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Trial record 12 of 12 for:    allostim

Study Comparing AlloVax™ to Chemotherapy in Recurrent/Metastatic Squamous Cell Carcinoma of the Head & Neck

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ClinicalTrials.gov Identifier: NCT02624999
Recruitment Status : Not yet recruiting
First Posted : December 9, 2015
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
Immunovative Therapies, Ltd.

Brief Summary:
Phase II, Randomized, Non-Inferiority Study Comparing an Individualized Cancer Vaccine (AlloVax™) to Chemotherapy in Subjects with R/M SCCHN .

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma Head and Neck Biological: AlloVax™ Drug: Cisplatin Phase 2

Detailed Description:

All accrued subjects will be randomized 2:1 to AlloVax™ (CRCL + AlloStim™) immunotherapy vs. standard chemotherapy. AlloVax™ is an experimental individualized therapeutic vaccine shown to be active in this study population.

The standard chemotherapy arm (Arm 1) will receive up to six three-week cycles of chemotherapy consisting of cisplatin on day 0 of the 3-week cycle at dose 80-100 mg/m2 IV followed by 1000 mg/m2 IV flurouracil (5FU) on days 1-4 of the cycle.

The immunotherapy arm (Arm 2) will receive immunotherapy (AlloVax™) twice a week for 4 weeks and then every 4 weeks for an additional 12 weeks.

The study is designed and powered to determine if AlloVax™ is not inferior to the active chemotherapy control.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Individualized Cancer Vaccine for Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Study Start Date : December 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arm Intervention/treatment
Experimental: Immunotherapy
Subjects in this arm will receive immunotherapy (AlloVax™: CRCL + AlloStim™) twice a week for 4 weeks and then every 4 weeks for an additional 12 weeks
Biological: AlloVax™
AlloVax™ combines an anti-tumor effect of mini-transplant procedures with patient specific tumor antigens
Other Name: CRCL + AlloStim™

Active Comparator: Standard chemotherapy
Subjects in this arm will receive up to six three-week cycles of chemotherapy consisting of cisplatin on day 0 of the 3-week cycle at dose 80-100 mg/m2 IV followed by 1000 mg/m2 IV 5FU on days 1-4 of the cycle
Drug: Cisplatin
Subjects in the chemotherapy arm will receive up to 6 cycles of cisplatin on day 0 of the 3-week cycle at dose of 80-100 mg/m2 IV and 1000 mg/m2 IV 5FU on days 1-4 of the cycle
Other Name: Standard Chemotherapy




Primary Outcome Measures :
  1. Safety and tolerability (vital signs, physical examination, clinical laboratory profile, adverse events assessed by CTCAE v4.0 and dose limiting toxicity (DLT)) [ Time Frame: 119 days ]
    Whether AlloVax™ is less toxic than chemotherapy. will be evaluated on the basis of the following parameters: vital signs, physical examination, clinical laboratory profile, adverse events assessed by CTCAE v4.0 and dose limiting toxicity (DLT)

  2. Overall Survival [ Time Frame: 119 days ]
    Whether AlloVax™ is not inferior to the active chemotherapy control (from time of randomization). Subjects are followed for survival during the trial and as long as they are alive after the last study treatment through follow-up


Secondary Outcome Measures :
  1. Health related Quality of Life (HRQoL) [ Time Frame: 119 days ]
    QLQ-C30 and QLQ-H&N35 questionnaires


Other Outcome Measures:
  1. RECIST [ Time Frame: 119 days ]
    Response and correlation with pathology assessment

  2. Immune-Related Response Criteria (irRC) [ Time Frame: 119 days ]
    Response and correlation with pathology assessment

  3. Immune response in the treatment arm [ Time Frame: 119 days ]
    Correlation of OS with immune response



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult males and female subjects aged 18 years or older at screening visit.
  • Histopatholologically or cytologically confirmed diagnosis of locoregionally recurrent unresectable or previously untreated metastatic SCCHN.
  • Tumor lesion safely accessible for biopsy or surgical excision resulting in a minimum of 0.2 g of tumor sample for CRCL processing.
  • Subjects must have measurable disease according to revised RECIST v.1.1 guidelines.
  • Eastern Cooperative Oncology Group (ECOG) ≤1.
  • Subjects must be screened to be negative for Human Immunodeficiency Virus 1 (HIV1), HBsAg, Hepatitis C (HCV) and Rapid Plasma Reagin (RPR,syphilis).
  • Subjects must have adequate organ function including: (WBC >3000/mm3, Platelets >100,000/mm3, Absolute neutrophil count ≥ 1,500/mm³, Hemoglobin ≥ 10.0 g/dL (transfusion allowed)), Hepatic (Serum Total bilirubin < 2 x ULN mg/dL, Alanine transaminase (ALT) (SGPT) / Aspartate aminotransferase (AST) (SGOT) ≤3 x upper limit of normal (ULN)), Renal: Serum creatinine (SCR) <2.0 x ULN, or, Creatinine clearance (CCR) >30 mL/min.
  • Pre-study EKG without significant abnormalities.
  • Women of child-bearing potential must have a negative urine or serum pregnancy test result within 72 hours prior to the start of study drug administration.
  • If child producing potential age, must agree to use contraception or avoidance of pregnancy measures while enrolled on study and receiving the experimental product.
  • Ability to understand the study, its inherent risks, side effects and potential benefits and be able to give written informed consent to participate.

Exclusion Criteria:

  • Clinical evidence or radiological evidence of brain metastasis.
  • Treated for another primary cancer within 2 years prior to signing inform consent form.
  • Any concomitant anticancer therapies.
  • History of severe hypersensitivity to monoclonal antibody drugs or any contraindication to any of the study drugs.
  • Concomitant active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, autoimmune thyroid disease, uveitis).
  • Prior experimental therapy or cancer vaccine treatment (e.g., dendritic cell therapy, heat shock vaccine).
  • Clinical requirement for systemic steroids or immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 1 month prior to signing inform consent form.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, requiring parenteral antibiotics, symptomatic congestive heart failure, severe myocardial insufficiency, cardiac arrhythmia. All infections must be resolved and the subject must remain a febrile for seven days prior to being placed in the study.
  • History of blood transfusion reactions.
  • Psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude study participation.
  • Female subject is pregnant or breast-feeding

Information from the National Library of Medicine

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): NCT02624999


Contacts
Contact: Chindavijak Somjin, MD +66 89 6937679 jksomjin@hotmail.com
Contact: Nitiya Ritthidechratn +662 619 13356 nitiya@Immunovative.com

Locations
Thailand
National Cancer Institute of Thailand Not yet recruiting
Bangkok, Thailand, 10400
Contact: Chindavijak Somjin, MD    +66 89 6937679    jksomjin@hotmail.com   
Contact: Nitiya Ritthidechratn    +66261913356    nitiya@immunovative.com   
Principal Investigator: Chindavijak Somjin, MD         
Sponsors and Collaborators
Immunovative Therapies, Ltd.
Investigators
Study Director: Michael Har-Noy, Dr. CEO & CTO

Responsible Party: Immunovative Therapies, Ltd.
ClinicalTrials.gov Identifier: NCT02624999     History of Changes
Other Study ID Numbers: ITL-020-HENK-VAXPII
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016

Keywords provided by Immunovative Therapies, Ltd.:
Head and Neck Cancer
SCCHN
R/M SCCHN
Carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Cisplatin
Antineoplastic Agents