Status:
TERMINATED
Randomized Phase II Adjuvant Chemotherapy ± FANG™ in Colorectal Carcinoma With Liver Metastases
Lead Sponsor:
Gradalis, Inc.
Conditions:
Colon Cancer
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 colorectal carcinoma with synchronous or metachronous liver metastases +/- pulmonary metastases.
- Part 1 patients: May have multiple number of metastatic lesions as long as they can be rendered no evidence of disease (NED).
- Part 2 patients: Maximum total number of metastatic lesions \</= 6. (Patients with CLM with EHD other than lung will be evaluated on an individual basis by the sponsor).
- For patients with 1 but up to 3 total lesions, distribution must include both liver + pulmonary metastases.
- For patients with 4-6 total lesions, distribution may include liver +/- pulmonary metastases.
- Candidate for surgical excision +/= ablation with curative intent based on pre-operative assessment incorporating a CT/PET scan.
- Has been informed of all alternative ≥ first and/or 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.
- Planned resected viable tumor in sufficient quantity ("golf ball size" estimated weight \~ 30 grams) for vaccine processing.
- Recovered to ≤ Grade 1 (excluding alopecia) from all clinically relevant toxicities related to prior therapies.
- Patients must be off all "statin" drugs for ≥ 2 weeks prior to initiation of therapy.
- Age ≥18 years.
- ECOG performance status (PS) 0-2.
- 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, radiotherapy, steroid therapy, or immunotherapy within 4 weeks prior to entering the study. Collection of lumenal tissue must be avoided.
- Prior therapeutic chemotherapy (excluding protocol defined sandwich chemotherapy). Prior approved sandwich / adjuvant therapy is permitted maximum of 3 cycles (1 cycle = 2 biweekly courses / 1 month) anterior therapy and at least 6 months between cessation of chemotherapy and the diagnosis of metastatic disease.
- Prior surgical resection, ablation or radiation therapy for metastatic disease prior to or at the time of tissue procurement.
- Portal, celiac or periaortic metastases.
- Patient must not have received any other investigational agents within 30 days prior to study entry/ registration.
- Patients with known active or symptomatic brain metastases.
- Patients with compromised pulmonary disease.
- Short term (\<30 days) concurrent systemic steroids ≤ 0.125 mg/kg prednisone per day (maximum 10 mg/day) and bronchodilators (inhaled steroids) are permitted; other steroid regimens and/or immunosuppressives 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 with known HIV.
- Patients with chronic Hepatitis B and C infection.
- Patients with uncontrolled autoimmune diseases.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01505166
Start Date
March 1 2012
End Date
August 1 2016
Last Update
November 1 2021
Active Locations (1)
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1
Mary Crowley Cancer Research Centers
Dallas, Texas, United States, 75230