Safety Study of Autologous Dendritic Cells Injected Into the Prostate After Cryoablation for Advanced Prostate Cancer

NCT00753220 | Terminated Phase 1 Results

• 1 other identifier: CRITICAL001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the intra-tumoral injection of a subject's own dendritic cells after cryotherapy of the prostate is a safe and effective treatment for advanced prostate cancer. In theory, the injected dendritic cells will internalize antigens from the tumor cells which have been damaged by cryotherapy and activate the subject's immune system against that specific tumor. Subjects will also receive a low dose chemotherapy designed to lower the number of T-regulatory cells which have been shown to lower or stop some immune system responses. Hypothesis 1: Dendritic cell injection into cryotreated prostate cancer is non-toxic; Hypothesis 2: Dendritic cell injection into cryotreated prostate cancer is medically beneficial to the subject.

Conditions

Prostate Cancer

Keywords

Metastatic; Androgen; Independent; Prostate Cancer; (AIPC),; Hormone-refractory; (HRPC),; cryotherapy,; dendritic cell,; immunotherapy; Chemo-naïve; lymph nodes; bone

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD)

  PROTOCOL EXCERPT: The primary objective of the Phase I Portion of this study is the determination of the maximum tolerated dose (MTD) of intratumorally injected study agent VDC2008 administered following cryoablation of the prostate, and pre- and post-treatment with a low-dose cyclophosphamide therapy, as determined by toxicity and adverse event monitoring following treatment of metastatic androgen-independent prostate cancer. ADDITIONAL INFORMATION: MTD was not reached by any study participant prior to end of the study. Additional participants would have been necessary to determine MTD.

  Up to 1 year

Study Arms (1)

VDC2008

EXPERIMENTAL

Cryoablation of prostate followed by dendritic cell injection (dose of 2.5 x 10\^7, 7.5 x 10\^7, or 1.0 x 10\^8 cells depending on assigned cohort) into prostate and low dose cyclophosphamide therapy (dose: 25 mg, p.o., b.i.d. for 7 days on and 7 days off; a total of 6 cycles \[1 cycle = 4 weeks\] starting Week 2 after cryoablation and going to Week 26)

Biological: VDC2008; Drug: Cyclophosphamide

Interventions

VDC2008 BIOLOGICAL

Intratumoral injection of VDC2008 post-cryotherapy. Dosage will depend on cohort: 2.5 x 10\^7, 7.5 x 10\^7 or 1.0 x 10\^8 cells

Also known as: Autologous dendritic cells

VDC2008

Cyclophosphamide DRUG

Cyclophosphamide i.v. given at day -3 (dose: 300mg/m2); Low-dose Cyclophosphamide pill given twice daily (dose: 25 mg, p.o., b.i.d. for 7 days on and 7 days off; a total of 6 cycles \[1 cycle = 4 weeks\] starting Week 2 after cryoablation and going to Week 26)

VDC2008

Eligibility Criteria

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

You may qualify if:

• Men ≥ 18 years of age and any race.
• Signed Informed Consent document obtained prior to the initiation of screening procedures.
• Histologically documented primary adenocarcinoma of the prostate. A specimen of the primary tumor must be submitted to the Central Pathology Laboratory for confirmation of prostatic adenocarcinoma and determination of Gleason Sum grading.
• Prior history of:
• Androgen Deprivation Therapy; or
• Organ-preserving therapy (i.e., non-prostatectomy) for primary prostate cancer (e.g., radiation therapy).
• In case of recurrence, subject must have evidence of prostate cancer by a positive biopsy revealing adenocarcinoma within the past 6 months of screening and confirmed by the Central Pathology Laboratory.
• TxNxM1a and/or TxNxM1b disease limited to three total metastatic sites as evidenced by lymph node metastases and /or bone metastases at time of screening.
• TxNxM1a : Lymph node metastases histologically proven and confirmed by Central Pathology Laboratory;
• TxNxM1a: Lymph node metastases not histologically proven, given that the following are satisfied in the temporal order listed:
• Computed tomography (CT) or Magnetic Resonance Imaging (MRI) for positive lymph nodes negative at original diagnosis of prostate cancer;
• Definitive local treatment undertaken;
• Evidence of local treatment failure on the basis of rising serum PSA;
• Prostatic biopsy positive for carcinoma;
• Subsequent CT or MRI reveals lymph node(s) of 2 cm diameter or greater

You may not qualify if:

• The presence of lung, liver or brain metastases, malignant pleural effusions or malignant ascites.
• Moderate or severe symptomatic metastatic disease. Subjects who meet either of the following criteria must be excluded:
• A requirement for treatment with opioid analgesics for any reason within 21 days prior to study screening;
• Average weekly pain score of 4 or more as reported on the 11-point Pain Intensity - Numerical Rating Scale (Appendix III) over the two weeks prior to study enrollment.
• Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2 accessed at study screening visit.
• Chemotherapy treatment at any time prior to study screening.
• Radiation therapy for metastatic disease, including intravenous radioactive strontium therapy.
• Initiation or discontinuation of bisphosphonate therapy within 28 days prior to study screening. Subjects taking bisphosphonate medication must not have their dosing regimen altered until objective disease progression is independently confirmed.
• Treatment with any of the following medications or interventions within 28 days of study screening:
• Systemic corticosteroids (use of inhaled, intranasal and topical steroids is acceptable);
• External beam radiation therapy or surgery;
• PC-SPES (or PC-SPEC) or Saw Palmetto extract;
• Megestrol acetate (Megace®), diethyl stilbesterol (DES), or cyproterone acetate;
• Ketoconazole;
• High dose calcitriol (i.e., \> 7.0 μg/week);

Sponsors & Collaborators

• Bostwick Laboratories: lead
• Prostate Institute of America: collaborator
• Community Memorial HealthCenter: collaborator
• HemaCare Corporation: collaborator

Study Sites (1)

Community Memorial Hospital

Ventura, California, 93003, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Dr. Duke K. Bahn
• Organization: Prostate Institute of America

DKBahn@CMHhospital.org

888-234-0004

Study Officials

• Duke K Bahn, M.D.

  Prostate Institue of America

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2008
• First Posted: September 16, 2008
• Study Start: August 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 4, 2014
• Results First Posted: November 4, 2014

Record last verified: 2014-11

Locations

US (1)