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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00450619 |
Purpose
RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to tumor cells and not harm normal cells. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving samarium Sm 153 lexidronam pentasodium together with vaccine therapy and GM-CSF may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying samarium Sm 153 lexidronam pentasodium, vaccine therapy, and GM-CSF to see how well they work compared to samarium Sm 153 lexidronam pentasodium alone in treating patients with prostate cancer and bone metastases.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Cancer Pain Prostate Cancer |
Biological: recombinant fowlpox-TRICOM vaccine Biological: recombinant vaccinia-TRICOM vaccine Biological: sargramostim Radiation: samarium Sm 153 lexidronam pentasodium |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label |
| Official Title: | A Randomized Phase 2.5 Study of 153Sm-EDTMP (Quadramet) With or Without a PSA/TRICOM Vaccine in Men With Androgen-Insensitive Metastatic Prostate Cancer |
| Estimated Enrollment: | 68 |
| Study Start Date: | February 2007 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Experimental
Patients receive samarium Sm 153 lexidronam pentasodium IV over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
|
Radiation: samarium Sm 153 lexidronam pentasodium
Given IV
|
|
Arm II: Experimental
Patients receive recombinant vaccinia-TRICOM vaccine subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine SC on days 15 and 29 and sargramostim (GM-CSF)* (see outline) SC on days 1-4, 15-18, 29-32. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium as in arm I.
|
Biological: recombinant fowlpox-TRICOM vaccine
Given subcutaneously
Biological: recombinant vaccinia-TRICOM vaccine
Given subcutaneously
Biological: sargramostim
Given subcutaneously
Radiation: samarium Sm 153 lexidronam pentasodium
Given IV
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, randomized, open-label, pilot study. Patients are randomized to 1 of 2 treatment arms.
NOTE: *Patient no longer receive GM-CSF as of 3/4/09.
Some patients (only patients enrolled at The National Institutes of Health) who are HLA-A2-positive undergo apheresis for immunological studies. Blood serum is analyzed for interferon gamma-releasing T cells specific to prostate-specific antigen (PSA)-3A as measured by ELISPOT assay as well as antibodies to PSA, vaccinia, fowlpox, and antinuclear antibody titer**.
NOTE: **Antinuclear antibody titer no longer analyzed as of 3/4/2009.
Bone pain is assessed periodically.
After completion of study treatment, patients are followed periodically for up to 15 years.
PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
Metastatic androgen-insensitive disease
Progressive disease, defined by 1 of the following criteria:
PATIENT CHARACTERISTICS:
No evidence of being immunocompromised, including any of the following:
Concurrent use of topical steroids (including steroid eye drops) or systemic steroids
No history of any of the following:
No autoimmune diseases that require treatment, including any of the following:
No history of allergy or untoward reaction to prior vaccination with vaccinia virus or to any component of the vaccinia vaccine regimen
No concurrent serious medical illness (e.g., one that requires treatment) that would preclude study treatment including, but not limited to, any of the following:
No other acute, chronic, or exfoliative skin conditions, including any of the following:
Must be able to avoid close contact (e.g., share the same house or have close physical contact) with any of the following individuals for ≥ 3 weeks after treatment with the study vaccinia vaccine:
Individuals with other acute, chronic, or exfoliative skin conditions, including any of the following:
PRIOR CONCURRENT THERAPY:
No other concurrent therapy, including any of the following:
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
| Bethesda, Maryland, United States, 20892-1182 | |
| Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |
| Principal Investigator: | James L. Gulley, MD, PhD, FACP | National Cancer Institute (NCI) |
More Information
| Responsible Party: | Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School ( Robert S. DiPaola ) |
| Study ID Numbers: | CDR0000535561, NCI-07-C-0106 |
| Study First Received: | March 20, 2007 |
| Last Updated: | July 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00450619 History of Changes |
| Health Authority: | Unspecified |
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pain recurrent prostate cancer stage IV prostate cancer bone metastases pain |
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Genital Neoplasms, Male Prostatic Diseases Physiological Effects of Drugs Urogenital Neoplasms Genital Diseases, Male Pharmacologic Actions Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site |
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Samarium ethylenediaminetetramethylenephosphonate Neoplasm Metastasis Peripheral Nervous System Agents Analgesics Central Nervous System Agents Prostatic Neoplasms |