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A Phase II Study Of Autologous Tumor/DC Vaccine (DC Vaccine) Combined With Interleukin-2 (IL-2) And Interferon-α-2a (IFNα-2a) In Patients With Metastatic Renal Cell Carcinoma (RCC)


Phase 2
18 Years
N/A
Not Enrolling
Both
Kidney Cancer

Thank you

Trial Information

A Phase II Study Of Autologous Tumor/DC Vaccine (DC Vaccine) Combined With Interleukin-2 (IL-2) And Interferon-α-2a (IFNα-2a) In Patients With Metastatic Renal Cell Carcinoma (RCC)


OBJECTIVES:

Primary

- Determine the clinical response rate in patients with metastatic renal cell carcinoma
treated with autologous dendritic cells (DC) loaded with autologous tumor lysate (DC
vaccine) in combination with interleukin-2 and interferon-alfa.

- Determine the toxicity of this regimen in these patients.

Secondary

- Determine, within relevant immune pathways, the treatment-related, tumor-specific
immune response in patients treated with this regimen.

- Correlate tumor-specific immune response with objective clinical response in patients
treated with this regimen.

OUTLINE:

- Induction therapy: Patients undergo leukapheresis on day -9. Patients receive
autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) by
intranodal injection on days 0 and 14; interleukin-2 (IL-2) IV continuously on days 1-5
and 15-19; and interferon-alfa (IFN-α) subcutaneously (SC) once daily on days 1, 3, 5,
15, 17, and 19.

- Maintenance therapy: Patients undergo leukapheresis on days 33, 61, and 89. Patients
receive DC vaccine by intranodal injection on days 42, 70, and 98; IL-2 IV continuously
on days 43-47, 71-75, and 99-103; and IFN-α SC once daily on days 43, 45, 47, 71, 73,
75, 99, 101, and 103.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 18-33 patients will be accrued for this study.


Inclusion Criteria:



- Histologically confirmed metastatic renal cell carcinoma with measurable disease.

- Tumor tissue available and properly stored for lysate preparation.

- Patients must be at least 4 weeks from their last immunotherapy, radiation, surgery
or chemotherapy (6 weeks for nitrosureas) and recovered from all ill effects.

- Karnofsky Performance Status ≥60%

- Life expectancy ≥ twelve weeks

- Adequate end organ function:

- Hematological: ANC ≥ 1000cells/μL, platelets ≥ 75,000/μL, hemoglobin ≥ 8.5 g/dl

- Liver: AST < 2 x ULN (upper limit of normal) unless due to metastases then < 5 x ULN,
serum total bilirubin < 2 x ULN (except for patients with Gilbert's Syndrome)

- Renal: serum creatinine < 2.0 x ULN.

- Pulmonary: FEV1 > 2.0 liters or > 75% of predicted for height and age.

- Cardiac: No evidence of congestive heart failure, symptoms of coronary artery
disease, myocardial infarction less than 6 months prior to entry, or serious cardiac
arrhythmias. Patients over 40 or have had previous myocardial infarction greater than
6 months prior to entry will be required to have a negative or low probability
cardiac stress test for cardiac ischemia.

- CNS: No history of brain metastases.

- Women should not be lactating and, if of childbearing age, have a negative pregnancy
test within two weeks of entry to the study.

- Appropriate Contraception in both sexes

EXCLUSION CRITERIA:

- Patients may have not have been treated previously with IL-2, IFNα or autologous
vaccine.

- Concomitant second malignancy except for non-melanoma skin cancer, and non- invasive
cancer such as cervical CIS, superficial bladder cancer without local recurrence,
breast CIS.

- In patients with a prior history of invasive malignancy, less than five years in
complete remission

- Positive serology for HIV, hepatitis B or hepatitis C,

- Significant co-morbid illness such as uncontrolled diabetes or active infection that
would preclude treatment on this regimen.

- Use of corticosteroids or other immunosuppression (if patient had been taking
steroids, at least 4 weeks must have passed since the last dose).

- History of autoimmune disease.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical Response as Measured by RECIST Monthly and Then Every 2-3 Months

Outcome Description:

A total of 18 evaluable patients will be accrued in the first stage. If 4 or fewer responses are observed in the first stage, the trial will be stopped early, otherwise an additional 15 evaluable patients will be accrued for a total of 33 evaluable patients. If 11 or more responses are observed among the 33 patients, the experimental regimen will be considered for further study, otherwise it will be rejected. The trial will not proceed to the second stage unless at least 5 responses are observed in the first stage.

Outcome Time Frame:

If 4 or fewer responses are observed in the first stage, the trial will be stopped

Safety Issue:

No

Principal Investigator

Marc S. Ernstoff, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Norris Cotton Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000370794

NCT ID:

NCT00085436

Start Date:

December 2003

Completion Date:

October 2009

Related Keywords:

  • Kidney Cancer
  • recurrent renal cell cancer
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical CenterLebanon, New Hampshire  03756-0002