Phase 1/2 study of recombinant vaccinia-NY-ESO-1 (rV-NY-ESO-1) and recombinant fowlpox-NY-ESO-1 (rF-NY-ESO-1) in patients with NY-ESO-1 or LAGE positive cancers
- Conditions
- C80Malignant neoplasm, without specification of site
- Registration Number
- DRKS00000194
- Lead Sponsor
- Krankenhaus Nordwest 2. Medizinische Klinik
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Patients will be eligible for enrollment if they fulfill the following criteria:
1.Histologically confirmed metastatic, measurable cancer or resected high risk Stage 3 or 4 with no evidence of disease with failure or refusal of standard chemotherapy or other proven treatment.
2.Histologically confirmed malignant melanoma, AJCC stage III (unresectable) or IV (Applicable for cohort 6 only).
3.Measurable disease using RECIST criteria (Appendix 4) (Applicable for cohort 6 only).
4.Tumor expression of NY-ESO-1 determined by RT-PCR analysis (see Appendix 1), preferably, or by immunohistochemistry (see Appendix 2) or LAGE by RT-PCR or serum antibody against NY-ESO-1 measured by Western Blot or ELISA (see section 7.2.1 and reference17)
5.HLA-A2 positive (applies only for entry to Cohorts 1, 2, 3, and 4).
6.Expected survival of at least five months.
7.Full recovery from surgery.
8.Karnofsky scale performance status of 70% or more.
9.The following laboratory results:
Neutrophil countgreater or equal 2.0 x 109/L
Lymphocyte countgreater or equal 0.5 x 109/L
Platelet countgreater or equal 100 x 109/L
Serum creatinineless or equal 2 mg/dL
Serum bilirubinless or equal 2 mg/dL
10.Ability to avoid close contact with children < 3 years of age; pregnant or breast feeding women; individuals with active, or a history of, eczema or other skin disorders; and immunocompromised individuals.
11.Have been informed of other treatment options.
12.Age: 18 years or older and able to give written informed consent (see Section 12.2).
Patients will be excluded from the study if they fulfill any of the following criteria:
1.Clinically significant heart disease (NYHA Class III or IV).
2.Other serious illnesses (eg, serious infections requiring antibiotics, bleeding disorders).
3.History of immunodeficiency disease or autoimmune disease.
4.Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available.
5.Known HIV positivity.
6.Chemotherapy, radiation therapy, or immunotherapy within 4 weeks before study entry (6 weeks for nitrosoureas).
7.Known allergy to eggs, determined by history.
8.Concomitant treatment with steroids, antihistaminic drugs, or nonsteroidal anti-inflammatory drugs (unless used as in low doses for prevention of an acute cardiovascular event or for pain control). Topical or inhalational steroids are permitted.
9.Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
10.Pregnancy or lactation.
11.Women of childbearing potential who are not using a medically acceptable means of contraception.
12.Eczema or a history of eczema; other acute, chronic or exfoliative skin disorders (eg, atoptic dermatitis, burns, impetigo, or varicella zoster).
13.Psychiatric or addictive disorders that may compromise the ability to give informed consent.
14.Lack of availability of a patient for immunological and clinical follow-up assessment.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Toxicity as defined by NCI Common Toxicity Criteria, Tumor response by RECIST criteria, NY-ESO-1 specific cellular and humoral immunity
- Secondary Outcome Measures
Name Time Method