A Neoadjuvant Study of Androgen Ablation Combined With Cyclophosphamide and GVAX Vaccine for Localized Prostate Cancer

• Status: Completed
• Trial end date: 2018-12-18
• Target enrollment: 0
• Participant gender: Male

Summary

This research is being done to see if an investigational prostate cancer vaccine, called GVAX, can safely be given together with a single intravenous injection of a drug called cyclophosphamide to men that will undergo surgery to remove their cancerous prostate glands who have also received standard hormonal therapy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: BioSante Pharmaceuticals; David H. Koch Charitable Foundation
• Treatments: Androgens; Cyclophosphamide; Molgramostim; Sargramostim; Vaccines

Criteria

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the prostate (clinical stage T1c-T3b, N0, M0) without involvement of lymph nodes, bone, or visceral organs

• Initial prostate biopsy is available for central pathologic review, and is confirmed to show at least 2 positive cores and a maximum Gleason sum of ≥ 7

• Radical prostatectomy has been scheduled at Johns Hopkins Hospital

• Age ≥ 21 years

• Eastern Cooperative Oncology Group performance status 0-1, or Karnofsky score ≥ 70%

• Adequate bone marrow, hepatic, and renal function:

• White Blood Count > 3,000 cells/mm3

• Absolute neutrophil count > 1,500 cells/mm3

• Hemoglobin > 9.0 g/dL

• Platelet count > 100,000 cells/mm3

• Serum creatinine < 2.0 mg/dL

• Serum bilirubin < 2 mg/dL

• Alanine aminotransferase < 2 × upper limit of normal (ULN)

• Aspartate aminotransferase < 2 × ULN

• Alkaline phosphatase < 2 × ULN

• Willingness to provide written informed consent and HIPAA authorization for the release of personal health information, and the ability to comply with the study requirements (note: HIPAA authorization will be included in the informed consent)

• Willingness to use barrier contraception from the time of cyclophosphamide and/or GVAX administration until the time of prostatectomy.

Exclusion Criteria:

• Presence of known lymph node involvement or distant metastases

• Other histologic types of prostate cancers such as ductal, sarcomatous, lymphoma, small cell, and neuroendocrine tumors

• Prior radiation therapy, hormonal therapy, biologic therapy, or chemotherapy for prostate cancer

• Prior immunotherapy/vaccine therapy for prostate cancer

• Previous or concurrent use of cyclophosphamide

• Concomitant treatment with other hormonal therapy or 5a-reductase inhibitors

• Current use of systemic corticosteroids or use of corticosteroids within 4 weeks of enrollment (inhaled corticosteroids for asthma or Chronic obstructive pulmonary disease are permitted)

• Use of experimental agents for prostate cancer within the past 3 months

• Known allergy to cyclophosphamide or G-colony stimulating factor /granulocytemacrophage-colony stimulating factor

• Known hypersensitivity to materials of bovine origin (e.g. fetal bovine serum), or other components of GVAX which include Dimethyl sulfoxide and hydroxyethyl starch as well as small amounts of porcine trypsin and DNase

• History or presence of autoimmune disease requiring systemic immunosuppression (including but not limited to: inflammatory bowel disease, systemic lupus erythematosus, vasculitis, rheumatoid arthritis, scleroderma, multiple sclerosis, hemolytic anemia, Sjögren syndrome, and sarcoidosis)

• Other concurrent malignancies, with the exception of non-melanoma skin cancers and superficial bladder cancer

• Uncontrolled major active infectious, cardiovascular, pulmonary, hematologic, or psychiatric illnesses that would make the patient a poor study candidate

• Known prior or current history of HIV and/or hepatitis B/C