Vaccine Therapy in Treating Patients With Kidney Cancer

NCT00014131 | Terminated Phase 1

• 3 other identifiers: CDR0000068493HOAG-VACCINE-RNNCI-V01-1647
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have recurrent or stage III or stage IV kidney cancer.

Conditions

Kidney Cancer

Keywords

stage III renal cell cancer; stage IV renal cell cancer; recurrent renal cell cancer

Outcome Measures

Primary Outcomes (5)

• Conversion of the delayed-type hypersensitivity (DTH) skin test as measured by metric skin ruler at week 4 and month 6 during vaccine therapy

  week 4 and month 6 during vaccine therapy

• Tumor response (partial response or complete response) as measured by RECIST at months 2 or 3 and 6 during study treatment, and 6 months after study completion

  months 2 or 3 and 6 during study treatment, and 6 months after study completion

• Progression-free survival as measured by RECIST at months 2 or 3 and 6 during study treatment and every 6 months after study completion

  months 2 or 3 and 6 during study treatment and every 6 months after study completion

• Event-free survival as measured by RECIST at months 2 or 3 and 6 during study treatment and every 6 months after study completion

  months 2 or 3 and 6 during study treatment and every 6 months after study completion

• Overall survival beginning at the date of study entry

  5 years or until death, whichever came first.

Study Arms (1)

Biological/Vaccine

EXPERIMENTAL

Biological/Vaccine: therapeutic autologous dendritic cells. Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product.

Biological: Biological/Vaccine: therapeutic autologous dendritic cells.

Interventions

Biological/Vaccine: therapeutic autologous dendritic cells. BIOLOGICAL

Biological/Vaccine: therapeutic autologous dendritic cells. Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product.

Biological/Vaccine

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma * Stage III or IV disease involving invasions beyond Gerota's fascia, regional lymph node involvement, or distant metastases OR * Recurrent disease involving lymph node metastases or soft tissue nodules * Measurable disease by anatomic-based radiological tests (unless no evidence of disease as documented by prior surgery) * Planned resection of tumor to establish an autologous tumor cell line * No active CNS metastases such as brain metastases, spinal cord compression, or leptomeningeal disease * Prior brain metastases or spinal cord compression allowed provided there is radiographic evidence of lack of progression and no requirement for pharmacologic doses of corticosteroids PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * ECOG 0-2 Life expectancy: * At least 4 months Hematopoietic: * Hematocrit greater than 25% * Platelet count greater than 100,000/mm3 * No ongoing transfusion requirements * No active blood clotting or bleeding diathesis Hepatic: * Bilirubin no greater than 2.0 mg/dL * Albumin at least 3.0 g/dL * No significant hepatic dysfunction Renal: * Creatinine no greater than 2.0 mg/dL * No significant renal dysfunction Cardiovascular: * No underlying cardiac disease associated with New York Heart Association class III or IV heart function * No unstable angina related to atherosclerotic cardiovascular disease Other: * No other malignancy within the past 5 years except carcinoma in situ, basal cell or localized squamous cell skin cancer, or localized prostate cancer * No active infection * No other active medical condition that could be eminently life threatening * Not pregnant * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Other prior putative vaccines allowed * Recovered from prior biologic therapy * No concurrent biologic therapy except epoetin alfa for patients with hematocrit less than 36% Chemotherapy: * At least 3 weeks since prior chemotherapy and recovered * No concurrent chemotherapy Endocrine therapy: * See Disease Characteristics * No concurrent corticosteroids Radiotherapy: * At least 3 weeks since prior radiotherapy (including whole-brain radiotherapy) and recovered * No concurrent radiotherapy Surgery: * See Disease Characteristics * Recovered from prior surgery Other: * Concurrent bisphosphonates allowed for patients with lytic bone metastases * No concurrent digoxin or other medications designed to improve cardiac output * No other concurrent anticancer therapy or investigational therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Lisata Therapeutics, Inc.: lead

Study Sites (1)

Hoag Cancer Center at Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Biological Products

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

• Robert O. Dillman, MD, FACP

  Hoag Memorial Hospital Presbyterian

  STUDY CHAIR

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: April 10, 2001
• First Posted: January 27, 2003
• Study Start: November 1, 2001
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: October 4, 2023

Record last verified: 2023-10

Locations

US (1)