Phase II Study of a B7-1 Gene-Modified Autologous Tumor Cell Vaccine and Systemic IL-2

NCT00031564 | Completed Phase 2

• 4 other identifiers: MCC-12207NCI-5090NCI-G00-18720001386
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made by inserting a laboratory-treated gene into a person's tumor cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining vaccine therapy with interleukin-2 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with interleukin-2 in treating patients who have stage IV kidney cancer.

Conditions

Kidney Cancer

Keywords

stage IV; renal cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Who Have a Reduction in the Size of Their Measurable Metastatic Tumors

  The primary objective of this phase II trial involving 30 patients will be to determine tumor response rates. The immunogenicity of the treatment will be assessed by ELISPOT assays performed on the patients' peripheral blood lymphocytes, and by an immunohistochemical analysis of DTH skin tests site biopsies performed 48 hours after the intradermal injection of autologous, unmodified tumor cells.

  4 years

Study Arms (1)

Vaccine Therapy With Interleukin-2

EXPERIMENTAL

At approximately 3-6 weeks after surgery, patients receive B7-1 gene-modified autologous tumor cell vaccine subcutaneously (SC) once on days 1, 29, and 57. At 6 weeks after the first vaccination, patients receive interleukin-2 (IL-2) SC five days a week for 6 weeks (days 43-82). Patients with stable or responding disease after day 106 may receive additional vaccinations in the absence of disease progression or unacceptable toxicity.

Biological: Interleukin-2; Biological: B7-1

Interventions

Interleukin-2 BIOLOGICAL

Also known as: Aldesleukin, IL-2

Vaccine Therapy With Interleukin-2

B7-1 BIOLOGICAL

Also known as: gene-modified autologous tumor cell vaccine

Vaccine Therapy With Interleukin-2

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed stage IV renal cell carcinoma * Symptomatic primary tumor or resectable metastasis * Measurable disease post resection * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Eastern Cooperative Oncology Group (ECOG) 0-1 Life expectancy: * Not specified Hematopoietic: * WBC greater than 4,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 10 g/dL * Hematocrit greater than 30% Hepatic: * Bilirubin less than 2 times normal * SGOT less than 3 times normal Renal: * Creatinine less than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * No evidence of active myocardial ischemia, prior myocardial infarction, or arrhythmia Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No contraindications to surgical resection * No history of immunodeficiency disease * No known allergy to penicillin PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior interleukin-2, interferon alfa, or other biologic agent allowed Chemotherapy: * Not specified Endocrine therapy: * No concurrent corticosteroids (except for replacement doses for adrenal insufficiency) Radiotherapy: * Not specified Surgery: * See Disease Characteristics Other: * No concurrent immunosuppressants

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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Cancer Institute (NCI): collaborator
• Chiron Corporation: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Publications (1)

• Fishman M, Hunter TB, Soliman H, Thompson P, Dunn M, Smilee R, Farmelo MJ, Noyes DR, Mahany JJ, Lee JH, Cantor A, Messina J, Seigne J, Pow-Sang J, Janssen W, Antonia SJ. Phase II trial of B7-1 (CD-86) transduced, cultured autologous tumor cell vaccine plus subcutaneous interleukin-2 for treatment of stage IV renal cell carcinoma. J Immunother. 2008 Jan;31(1):72-80. doi: 10.1097/CJI.0b013e31815ba792.

  PMID: 18157014 RESULT

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Interleukin-2; aldesleukin; B7-1 Antigen

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; B7 Antigens; Membrane Proteins; Antigens, Surface; Antigens

Study Officials

• Scott J. Antonia, M.D., Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

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: March 8, 2002
• First Posted: January 27, 2003
• Study Start: May 1, 2000
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2012
• Last Updated: September 27, 2012

Record last verified: 2012-09

Locations

US (1)