Status:
TERMINATED
Phase II FANG™ in Advanced Melanoma
Lead Sponsor:
Gradalis, Inc.
Conditions:
Advanced Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Preliminary studies with a variety of vaccines suggest target accessibility (potential immunogenicity) in a variety of solid tumors to immune directed approaches. In an effort to overcome limitations ...
Eligibility Criteria
Inclusion
- Histologically confirmed Stages IIIc and IV melanoma.
- Has been informed of all alternative ≥ second-line therapies that are the current standard of care. If no conventional frontline therapy indicated or acceptable by patient, patient may participate after review by sponsor.
- Clinically (medically) indicated procedure (i.e. biopsy of lesions of recurrent disease, palliative management via resection, thoracentesis, etc.) to collect viable tumor in sufficient quantity ("golf ball size" estimated weight \~ 30 grams, pleural and/or ascites fluid estimated volume ≥ 500mL) for vaccine processing.
- Recovered to ≤ Grade 1 (excluding alopecia) from all clinically relevant toxicities related to prior therapies.
- Patients will be allowed to participate following single prior CNS treatment with stereotactic radiotherapy whole brain irradiation and stable without steroid requirement for ≥2 months or following ≥2 prior CNS treatments with stereotactic radiotherapy whole brain irradiation and stable without steroid requirement for ≥4 months.
- Patients must be off all "statin" drugs for ≥ 2 weeks prior to initiation of therapy.
- Age ≥18 years.
- ECOG performance status (PS) 0-1.
- Estimated \>4 month survival probability.
- Normal organ and marrow function as defined below:
- Absolute granulocyte count ≥1,500/mm3 Absolute lymphocyte count ≥500/mm3 Platelets ≥100,000/mm3 Total bilirubin ≤2 mg/dL AST(SGOT)/ALT(SGPT) ≤2x institutional upper limit of normal Creatinine \<1.5 mg/dL
- Ability to understand and the willingness to sign a written informed consent document.
- Negative pregnancy test.
Exclusion
- Surgery involving general anesthesia, chemotherapy, radiotherapy, steroid therapy, or immunotherapy within 4 weeks prior to entering the study. Collection of lumenal tissue must be avoided.
- Patient must not have received any other investigational agents within 30 days prior to study entry.
- Patients with known active or symptomatic brain metastases.
- Patients with compromised pulmonary disease.
- Short term (\<30 days) concurrent systemic steroids ≤ 0.25 mg/kg prednisone per day (maximum 7.5 mg/day) and bronchodilators (inhaled steroids) are permitted; other steroid regimens and/or immunosuppressives are excluded. Patients requiring steroids following previous CNS radiation for metastatic disease are excluded.
- Prior splenectomy.
- Prior malignancy (excluding nonmelanoma carcinomas of the skin) unless in remission for 2 years.
- Kaposi's Sarcoma.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients who are pregnant or nursing.
- Patients with known HIV.
- Patients with chronic Hepatitis B and C infection.
- Patients with uncontrolled autoimmune diseases.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2016
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01453361
Start Date
October 1 2011
End Date
March 22 2016
Last Update
May 24 2018
Active Locations (1)
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1
Mary Crowley Cancer Research Centers
Dallas, Texas, United States, 75230