GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer

NCT00400517 | Completed Phase 2 Results

• 4 other identifiers: CASE-CCF-4643P30CA043703CELGENE-CASE-CCF-4643BRLX-CASE-CCF-4643
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Thalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. Giving GM-CSF and thalidomide before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving GM-CSF together with thalidomide works in treating patients undergoing surgery for high-risk prostate cancer.

Conditions

Prostate Cancer

Keywords

stage III prostate cancer; stage II prostate cancer; adenocarcinoma of the prostate; stage I prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (4)

• Proportion of Patients P0 at Surgery

  Pathologic Complete Response is defined as complete eradication of tumor.

  8 weeks

• Proportion of Patients With Negative Surgical Margins

  Presence or Absence of prostate cancer tissue at the sites of surgical resection. This is done by reviewing the entire specimen resected at the time or Radical Prostatectomy.

  8 Weeks

• Prostate-specific Antigen Response

  Number of subjects that achieved a PSA decline while on therapy. Any PSA decline while on treatment, compared with baseline PSA prior to study entry.

  8 weeks

• Time to Clinical Progression

  Time to progression. WIth a median follow up of 32 months (12-51 months), 5 of 26 patients developed biochemical failure.

  32 months

Study Arms (1)

GM-CSF Injections and Oral Thalidomide

EXPERIMENTAL

taught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and the daily oral medicine for up to 2 months if the therapy appears to be helping your disease.

Biological: sargramostim; Drug: thalidomide; Procedure: conventional surgery; Procedure: neoadjuvant therapy

Interventions

sargramostim BIOLOGICAL

administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day

Also known as: GM-CSF

GM-CSF Injections and Oral Thalidomide

thalidomide DRUG

doses up to 400 mg/day

Also known as: THALOMID

GM-CSF Injections and Oral Thalidomide

conventional surgery PROCEDURE

SOC care surgery

GM-CSF Injections and Oral Thalidomide

neoadjuvant therapy PROCEDURE

post radical prostatectomy

GM-CSF Injections and Oral Thalidomide

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 meeting any of the following criteria for high-risk disease: * Clinical stage II or III (T2b, T2c, or T3 with any grade or prostate-specific antigen \[PSA\]) * Gleason score 7 (4+3 only) or ≥ 8 (any stage or PSA) * Serum PSA ≥ 10 ng/dL (any grade or stage) * Any stage, PSA, or Gleason score with ≥ 35% chance of biochemical failure at 5 years based on Kattan's nomogram * No clinical evidence of CNS metastases * No metastatic disease as demonstrated by radiological exam (CT scan, MRI, bone scan, x-ray) within 8 weeks of study entry * Appropriate medical candidate for radical prostatectomy PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Creatinine ≤ 2.0 mg/dL * Granulocyte count ≥ 1,800/mm³ * Platelet count ≥ 100,000/mm³ * AST \< 3 times upper limit of normal * Bilirubin ≤ 1.5 mg/dL * Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment * No active unresolved infection * No pre-existing peripheral neuropathy \> grade 1 * No known HIV positivity * No other malignancy within the past 5 years except curatively treated basal cell or squamous cell carcinoma of the skin or controlled Ta transitional cell carcinoma of the bladder * No known contraindication to sargramostim (GM-CSF) or thalidomide PRIOR CONCURRENT THERAPY: * No prior radiotherapy to the prostate or pelvis * No prior chemotherapy or hormonal therapy for prostate cancer * No parenteral antibiotics within the past 7 days

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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

sargramostim; Granulocyte-Macrophage Colony-Stimulating Factor; Thalidomide; Neoadjuvant Therapy

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)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Combined Modality Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Jorge Garcia
• Organization: Cleveland Clinic

Garciaj4@ccf.org

2164447774

Study Officials

• Jorge Garcia, MD, FACP

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Eric Klein, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2006
• First Posted: November 17, 2006
• Study Start: March 1, 2003
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: August 28, 2018
• Results First Posted: August 28, 2018

Record last verified: 2018-07

Locations

US (1)