Trials Sponsors Conditions Drugs Pricing

Conditions

Metastatic Clear-cell Renal Cancer Metastatic Kidney Cancer Metastatic Renal Cell Carcinoma Recurrent Renal Cell Carcinoma Refractory Renal Cell Carcinoma

Keywords

MetastaticRecurrentRefractoryRenal Cell CarcinomaKidneyclear-cell renal cancerCancer

Outcome Measures

Primary Outcomes (1)

Percentage of patients with adverse events
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.
3 months

Secondary Outcomes (2)

Immunological Correlative Studies
3 months
Progression-Free Survival
3 months

Study Arms (1)

HyperAcute®-Renal Immunotherapy

EXPERIMENTAL

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

Interventions

HyperAcute®-Renal (HAR) ImmunotherapyBiological

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.

Also known as: HyperAcute®-Renal, HAR

HyperAcute®-Renal Immunotherapy

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

years or older
Signed written informed consent

Sponsors & Collaborators

NewLink Genetics Corporation
Industrylead

Study Sites (3)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

John Hopkins University

Baltimore, Maryland, 21205, United States

Univeristy of Utah

Salt Lake City, Utah, 84112, United States

Related Publications (1)

Hahn AW, Drake C, Denmeade SR, Zakharia Y, Maughan BL, Kennedy E, Link C Jr, Vahanian N, Hammers H, Agarwal N. A Phase I Study of Alpha-1,3-Galactosyltransferase-Expressing Allogeneic Renal Cell Carcinoma Immunotherapy in Patients with Refractory Metastatic Renal Cell Carcinoma. Oncologist. 2020 Feb;25(2):121-e213. doi: 10.1634/theoncologist.2019-0599. Epub 2019 Sep 6.
PMID: 32043778DERIVED

MeSH Terms

Conditions

Carcinoma, Renal CellKidney NeoplasmsNeoplasm MetastasisRecurrenceNeoplasms

Interventions

cell-surface retention-binding protein 1Immunotherapy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by Site

Enrollment

18 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 14, 2014

Study Start

May 2015

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

Age \<18-years-old.
Active CNS metastases or carcinomatous meningitis. Patients with CNS lesions that have been treated and who have no evidence of progression in the brain on CT/MRI for ≥1 month are eligible.
Pregnant or nursing women due to the unknown effects of immunization on the developing fetus or newborn infant.
Other malignancy within five years, except that the following may be eligible:
patients curatively treated for localized squamous or basal cell carcinoma of the skin or for carcinoma in situ of the uterine cervix (CIN) or breast,
Patients with a history of malignant tumor who have been disease free for at least five years and are not currently being treated.
History of an allogeneic solid organ transplant or bone marrow transplant, or current active immunosuppressive therapy such as cyclosporine, tacrolimus, etc.
Subjects taking systemic (parentally or orally) corticosteroid therapy for any reason, including replacement therapy for hypoadrenalism, are not eligible. Topical steroids are acceptable as are intranasal steroids.
Active infection or antibiotics within 48 hours prior to study enrollment, including unexplained fever (temp \> 38.1°C), if deemed clinically significant by the treating physician.
Evidence of active autoimmune disease (e.g., systemic lupus erythematosis, rheumatoid arthritis, with the exception of vitiligo. Patients with a remote history of asthma or mild asthma are eligible.
Other serious medical conditions that may be expected to limit life expectancy to less than 1 year (e.g., liver cirrhosis).
Any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc).
Patients having previously undergone splenectomy.
Patients with known hepatitis or unstable liver disease, and/or positive serologies for Hepatitis B or C and HIV.
Patients with sickle-cell anemia or thalassemia major.
+11 more criteria

Immunotherapy Study for Metastatic Renal Cell Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

HyperAcute®-Renal Immunotherapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

HyperAcute®-Renal Immunotherapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations