Lenalidomide and Cyclophosphamide in Treating Patients With Previously Treated Hormone-Refractory Prostate Cancer

NCT01093183 | Terminated Phase 1 Results DMC

• 4 other identifiers: 0479-09-FBNCI-2010-00363479-09P30CA036727
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I/II trial studies the side effects and best dose of lenalidomide when given together with cyclophosphamide and to see how well they work in treating patients with previously treated hormone-refractory prostate cancer. Lenalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving lenalidomide together with cyclophosphamide may kill more tumor cells.

Conditions

Adenocarcinoma of the Prostate; Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose of Lenalidomide Administered in Combination With Oral Cyclophosphamide (Phase I)

  Defined to be the dose cohort below which 2 of 3 or 3 of 6 patients experience dose-limiting toxicities in course 1 or the highest dose cohort of 25 mg.

  28 days

Secondary Outcomes (4)

• Number of Patients Achieving Objective PSA Response (50% Decrease in PSA Levels Sustained for at Least 4 Weeks) as Defined by PSA Working Group Criteria

  4 weeks

• Anti-tumor Activity as Assessed by the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD)

  Up to 4 months

• Proportion of Patients Achieving CR

  At 4 months

• Overall Survival

  Up to 4 years

Study Arms (1)

Treatment (lenalidomide and cyclophosphamide)

EXPERIMENTAL

Patients receive lenalidomide PO QD on days 1-21 and cyclophosphamide PO QD on days 1-28. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.

Drug: lenalidomide; Drug: cyclophosphamide; Other: laboratory biomarker analysis; Other: questionnaire administration; Other: quality-of-life assessment

Interventions

lenalidomide DRUG

Given PO

Also known as: CC-5013, IMiD-1, Revlimid

Treatment (lenalidomide and cyclophosphamide)

cyclophosphamide DRUG

Given PO

Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana

Treatment (lenalidomide and cyclophosphamide)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (lenalidomide and cyclophosphamide)

questionnaire administration OTHER

Ancillary studies

Treatment (lenalidomide and cyclophosphamide)

quality-of-life assessment OTHER

Ancillary studies

Also known as: quality of life assessment

Treatment (lenalidomide and cyclophosphamide)

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written informed consent
• Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
• Men with histologically documented previously treated hormone refractory adenocarcinoma of the prostate; mixed histology and rare subtypes histology of prostate cancer are allowed only in phase 1 portion of trial
• Patients must be on an luteinizing-hormone-releasing hormone (LHRH) agonist or have undergone surgical castration
• Patients must have already failed or progressed after treatment with a docetaxel-based regimen; patients who were unable to tolerate docetaxel are eligible in phase 1 portion of trial
• Creatinine clearance \>= 45 by Cockcroft-Gault formula
• Total bilirubin =\< upper limit of normal (ULN)
• Aspartate aminotransferase (AST) \< 2 x ULN
• Alanine aminotransferase (ALT) \< 2 x ULN
• Hepatic alkaline phosphatase \< 2 x ULN (\< 5.0 x ULN for subjects with known bone metastases)
• Absolute neutrophil count greater than 1,500/mm\^3
• Platelets greater than 100,000/mm\^3
• Hemoglobin \>= 9.0 g/dL
• Able to adhere to the study visit schedule and other protocol requirements
• No serious disease or condition that, in the opinion of the investigator, would compromise the patient's ability to participate in the study

You may not qualify if:

• Treatment with a cytotoxic chemotherapy or investigational drug within 30 days before day 1 of study treatment; palliative radiation therapy is allowed, as long as a radiated lesion is not used to assess response rate, and the radiation occurred greater than 4 weeks prior to enrollment
• Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type A, B or C or active hepatitis
• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
• Known hypersensitivity to thalidomide, lenalidomide or cyclophosphamide
• Active infection at the start of lenalidomide
• Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; prior to study entry, any EKG abnormality at screening has to be documented by the investigator as not medically relevant
• History of life threatening or recurrent thrombosis/embolism; patients may participate if they are adequately anti-coagulated during the treatment
• Patient has \> grade 2 peripheral neuropathy within 14 days before enrollment
• Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
• Any unresolved chronic toxicity greater than Common Terminology Criteria (CTC) grade 2 from previous anticancer therapy (except alopecia)
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial

Sponsors & Collaborators

• University of Nebraska: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Lenalidomide; Cyclophosphamide

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)

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; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: James Schwarz, MD
• Organization: University of Nebraska Medical Center

jkschwarz@unmc.edu

402-559-5166

Study Officials

• James K Schwarz, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: March 24, 2010
• First Posted: March 25, 2010
• Study Start: March 4, 2010
• Primary Completion: May 19, 2015
• Study Completion: May 19, 2015
• Last Updated: September 13, 2023
• Results First Posted: June 11, 2018

Record last verified: 2023-08

Locations

US (1)