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Sargramostim After Cryotherapy in Treating Patients With Prostate Cancer

Information source: University of Colorado, Denver
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer

Intervention: cryotherapy (Procedure); sargramostim (Biological)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: University of Colorado, Denver

Official(s) and/or principal investigator(s):
Al Barqawi, Principal Investigator, Affiliation: University of Colorado, Denver

Overall contact:
Tracey MacDermott, Phone: 303-724-2757, Email: tracey.macdermott@ucdenver.edu

Summary

This randomized pilot phase I trial studies how well sargramostim after cryotherapy works in treating patients with prostate cancer. Biological therapies, such as sargramostim, use substances made from living organisms that may stimulate the immune system in different ways and stop tumor cells from growing. Cryosurgery, also known as cryotherapy, kills tumor cells by freezing them. Giving sargramostim after cryotherapy may work better in treating prostate cancer.

Clinical Details

Official title: The Immuno-Response to Primary Cryotherapy for the Treatment of Prostate Cancer

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Changes in B cell response identified by Serametrix assay

Change in T cell responses identified by Intracellular cytokine assay and enzyme-linked immunospot

Secondary outcome: PSA levels in serum samples

Detailed description: PRIMARY OBJECTIVES: I. Determine an unknown normal immune response (T cell and B cell) to post-cryotherapy treatment for prostate cancer. II. Detect the altered immune response (T cell and B cell) post-GM-CSF (sargramostim) response and post-cryotherapy for the prostate cancer. Patients are randomized to 1 of 2 treatment arms. ARM I (TREATMENT): Patients undergo cryotherapy on day 0 and receive sargramostim subcutaneously (SC) on days 1, 3, 5, 8, 10, and 12. ARM II (CONTROL): Patients undergo cryotherapy on day 0. After completion of study treatment, patients are followed up for 6 months.

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Patients diagnosed with prostate cancer that elect to undergo primary cryotherapy of

the prostate

- Patients who are diagnosed with clinical stage T1a -T2c prostate cancer

- Gleason score sum of less than or equal to 7 (3+4)

- Prostate-specific antigen (PSA) < 20 ng/dl

- Patient will read, understand and sign the informed consent and Health Insurance

Portability and Accountability Act (HIPAA) agreement

- Patients must have a life expectancy of at least one year

Exclusion Criteria:

- Known hypersensitivity to granulocyte macrophage colony stimulating factor (GM-CSF)

or yeast

- Anticipated blood donation within the next 90 days

- Magnetic resonance imaging (MRI), computed tomography (CT) and bone scan evidence of

metastatic prostate cancer regardless the PSA level; (the indication for which is clinically driven and at the discretion of the treating physician)

- Any history of current or within the past 48 hours of acute or chronic bacterial,

fungal or viral infectious disease

- Documented excessive leukemic myeloid blasts in the bone marrow or peripheral blood

(>= 10%) in the past 6 months

- Previous organ transplant

- Immunosuppression including primary, secondary, iatrogenic and idiopathic

- Other serious diseases (hematological, hepatic, renal, respiratory, central nervous

system, autoimmune or psychiatric)

- Enrollment in other studies for any disease in the past 30 days

- Diagnosis of cancer that in not considered cured, except basal cell carcinoma (BCC)

of skin

- Prior transurethral resection of the prostate with a large tissue defect (at the

discretion of the investigator)

- History of abdominoperineal resection for rectal cancer, rectal stenosis, or other

major rectal pathology

- Patient currently receiving lithium, steroid, chemotherapy or radiotherapy treatment

Locations and Contacts

Tracey MacDermott, Phone: 303-724-2757, Email: tracey.macdermott@ucdenver.edu

University of Colorado Cancer Center, Aurora, Colorado 80045, United States; Not yet recruiting
Al Barqawi, Phone: 303-724-2722, Email: Al.Barqawi@ucdenver.edu
Al Barqawi, Principal Investigator
Additional Information

Starting date: December 2015
Last updated: June 16, 2015

Page last updated: August 23, 2015

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