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AzTrials

Prostate CancerPhase 1NCT01174199

Temsirolimus and Vorinostat in Treating Patients With Metastatic Prostate Cancer

A Phase 1 study testing vorinostat, temsirolimus and laboratory biomarker analysis in people with Prostate Cancer and Adenocarcinoma of the Prostate, run by Roswell Park Cancer Institute at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RATIONALE: Temsirolimus and vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving temsirolimus together with vorinostat may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
vorinostat, temsirolimus and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
2 sitesUnited States
Study dates
Feb 2012to Aug 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have a histologically confirmed diagnosis of adenocarcinoma of the prostate that is hormone refractory and with evidence of progressive metastatic disease following docetaxel treatment by any of the following:
  • Increased serum prostate-specific antigen (PSA) levels confirmed by 3 consecutive PSA measurements (at least 2 weeks apart), the first sample to be taken at least 6 weeks after bicalutamide or megestrol acetate withdrawal AND/OR
  • Progression of bidimensionally measurable soft tissue (nodal) metastasis by CT scan or MRI within the past 4 weeks AND/OR
  • Progression of bone disease by at least two new bone lesions on bone scan confirmed by a second bone scan
  • Patients should be without persisting >= grade 2 hematological/non-hematological toxicities from previous treatments that would preclude evaluation of toxic effects of study treatment.Grade 1 residual toxicity will be acceptable. Patients should be off prior therapies at least 4 weeks before starting study treatment
  • Prior palliative radiation to metastatic lesion(s) is permitted, provided there is at least one measurable and/or evaluable lesion(s) that has not been radiated
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  • Castrate levels of serum testosterone (=< 50 ng/dL or 1.0 mmol/L) confirmed within two weeks prior to Day 1 of treatment. Testosterone levels will not be required for patients who have had bilateral orchiectomy
  • ECOG performance status 0-1
  • Life expectancy of greater than 6 months
  • Absolute neutrophil count >= 1,500/mm^3
  • Platelets >= 100,000/mm^3
  • Hgb >= 9g/L
  • Total bilirubin =< 1.5 x laboratory upper limit of normal (ULN)
  • AST(SGOT)/ALT(SGPT) <= 2.5 x laboratory ULN
  • Creatinine =< 1.5 x laboratory ULN or calculated creatinine clearance >= 50 ml/min
  • Serum amylase =< ULN (If > ULN, confirm pancreatic amylase < 1.1 ukat/L and serum lipase < ULN)
  • PT/INR <= 1.5
  • Urine protein < 1+ or if >= 1 then 24-hour urine protein should be obtained and should be < 1000 mg
  • Serum cholesterol < ULN with or without treatment for hyperlipidemia; if > ULN and untreated, may be rescreened for eligibility after treatment
  • Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of temsirolimus will be determined following review of their case by the Principal Investigator
  • Patients, if sexually active, will agree to use adequate contraceptive methods (barrier contraceptive with spermicide, vasectomy, abstinence) prior to study entry and for the duration of study participation
  • Ability to understand and the willingness to sign a written informed consent document
  • No evidence (>= 5 years) of prior malignancies except successfully treated basal cell or squamous cell carcinoma of the skin

Who cannot join

  • Prior use of HDAC or mTOR inhibitors
  • Patients with known brain metastases
  • Any medical condition, including the presence of laboratory abnormalities, which confounds the ability to interpret data from the study or places the patient at unacceptable risk if he participates in the study
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat or temsirolimus
  • Concurrent use of other anticancer agents or treatments except LHRH antagonists
  • Uncontrolled intercurrent illness including, but not limited to the following:(a)Ongoing or active infection including viral hepatitis,(b)Symptomatic congestive heart failure (New York Association Class II, III, or IV),(c) unstable angina pectoris requiring nitrate therapy,(d) prior myocardial infarction,(e)severe uncontrolled ventricular cardiac arrhythmias,(f) uncontrolled hypertension (defined as blood pressure of > 160 mmHg systolic and/or > 90 mmHg diastolic on medication),(g)electrocardiographic evidence of acute ischemia(h)Psychiatric illness/social situations that would limit compliance with study requirements
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  • Known positive serology for HIV and known history of HIV because of the potential for pharmacokinetic unforeseen toxicity and morbidity in an immunocompromised patient
  • Any treatment modalities, including radiation and surgery, not discontinued at least 4 weeks prior to treatment in this study
  • Chronic Hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver or history of chronic virus hepatitis or known viral hepatitis carrier (patient recovered from Hepatitis A will be allowed to enter the study)
  • Simultaneous participation in any other study involving investigational drugs or having participated in a study less than 4 weeks prior to treatment in this study
  • No investigational or commercial agents or therapies other than those described in the study may be administered with the intent to treat the patient's malignancy

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • The Sydney Kimmel Comprehensive Center at John Hopkins

    Baltimore, Maryland, 21287

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

Other trials in United States

About this study

Official title: A Phase I Study of the mTOR Inhibitor Temsirolimus in Combination With the HDAC Inhibitor Vorinostat in Patients With Metastatic Prostate Cancer

RATIONALE: Temsirolimus and vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving temsirolimus together with vorinostat may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of temsirolimus and vorinostat in treating patients with metastatic prostate cancer.

Read the detailed description

PRIMARY OBJECTIVES: I. To determine the safety, tolerability and recommended Phase II dose of temsirolimus in combination with vorinostat in patients with metastatic, hormone refractory, chemoresistant prostate cancer. II. To obtain preliminary evidence of response in prostate cancer patients treated with temsirolimus and vorinostat. SECONDARY OBJECTIVES: I. To determine the partial and complete objective response rates in metastatic hormone-refractory, chemo-resistant prostate cancer patients with measurable disease treated with temsirolimus and vorinostat. II. To determine the progression free survival and overall survival in patients with metastatic hormone refractory, chemo-resistant prostate cancer. III. To determine the PSA response, the duration of PSA response, time to PSA progression, PSA doubling time and PSA slope in metastatic hormone refractory, chemo-resistant prostate cancer patients treated with temsirolimus and vorinostat. IV. To assess changes in expression levels of bone remodeling markers (N telopeptides and bone alkaline phosphatase) and angiogenesis-related gene and protein expression (VEGF/HIF1-alpha) in blood and circulating tumor cells, and when available, in tissue, and correlate them with cancer and treatment related outcomes. V. To assess the changes in tumor metabolism with FDG/IIC-Choline PET/CT scan. OUTLINE: Patients receive oral vorinostat once daily on days 1-14 and temsirolimus IV on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days and then every 3 months thereafter.

Being tested
vorinostat, temsirolimus, laboratory biomarker analysis, positron emission tomography/computed tomography
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vorinostatDrug

    Also called L-001079038, SAHA, suberoylanilide hydroxamic acid, Zolinza

    Given orally

  • temsirolimusDrug

    Also called CCI-779, cell cycle inhibitor 779, rapamycin analog CCI-779, Torisel

    Given IV

  • laboratory biomarker analysisOther

    Correlative study

  • positron emission tomography/computed tomographyProcedure or surgery

    PET scan

Study groups in NCT01174199
Study groupRoleWhat they receive
Arm IExperimentalPatients receive oral vorinostat once daily on days 1-14 and temsirolimus IV on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: vorinostat; Drug: temsirolimus; Other: laboratory biomarker analysis; Procedure: positron emission tomography/computed tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequencies of DLT and toxicity

    Measured: 4 yrs

  2. Adverse events

    Measured: 4 years

Secondary outcomes (4)

  1. Median survival, median progression-free survival, and frequency of deaths

    Measured: 4 years

  2. PSA response

    Measured: Every 2 cycles of treatment

  3. Changes in expression of bone remodeling markers and angiogenesis-related gene and protein expression

    Measured: Prior to each cycle

  4. Changes in tumor metabolism as assessed by PET/CT scan

    Measured: Prior to each cycle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2010 (estimated)
  2. Study startFeb 2012
  3. Primary completionAug 2015
  4. Study completionAug 2016

Why it stopped: no value in finding efficacy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01174199
Sponsor's protocol ID
RPCI I 150709
Other IDs
NCI-2009-01537
Status last verified
Sep 2022
First submitted
30 Jul 2010
Last updated
3 Oct 2022
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing vorinostat, temsirolimus and laboratory biomarker analysis in people with Prostate Cancer and Adenocarcinoma of the Prostate, run by Roswell Park Cancer Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: no value in finding efficacy). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequencies of DLT and toxicity (time frame: 4 yrs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01174199.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.

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