Ketoconazole, Hydrocortisone, and GM-CSF in Treating Patients With Progressive Prostate Cancer After Hormone Therapy

NCT00309894 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: 035516UCSF-H45860-23833-02
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as ketoconazole, may stop the adrenal glands from making androgens. GM-CSF may help ketoconazole work better by making tumor cells more sensitive to the drug. Giving ketoconazole together with hydrocortisone and GM-CSF may be an effective treatment for prostate cancer. PURPOSE: This phase II trial is studying how well giving ketoconazole together with hydrocortisone and GM-CSF works in treating patients with progressive prostate cancer after hormone therapy.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

• Time to progression

Secondary Outcomes (3)

• Response rate as measured by prostate-specific antigen and objective parameters

• Frequency of grades 3-4 toxicity

• Pattern of immune response as measured by immunohistochemistry

Interventions

sargramostim BIOLOGICAL

ketoconazole DRUG

therapeutic hydrocortisone DRUG

Eligibility Criteria

• Age: Up to 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Progressive disease after androgen deprivation AND meets 1 of the following criteria: * Measurable disease * Measurable lesions ≥ 10 mm with spiral CT * Up to 5 lesions per organ and 10 lesions total should be identified as target lesions * No measurable disease * Patients with prostate-specific antigen (PSA)-only disease must have an elevated PSA * PSA evidence for progressive disease consists of a PSA level of ≥ 5 ng/mL that has risen on ≥ 2 successive occasions, ≥ 2 weeks apart * Patients with a positive bone scan must also have an elevated PSA * Patients who received prior antiandrogen as a part of primary androgen ablation therapy must demonstrate disease progression after discontinuation of the antiandrogen * Disease progression after antiandrogen withdrawal is defined as 2 consecutive rising PSA values obtained ≥ 2 weeks apart, or documented osseous or soft tissue progression * Patients receiving flutamide must have had ≥ 1 of the PSA values obtained ≥ 4 weeks after flutamide discontinuation * Patients receiving bicalutamide or nilutamide must have had ≥ 1 of the PSA values obtained ≥ 6 weeks after antiandrogen discontinuation * Testosterone \< 50 ng/dL * PSA ≥ 5 ng/mL PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * No serious intercurrent infections or nonmalignant uncontrolled medical illnesses * No psychiatric illnesses OR social situations that would limit compliance * No active or uncontrolled autoimmune disease * ALT and AST normal * Bilirubin normal * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine ≤ 1.5 times upper limit or normal (ULN) * Hemoglobin ≥ 8 g/dL * No other currently active malignancy except for nonmelanoma skin cancer * No currently active malignancy defined as therapy completed with ≤ 30% risk of relapse PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Patients must continue primary androgen deprivation therapy with a luteinizing-hormone releasing-hormone (LHRH) analogue if they have not undergone orchiectomy * No prior systemic chemotherapy for prostate cancer * All other systemic chemotherapy must have been completed ≥ 2 years prior to study * No other concurrent chemotherapy, immunotherapy, or radiotherapy * Major surgery or radiation therapy completed ≥ 4 weeks prior to study * No other concurrent corticosteroids, including routine use antiemetics * No prior ketoconazole, aminoglutethimide, or corticosteroids for treatment of progressive prostate cancer * No prior immunotherapy (e.g., vaccines or sargramostim GM-CSF) * Patients receiving any other hormonal therapy (e.g., megestrol, finasteride, herbal product known to decrease PSA levels \[e.g., saw palmetto or PC-SPES\], or any systemic corticosteroid) must discontinue the agent ≥ 4 weeks prior to enrollment and progressive disease must be documented after discontinuation * No initiation of bisphosphonate therapy within 1 month prior to starting study therapy * Patients on stable doses that show tumor progression are allowed to continue bisphosphonate * No concurrent supplements or complementary medicines/botanicals, except any combination of the following: * Conventional multivitamin supplements * Selenium * Lycopene * Soy supplements * Vitamin E * At least 8 weeks since prior radiopharmaceuticals (strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium) * No other concurrent investigational or commercial anticancer agents or therapies

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Veterans Affairs Medical Center - San Francisco

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

sargramostim; Ketoconazole; Hydrocortisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Charles Ryan, MD

  University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2006
• First Posted: April 3, 2006
• Study Start: April 1, 2004
• Primary Completion: November 1, 2007
• Study Completion: December 1, 2007
• Last Updated: August 5, 2019

Record last verified: 2019-08

Locations

US (2)