Vaccine Therapy in Treating Patients With Advanced Kidney Cancer

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

dendritic cell vaccine therapy

conventional surgery

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer, recurrent renal cell cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically confirmed metastatic renal cell carcinoma Evaluable or bidimensionally measurable disease with primary renal tumor in place or surgically accessible metastatic site greater than 2 x 2 cm Over 18 ECOG 0-1 Hematopoietic: Hemoglobin at least 10 g/dL (not transfusion dependent) Platelet count at least 75,000/mm3 WBC greater than 3,000/mm3 Hepatic: SGOT/SGPT no greater than 5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN PT/PTT no greater than 1.5 times ULN Bilirubin no greater than 2.5 mg/dL Renal: Creatinine no greater than 2.0 g/dL Hepatitis B surface antigen negative Negative pregnancy test Fertile patients must use effective contraception At least 4 weeks since prior immunotherapy At least 4 weeks since prior chemotherapy At least 4 weeks since prior radiotherapy At least 14 days since prior acute therapy for infection Exclusion Criteria: uncontrolled CNS metastasis ischemic heart disease that precludes surgery pulmonary condition that precludes surgery other underlying condition or allergy that would preclude study acute viral, bacterial, or fungal infection requiring therapy HIV negative pregnant or nursing other acute medical problems that would preclude study concurrent corticosteroids (oral, topical, inhaled) prior organ allografts

Sites / Locations

Jonsson Comprehensive Cancer Center, UCLA

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004880

First Posted

March 7, 2000

Last Updated

July 30, 2020

Sponsor

Jonsson Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00004880

Brief Title

Vaccine Therapy in Treating Patients With Advanced Kidney Cancer

Official Title

A Phase I Pilot Trial of a Multi-Antigen Loaded Dendritic Cell Vaccine for the Treatment of Advanced Renal Cell Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

June 1997 (undefined)

Primary Completion Date

April 2001 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jonsson Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have advanced kidney cancer.

Detailed Description

OBJECTIVES: I. Evaluate the safety of multiantigen loaded dendritic cells (DC) vaccine in patients with advanced renal cell carcinoma. II. Evaluate the immunologic response to this regimen in this patient population. III. Evaluate the clinical response to this regimen in this patient population. OUTLINE: This is a sequential cohort study. All patients undergo total nephrectomy to harvest primary tumor for vaccine preparation. Patients without primary tumor undergo surgical resection of the accessible metastatic site for vaccine preparation. Patients are assigned to 1 of 4 treatment arms. Arm I: Patients receive vaccination with irradiated autologous tumor lysate (TuLy) intradermally (ID) on day 0 followed by vaccination with multiantigen liposome loaded dendritic cells (DC) ID on days 7, 14, and 21. Arm II: Patients receive vaccinations as in arm I, except DC are pulsed with tumor cells. Arm III: Patients receive vaccination with irradiated autologous tumor lysate (TuLy) IV on day 0 followed by vaccination with multiantigen liposome loaded DC IV on days 7, 14, and 21. Arm IV: Patients receive vaccinations as in arm III, except DC are treated as in arm II. Patients are followed on days 28, 42, 70, and 112. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Cancer

Keywords

stage IV renal cell cancer, recurrent renal cell cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

dendritic cell vaccine therapy

Intervention Type

Procedure

Intervention Name(s)

conventional surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Histologically confirmed metastatic renal cell carcinoma Evaluable or bidimensionally measurable disease with primary renal tumor in place or surgically accessible metastatic site greater than 2 x 2 cm Over 18 ECOG 0-1 Hematopoietic: Hemoglobin at least 10 g/dL (not transfusion dependent) Platelet count at least 75,000/mm3 WBC greater than 3,000/mm3 Hepatic: SGOT/SGPT no greater than 5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN PT/PTT no greater than 1.5 times ULN Bilirubin no greater than 2.5 mg/dL Renal: Creatinine no greater than 2.0 g/dL Hepatitis B surface antigen negative Negative pregnancy test Fertile patients must use effective contraception At least 4 weeks since prior immunotherapy At least 4 weeks since prior chemotherapy At least 4 weeks since prior radiotherapy At least 14 days since prior acute therapy for infection Exclusion Criteria: uncontrolled CNS metastasis ischemic heart disease that precludes surgery pulmonary condition that precludes surgery other underlying condition or allergy that would preclude study acute viral, bacterial, or fungal infection requiring therapy HIV negative pregnant or nursing other acute medical problems that would preclude study concurrent corticosteroids (oral, topical, inhaled) prior organ allografts

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barbara J. Gitlitz, MD

Organizational Affiliation

Jonsson Comprehensive Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

Jonsson Comprehensive Cancer Center, UCLA

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095-1781

Country

United States

Kidney Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial