Lenalidomide and GM-CSF in Treating Patients With Prostate Cancer

NCT00939510 | Completed Phase 1 Results DMC

• 4 other identifiers: CASE3805P30CA043703IRB# 8121RV-PCA-PI-059
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Lenalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. GM-CSF may stimulate the immune system in different ways and stop tumor cells from growing. Giving lenalidomide together with GM-CSF may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide when given together with GM-CSF and to see how well it works in treating patients with prostate cancer.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; hormone-resistant prostate cancer; recurrent prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (2)

• Number of Patients With a PSA Response

  Number of patients with a PSA Response defined as a PSA decline greater or equal to 50% compared with baseline value.

  reevaluated for response every eight weeks

• RECIST-defined Measurable Disease

  Patients who have a response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) by RECIST criteria. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of SD, follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6-8 weeks

  every 8 weeks and at end of treatment

Secondary Outcomes (1)

• Number of Patients With Statistically Significant Change in Immune Response From Baseline to End of Study

  every 28 days for first 3 cycles, end of study

Study Arms (1)

Lenalidomide (RevlimidTM ) and GM-CSF

EXPERIMENTAL

Biological: sargramostim; Drug: lenalidomide; Other: laboratory biomarker analysis

Interventions

sargramostim BIOLOGICAL

All patients will receive GM-CSF at a dose of 250 mcg subcutaneously on Mondays, Wednesdays and Fridays every week. No dose escalation or de-escalations will be made to GM-CSF.

Also known as: GM-CSF

Lenalidomide (RevlimidTM ) and GM-CSF

lenalidomide DRUG

Lenalidomide will be administered at 25 mg/day orally on days 1-21 of a 28-day cycle. Initially 6 patients will be entered at the 25 mg/day level. If 0 or 1 patients have a dose limiting toxicity, then the 25 mg lenalidomide + GM-CSF 250 mcg subcutaneously on Mondays, Wednesdays and Fridays every week will be accepted as the phase II dose.

Lenalidomide (RevlimidTM ) and GM-CSF

laboratory biomarker analysis OTHER

Prior to the initiation of each cycle of therapy for the first 3 cycles, and at discontinuation from study blood will be collected for assessments of a prostate cancer specific immune response.

Lenalidomide (RevlimidTM ) and GM-CSF

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Androgen-independent disease * Testosterone ≤ 50 ng/mL * Is currently receiving luteinizing hormone-releasing hormone agonists as maintenance or has undergone prior orchiectomy for testosterone suppression * Progressive disease, as defined by ≥ 1 of the following: * Clinical or radiographic evidence of metastases that have progressed irrespective of PSA changes * Asymptomatic (non-opioid requiring) bone-only metastatic disease with a rising PSA on separate measurements ≥ 1 week apart * No symptomatic bone metastases * Biochemical progression (PSA-only disease), defined as having an absolute PSA value of ≥ 2.0 ng/mL on 3 separate measurements ≥ 2 weeks apart with a PSA doubling time of ≤ 10 months * No evidence of CNS (brain or leptomeningeal) metastases or pleural and/or pericardial effusions PATIENT CHARACTERISTICS: * ECOG performance status of 0-1 * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Serum creatinine ≤ 2.0 mg/dL * AST \< 3 times normal * Bilirubin \< 1.5 mg/dL * PT and PTT normal * Calcium normal * Fertile patients must use effective contraception during and for ≥ 28 days after completion of study therapy * Agrees to abstain from donating blood, semen, or sperm during and for ≥ 28 days after completion of study therapy * No pre-existing peripheral neuropathy \> grade 1 * No active unresolved infection * No known contraindication to lenalidomide or sargramostim * No other malignancies within the past 5 years, except for curatively treated basal cell or squamous cell carcinoma of the skin or stage Ta transitional cell carcinoma of the bladder PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy for metastatic prostate cancer * More than 1 year since prior adjuvant and/or neoadjuvant therapy * More than 4 weeks since prior flutamide (6 weeks for other antiandrogens) * No prior thalidomide or lenalidomide * At least 4 weeks since prior surgery or external-beam radiotherapy and recovered * At least 6 weeks since prior radiopharmaceutical therapy, including samarium-153 or strontium-89, and recovered * No initiation of bisphosphonate therapy within 1 month before and during study therapy * Patients on stable doses of bisphosphonates who show subsequent tumor progression may continue to receive bisphosphonates * Concurrent daily aspirin for the prevention of thrombotic events required * Patients intolerant to aspirin may receive low-dose warfarin as prophylaxis * No other concurrent investigational agents * No other concurrent anticancer therapy, including radiotherapy or thalidomide

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

Sponsors & Collaborators

• Robert Dreicer MD: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

sargramostim; Granulocyte-Macrophage Colony-Stimulating Factor; Lenalidomide

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

Results Point of Contact

• Title: Dr. Robert Dreicer
• Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

dreicer@ccf.org

216-445-4623

Study Officials

• Robert Dreicer, MD, FACP

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2009
• First Posted: July 15, 2009
• Study Start: July 1, 2005
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2012
• Last Updated: January 31, 2013
• Results First Posted: July 12, 2012

Record last verified: 2013-01

Locations

US (1)