Randomized Phase II Adjuvant Chemotherapy ± FANG™ in Colorectal Carcinoma With Liver Metastases (FANG-CLM)
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ClinicalTrials.gov Identifier: NCT01505166 |
Recruitment Status
:
Completed
First Posted
: January 6, 2012
Last Update Posted
: August 4, 2017
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Condition or disease | Intervention/treatment | Phase |
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Colon Cancer | Biological: Vigil™ Vaccine Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Randomized Phase II Trial of Post-operative Adjuvant Chemotherapy ± FANG™ Autologous Tumor Cell Vaccine in Colorectal Carcinoma With Liver Metastases |
Study Start Date : | March 2012 |
Actual Primary Completion Date : | August 2016 |
Actual Study Completion Date : | August 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: Vigil™
Patients will receive 1 x 10^7 cells (Group A) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses (vaccine) starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.
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Biological: Vigil™ Vaccine
Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).
Other Name: formerly known as FANG™
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Placebo Comparator: Placebo
Patients will receive placebo (Group B) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.
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Drug: Placebo
Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).
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Experimental: Vigil™ Vaccine (6 patient run-in)
Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations).
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Biological: Vigil™ Vaccine
Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).
Other Name: formerly known as FANG™
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- Overall Survival Rate [ Time Frame: 24 Months ]To determine the overall survival rate in patients with CLM following resection +/= ablation with curative intent treated with adjuvant chemotherapy and Vigil™ vaccine versus adjuvant chemotherapy and placebo and compare with historical data
- Immune Response [ Time Frame: baseline, Month 2, 3, and 4 ]To evaluate and correlate TIL in (initial) excised tumor and ELISPOT responses to Vigil™ vaccine in patients with CLM.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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).
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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.
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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 Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505166
United States, Texas | |
Mary Crowley Cancer Research Centers | |
Dallas, Texas, United States, 75230 |
Principal Investigator: | Minal Barve, MD | Mary Crowley Cancer Research Centers |
Publications:
Responsible Party: | Gradalis, Inc. |
ClinicalTrials.gov Identifier: | NCT01505166 History of Changes |
Other Study ID Numbers: |
CL-PTL 107 |
First Posted: | January 6, 2012 Key Record Dates |
Last Update Posted: | August 4, 2017 |
Last Verified: | August 2017 |
Keywords provided by Gradalis, Inc.:
colorectal carcinoma colon cancer liver metastases |
Additional relevant MeSH terms:
Carcinoma Neoplasm Metastasis Colonic Neoplasms Colorectal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplastic Processes Pathologic Processes Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Vaccines Modafinil Armodafinil Immunologic Factors Physiological Effects of Drugs Wakefulness-Promoting Agents Central Nervous System Stimulants Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action |