Status:
TERMINATED
Suicide Plus Immune Gene Therapy for Advanced Melanoma
Lead Sponsor:
Hospital Italiano de Buenos Aires
Collaborating Sponsors:
Instituto de Oncología Ángel H. Roffo
National Agency for Scientific and Technological Promotion, Argentina
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Safety evaluation of combined immunogene therapy in patients with advanced melanoma.
Detailed Description
This phase I clinical protocol is proposed to evaluate the safety of combined immunotherapy genetics in humans. This treatment combines the high local cytotoxicity of the suicide gene system (HSV thy...
Eligibility Criteria
Inclusion
- Patients with histologically and / or cytologically confirmed melanoma.
- Patients progressed or are intolerant to conventional systemic treatments.
- Patients that are not candidates for surgery under oncologic criteria (complete resection).
- Performance status (ECOG) 0 or 1.
- Patients with life expectancy greater than 6 months.
- Patients with at least one accessible target lesion for gene inoculation (superficial localizations of the primary tumor, satelitosis, subcutaneous or accessible lymph node metastasis).
- Patients with measurable disease (according to RECIST 1.1 criteria, irrespective of the target lesion chosen for suicide gene inoculation)
- Patients with signed informed consent.
Exclusion
- Patients with uncontrolled cardiovascular disease
- Patients with uncontrolled respiratory disease.
- Patients with uncontrolled immune disease.
- Patients with glucocorticoids or immunosuppressive drugs or agents with immunomodulatory activity (except non-steroidal anti-inflammatory agents) up to 2 weeks before treatment.
- Patients performing other experimental therapies.
- Patients who are pregnant or breastfeeding.
- Patients undergoing concurrent chemotherapy or radiation therapy.
- Uncontrolled diabetes.
- Patients with active diagnosis of other malignant neoplasms.
- HIV-positive patients.
- Uncontrolled thyroid abnormality.
- Patients with significant medical morbidity.
- Patients with a history of allergic reactions to chemicals or similar to those used in this study.
- Metastasis in the central nervous system.
- Laboratory eligibility criteria excluded:
- Hemoglobin: \<8 g / dL, leukocytes: \<3,000 / mm3, platelets: \<100,000 / mm3, neutrophils: \<1000 / mm3, hematocrit: \<25%. bilirubin\> 2.0 mg / dL, GOT or GPT: 2.5 times\> than normal upper institutional limit (ULN), alkaline phosphatase: 2 times\> ULN, creatinine\> 2.0 mg / dL, creatinine clearence : \<60 ml / min / 1.73 m2.
Key Trial Info
Start Date :
February 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2020
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03338777
Start Date
February 20 2020
End Date
February 20 2020
Last Update
February 25 2020
Active Locations (1)
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1
Hospital Italiano
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina