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

Completed · Phase 1/Phase 2

Conditions studied: Prostate Cancer Adenocarcinoma in Situ

In brief

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.

Key facts

Study ID: NCT01696877
Run by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
People needed: 29
Starts: 2013-01-18
Expected to finish: 2018-12-18
Last updated by the study team: 2019-03-28

Who can join

Age: 21 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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