •Tumor must express the MAGE-3 gene by reverse transcription polymerase chain reaction analysis (more than 1% of the positive MAGE-3 control included in the assay)
- •No visceral metastases within the past 56 days by imaging
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Hemoglobin ≥ lower limit of normal (LLN)
- •WBC ≥ LLN
- •Lymphocyte count ≥ LLN
- •Platelet count ≥ LLN
- •No bleeding disorders
- •Bilirubin ≤ upper limit of normal (ULN)
- •Lactic dehydrogenase ≤ ULN
- •AST and ALT ≤ 2 times ULN
- •PT and aPTT normal
- •Hepatitis B surface antigen negative (antibody test may be positive)
- •Hepatitis C antibody negative
- •Creatinine ≤ ULN
- •Cardiovascular
- •No clinically significant heart disease (CTC grade III or IV)
- •Immunologic
- •No autoimmune disease (vitiligo allowed)
- •No anti-nuclear antibody titer ≥ 1/320 OR equal to 1/160 AND auto-antibodies directed against specific auto-antigens
- •No immunodeficiency
- •No active infection requiring antibiotic therapy
- •HIV negative
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study participation
- •No other malignancy within the past 5 years except surgically cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •No other serious acute or chronic illness requiring concurrent medications
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 8 weeks since prior adjuvant vaccine therapy
- •No prior vaccine therapy containing a MAGE-3 antigen
- •No prior vaccine therapy for metastatic melanoma
- •No concurrent immunomodulating agents (e.g., BCG)
- •Chemotherapy
- •No prior systemic chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy
- +15 more not shown
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Vaccine-related toxicity as assessed by CTCAE v3
Response rate (complete response and partial response) as assessed by RECIST criteria
Secondary Outcomes
- Rate of stabilization as assessed by RECIST criteria
- Rate of immune response
- Rate of mixed response as assessed by RECIST criteria
- Progression-free survival
Investigators
Study Sites (21)
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