DC Vaccine Combined With IL-2 and IFNα-2a in Treating Patients With mRCC

NCT00085436 | Completed Phase 2 Results

• 5 other identifiers: D0238R01CA095648P30CA023108DMS-0238DMS-16090
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from a patient's dendritic cells and tumor cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's lymphocytes to kill kidney cancer cells. Interferon alfa may interfere with the growth of cancer cells. Combining vaccine therapy with interleukin-2 and interferon alfa may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving vaccine therapy together with interleukin-2 and interferon alfa works in treating patients with metastatic renal cell carcinoma (kidney cancer).

Conditions

Kidney Cancer

Keywords

recurrent renal cell cancer; stage IV renal cell cancer

Outcome Measures

Primary Outcomes (1)

• Clinical Response as Measured by RECIST

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  monthly, then every 2-3 months

Secondary Outcomes (1)

• Immunity as Measured by T-cell and Antibody Responses to the Tumor

  monthly for 5 months

Study Arms (1)

Vaccine, Aldesleukin-2, Interferon-a

EXPERIMENTAL

All patients will be treated with autologous tumor cell vaccine administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and recombinant interferon alfa. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.

Biological: Aldesleukin,; Biological: autologous tumor cell vaccine; Biological: recombinant interferon alfa

Interventions

Aldesleukin, BIOLOGICAL

Recombinant human interleukin-2 (Proleukin, Chiron Therapeutics) will be administered as a five day (120 hr) continuous intravenous infusion at a dose of 18x106 IU per square meter of body surface area per day as per the Negrier regimen (21). The treatment schedule consists of two induction cycles and three maintenance cycles. Each induction cycle consists of two five-day courses of interleukin-2 infusion separated by a nine-day break. Each maintenance cycle consists of a five-day infusion followed by 23-day rest period of no therapy.

Also known as: IL-2 (Proleukin®, Chiron)

Vaccine, Aldesleukin-2, Interferon-a

autologous tumor cell vaccine BIOLOGICAL

we will administer 1 X 107 DC cells. The autologous tumor cell vaccine (1 X 107 cells/1cc) in lactated ringers solution and injected into one (or two if clinically necessary) inguinal lymph nodes under ultrasound guidance. Each cycle of DC vaccine will be administered alternately in the right and left inguinal lymph nodes.

Also known as: DC Vaccine

Vaccine, Aldesleukin-2, Interferon-a

recombinant interferon alfa BIOLOGICAL

Recombinant human interferon alfa-2a (Roferon, Roche), at a dose of 6 million IU per day three times a week subcutaneously will be given during the two interleukin-2 induction cycles and during each interleukin-2 maintenance cycle

Also known as: interferon alfa-2a; Roferon

Vaccine, Aldesleukin-2, Interferon-a

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Related Publications (1)

• Schwaab T, Schwarzer A, Wolf B, Crocenzi TS, Seigne JD, Crosby NA, Cole BF, Fisher JL, Uhlenhake JC, Mellinger D, Foster C, Szczepiorkowski ZM, Webber SM, Schned AR, Harris RD, Barth RJ Jr, Heaney JA, Noelle RJ, Ernstoff MS. Clinical and immunologic effects of intranodal autologous tumor lysate-dendritic cell vaccine with Aldesleukin (Interleukin 2) and IFN-alpha2a therapy in metastatic renal cell carcinoma patients. Clin Cancer Res. 2009 Aug 1;15(15):4986-92. doi: 10.1158/1078-0432.CCR-08-3240. Epub 2009 Jul 21.

  PMID: 19622576 RESULT

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

aldesleukin; Interleukin-2; chiron; FANG vaccine; lentiviral minigene vaccine of COVID-19 coronavirus; Interferon-alpha; Interferon alpha-2

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)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Interferon Type I; Interferons

Results Point of Contact

• Title: Dr. Marc S. Ernstoff
• Organization: Dartmouth-Hitchcock Medical Center

marc.s.ernstoff@hitchcock.org

603-650-5534

Study Officials

• Marc S. Ernstoff, MD

  Norris Cotton Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: December 1, 2003
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: June 26, 2018
• Results First Posted: June 10, 2013

Record last verified: 2018-05

Locations

US (1)