Autologous Dendritic Cells in Treating Patients With Metastatic Kidney Cancer

NCT01826877 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: 12-000577NCI-2013-00646
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial studies the side effects and best dose of autologous dendritic cells in treating patients with metastatic kidney cancer. Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells.

Conditions

Clear Cell Renal Cell Carcinoma; Recurrent Renal Cell Cancer; Stage IV Renal Cell Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events including all grade 3 and grade 4 adverse events regardless of causality, treatment-related adverse events, dose limiting toxicities (DLT), and adverse events leading to discontinuation of study treatment

  Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03

  Up to day 57

Secondary Outcomes (7)

• CAIX-specific immune response

  Up to 3 years

• Objective response (CR, PR) according to RECIST guideline version 1.1

  Up to 3 years

• Duration of progression-free survival

  Up to 3 years

• Clinical benefit rate (CR, PR, and SD) greater than or equal to 12 weeks

  Up to 3 years

• Disease response (CR, PR, stable disease [SD], and progressive disease [PD]) according to RECIST guideline version 1

  Up to 3 years

Study Arms (1)

Treatment (autologous dendritic cells)

EXPERIMENTAL

Patients receive AdGMCAIX-transduced autologous dendritic cells ID on days 1, 15, and 29.

Biological: AdGMCAIX-transduced autologous dendritic cells; Biological: therapeutic autologous dendritic cells; Other: laboratory biomarker analysis

Interventions

AdGMCAIX-transduced autologous dendritic cells BIOLOGICAL

Given ID

Also known as: DC-AdGMCAIX, dendritic cells transduced with AdGMCA9 expressing GM-CSF-carbonic anhydrase IX fusion protein

Treatment (autologous dendritic cells)

therapeutic autologous dendritic cells BIOLOGICAL

Given ID

Also known as: ADC, autologous dendritic cells

Treatment (autologous dendritic cells)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (autologous dendritic cells)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed clear cell renal cell carcinoma (ccRCC); pathology report from the original diagnosis of renal cell carcinoma is acceptable; the component of conventional clear cell type \> 50% is mandatory
• Evidence of metastatic disease with measurable lesion(s) as defined by RECIST guideline version 1.1 to permit tumor response evaluation; subjects with unresected primary tumors may be enrolled as long as evidence of measurable metastatic disease is also present
• Signed informed consent
• Eastern Cooperative Oncology Group (ECOG) =\< 1
• Expected life expectancy \>= 6 months
• Serum creatinine \< 2 mg/dL
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 X upper limit of normal (ULN)
• Total bilirubin \< 2 X ULN (except for subjects with documented Gilbert's syndrome who can have total bilirubin \< 3.0 mg/dl)
• Hemoglobin \>= 10 g/dL
• Absolute neutrophil count \>= 1.5 X 10\^9 cells/L
• Platelets \>= 100 X 10\^9/L
• Having recovered from prior surgery, radiation, chemotherapy (cytotoxic and noncytotoxic) to toxicity grade =\< 1 or returned to baseline; previous treatment with immunotherapies, cytotoxic drugs, or other targeted agents is permitted; if cytotoxic chemotherapy was previously received, the last dose must be \>= 1 month before leukapheresis; for other agents, the last dose must be \>= 14 days before leukapheresis
• Negative serum pregnancy test within 7 days prior to enrollment in female subjects with reproductive potential

You may not qualify if:

• Rapidly progressing cancer likely to require palliative systemic intervention within 8 weeks after study entry
• Presence of untreated/active central nervous system (CNS) metastases
• For subjects with metastatic RCC who have had no prior systemic treatment for RCC and are considered a poor risk according to Motzer criteria, defined by having \>= 3 of the following 5 risk factors for short survival: Karnofsky performance score \< 80%, lactate dehydrogenase (LDH) \> 1.5 X of ULN, hemoglobin \< lower limit of normal (LLN), corrected serum calcium \> 10 mg/dL (2.5mM), a time from initial diagnosis of RCC to initiation of systemic therapy of \< 1 year
• Non-clear cell or predominantly (\> 50%) sarcomatoid histology
• Concurrent major medical conditions, such as uncontrolled hypertension, diabetes mellitus, ischemic heart disease, chronic obstructive pulmonary disease, autoimmune disease, adrenal insufficiency, or prior allogeneic organ transplant requiring chronic immunosuppressive therapy, including systemic glucocorticoid treatment or replacement therapy
• Active or chronic systemic infection, including viral hepatitis, human immunodeficiency virus (HIV), mycobacteria, tuberculosis (TB), or other opportunistic infections
• Having received systemic immune suppressive therapy within 30 days prior to leukapheresis
• Having received an investigational agent within 30 days prior to the first dose of study treatment
• Female subjects who are lactating, pregnant or both male and female subjects with reproductive potential who refuse to practice medically accepted methods for contraception over the period from study consent to 90 days following the last dose of study treatment
• Other malignancy within 3 years, except for adequately treated non-melanoma skin cancer, non-invasive cancers such as cervical or breast carcinoma in situ, or superficial bladder cancer without local recurrence
• Social or psychological conditions that the investigator judges may compromise study compliance

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Kite, A Gilead Company: collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Faiena I, Comin-Anduix B, Berent-Maoz B, Bot A, Zomorodian N, Sachdeva A, Said J, Cheung-Lau G, Pang J, Macabali M, Chodon T, Wang X, Cabrera P, Kaplan-Lefko P, Chamie K, Belldegrun AS, Pantuck AJ, Drakaki A. A Phase I, Open-label, Dose-escalation, and Cohort Expansion Study to Evaluate the Safety and Immune Response to Autologous Dendritic Cells Transduced With AdGMCA9 (DC-AdGMCAIX) in Patients With Metastatic Renal Cell Carcinoma. J Immunother. 2020 Nov/Dec;43(9):273-282. doi: 10.1097/CJI.0000000000000336.

  PMID: 32925563 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Alexandra Drakaki, MD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 4, 2013
• First Posted: April 9, 2013
• Study Start: January 14, 2013
• Primary Completion: July 3, 2018
• Study Completion: May 27, 2021
• Last Updated: August 4, 2021

Record last verified: 2021-07

Locations

US (1)