Clinical trial · Interventional
A Neoadjuvant Study of Androgen Ablation Combined With Cyclophosphamide and GVAX Vaccine for Localized Prostate Cancer
A Neoadjuvant Immunologic Study of Androgen Deprivation Therapy Combined With a Granulocytemacrophage-colony Stimulating Factor F-secreting Allogeneic Prostate Cancer Vaccine and Low-dose Cyclophosphamide in Men With High-risk Localized Prostate Cancer Undergoing Radical Prostatectomy
NCT01696877CI-TRIAL-00037836completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer Adenocarcinoma in Situ | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| degarelix acetate | Drug | Degarelix | ALIAS |
| GVAX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Degarelix
- description
- Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg at 14 (±3) days prior to surgery. A telephone follow-up interview (or an in-person clinic visit) to evaluate for adverse events will occur 28 (±21) days after prostatectomy. Patients will then be followed by their urologists according to standard institutional practices, but will require prostate-specific antigen evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.
- interventionNames
- Drug: degarelix acetate
- type
- EXPERIMENTAL
- label
- Cyclophosphamide, GVAX and Degarelix
- description
- Cyclophosphamide will be given at a dose of 200 mg/m2 as a single intravenous infusion. 1 day later, prostate GVAX will be administered as five 0.8-mL intradermal injections of PC3 (2.5 × 108 cells) and five 0.5-mL intradermal injections of LNCaP (2.5 × 108 cells), for a total dose of 5 × 108 cells. On day 14, Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.