Immunotherapy Study for Metastatic Renal Cell Cancer
|ClinicalTrials.gov Identifier: NCT02035358|
Recruitment Status : Active, not recruiting
First Posted : January 14, 2014
Last Update Posted : September 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Renal Cell Carcinoma Metastatic Clear-cell Renal Cancer Recurrent Renal Cell Carcinoma Refractory Renal Cell Carcinoma Metastatic Kidney Cancer||Biological: HyperAcute®-Renal (HAR) Immunotherapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of HyperAcute-Renal (HAR) Immunotherapy In Patients With Metastatic Renal Cell Cancer|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||October 2016|
Experimental: HyperAcute®-Renal Immunotherapy
Cells will be injected intradermally every 1 week x 4 weeks and then every 2 weeks for 10 immunizations to total 14 immunizations. Dose Cohort 1 will receive 150 million cells per immunization; Dose Cohort 2 will receive 300 million cells per immunization. Once the first three months of immunizations are completed, patients may receive other systemic treatment (non-investigational) while continuing to receive the remaining 6 immunizations.
Biological: HyperAcute®-Renal (HAR) Immunotherapy
HyperAcute®-Renal Immunotherapy consisting of equal cell doses of each of two allogeneic renal cell cancer cell lines (HAR1 and HAR2) engineered to express the murine α(1,3)GT gene.
Cells will be injected intradermally every 1 week x 4 weeks and then every 2 weeks for 10 immunizations to total 14 immunizations. Dose Cohort 1 will receive 150 million cells per immunization; Dose Cohort 2 will receive 300 million cells per immunization.
- Toxicity [ Time Frame: 3 months ]To determine the toxicity (side-effects, dose-limiting toxicity [DLT] and maximum tolerated dose [MDT]) of administration of HyperAcute®- Renal (HAR) immunotherapy cells administered by intradermal injection into patients with recurrent or refractory, metastatic clear-cell renal cancer.
- Immunological Correlative Studies [ Time Frame: 3 months ]To conduct correlative scientific studies of patient samples to determine the mechanism of any observed anti-tumor effect. In these studies human humoral and cellular immune responses to HAR cells will be evaluated in blood specimens pre and post immunotherapy for microenvironmental immune modulation.
- Progression-Free Survival [ Time Frame: 3 months ]To assess the tumor response rate (progression-free survival) of anti-tumor immunization with HyperAcute®-Renal.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035358
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|United States, Maryland|
|John Hopkins University|
|Baltimore, Maryland, United States, 21205|
|United States, Utah|
|Univeristy of Utah|
|Salt Lake City, Utah, United States, 84112|
|Study Director:||Nicholas Vahanian, MD||NewLink Genetics Incorporation|