Prostatic NeoplasmPhase 2NCT00001446
A Randomized Phase II Study of Oral Thalidomide in Patients With Hormone-Refractory Prostate Cancer
A Phase 2 study testing thalidomide in people with Prostatic Neoplasm, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This is a phase II study designed to evaluate the potential clinical efficacy of thalidomide in patients with hormone-refractory prostate cancer. An important aspect of this study is to characterize the pharmacokinetics of thalidomide, as well as make correlations between the degree of angiogenesis occurring in a… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Neoplasm
- What is being tested?
- thalidomide
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1995to Jul 2001
- Phase
- Phase 2
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
Histologically documented adenocarcinoma of the prostate. Confirmation by the Clinical Center Pathology Department required.
CT-defined soft tissue disease required for staging if prostate-specific antigen (PSA) less than 20 ng/mL.
Progressive hormone-refractory disease for 1 month prior to entry (and after withdrawal of any antiandrogens), documented by at least one of the following: 3 consecutive rising levels of PSA at least 1 week apart. 1 measurement at least 50% greater than PSA nadir after last therapy.
New bone metastasis on Tc-99 bone scintigraphy.
Progression of measurable or evaluable soft-tissue metastases.
Development of new area of disease. 25% increase in previously measured lesions.
Total androgen ablation required. Testosterone in castrate range.
Concurrent luteinizing hormone-releasing hormone (LHRH) agonist required if not surgically castrated.
No prior prostate irradiation or radical prostatectomy unless other biopsiable lesions available.
Urgent local problems corrected prior to entry (e.g., severe bone pain, spinal cord compression, urinary flow obstruction).
No brain metastases.
PRIOR/CONCURRENT THERAPY:
Thyroid replaced concurrent to start of study for patients with chemical hypothyroidism.
Thyroid replaced prior to study for patients with clinical hypothyroidism.
Biologic Therapy: At least 4 weeks since Biologic Therapy and recovered from all toxic effects.
Chemotherapy:
No prior suramin.
At least 4 weeks since chemotherapy and recovered from all toxic effects.
Endocrine Therapy:
See Disease Characteristics.
At least 4 weeks since hormonal therapy except LHRH agonist therapy.
Radiotherapy:
See Disease Characteristics.
At least 4 weeks since radiotherapy (6 weeks since strontium).
Surgery: See Disease Characteristics.
PATIENT CHARACTERISTICS:
Age: 18 and over.
Performance status: ECOG 0-2.
Life expectancy: More than 3 months.
Hematopoietic:
Absolute granulocyte count greater than 1,000/mm(3).
Platelet count greater than 75,000/mm(3).
Hemoglobin greater than 8.0 g/dL (transfusion allowed if requirement maintained for more than 30 days OR bleeding identified and treated).
Hepatic:
Bilirubin no greater than 1.5 times normal.
AST and ALT less than 2.5 times normal.
Renal:
Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance greater than 40 mL/min.
Proteinuria no greater than 2+ OR less than 500 mg/24 hr (except patients with ureteral stents).
BUN normal.
Electrolytes normal.
Urinalysis normal.
Cardiovascular:
No unstable or newly diagnosed angina.
No myocardial infarction within 6 months.
No NYHA class II-IV congestive heart failure.
Pulmonary:
No chronic obstructive lung disease requiring oxygen therapy.
Neurologic:
No clinically detectable peripheral neuropathy greater than grade 1.
No seizures within 10 years.
No anticonvulsants.
No requirement for sedatives or hypnotics.
OTHER:
Normal thyroid function tests at least 4 weeks prior to study and throughout study.
No concurrent anticoagulants.
No active infection.
Off antibiotics at least 1 week.
Ureteral stent or Foley catheter allowed with no antibiotics.
HIV negative.
No concurrent life-threatening illness.
No concurrent malignancies.
Ability to travel to the National Institutes of Health.
Adequate contraception required of sexually active patients and their partners during and for 2 months after therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
This is a phase II study designed to evaluate the potential clinical efficacy of thalidomide in patients with hormone-refractory prostate cancer.
An important aspect of this study is to characterize the pharmacokinetics of thalidomide, as well as make correlations between the degree of angiogenesis occurring in a patient and the activity of thalidomide.
Read the detailed description
This is a phase II study designed to evaluate the potential clinical efficacy of thalidomide in patients with hormone-refractory prostate cancer. Patients will be randomized to two different treatment arms (low dose versus high dose). An important aspect of this study is to characterize the pharmacokinetics of thalidomide, as well as make correlations between the degree of angiogenesis occurring in a patient and the activity of thalidomide. Each patient that has biopsiable lesions will undergo a pretreatment biopsy of their prostate (or other site of soft tissue disease) and repeat after 2 to 6 months of treatment. Additional information will be obtained on the changes in the circulating levels of the following growth factors: bFGF, TNF, VEGF, and TGFB. Neurological complications are the primary dose-limiting toxicity anticipated with chronic thalidomide administration.
- Conditions
- Prostatic Neoplasm
- Being tested
- thalidomide
- Keywords
- Angiogenesis, Malignancy, Neuropathy, Pharmacokinetics, Sedation
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thalidomideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startSep 1995
- Study completionJul 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Enrolment
- 64 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001446
- Sponsor's protocol ID
- 950178
- Other IDs
- 95-C-0178
- Status last verified
- Aug 2000
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Bakay B, Nyhan WL. Binding of thalidomide by macromolecules in the fetal and maternal rat. J Pharmacol Exp Ther. 1968 Jun;161(2):348-60. No abstract available.
PubMed 5652850Barnhill RL, McDougall AC. Thalidomide: use and possible mode of action in reactional lepromatous leprosy and in various other conditions. J Am Acad Dermatol. 1982 Sep;7(3):317-23. doi: 10.1016/s0190-9622(82)70118-5.
PubMed 7130490Sissung TM, Danesi R, Kirkland CT, Baum CE, Ockers SB, Stein EV, Venzon D, Price DK, Figg WD. Estrogen receptor alpha and aromatase polymorphisms affect risk, prognosis, and therapeutic outcome in men with castration-resistant prostate cancer treated with docetaxel-based therapy. J Clin Endocrinol Metab. 2011 Feb;96(2):E368-72. doi: 10.1210/jc.2010-2070. Epub 2010 Nov 24.
PubMed 21106711
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Oral Thalidomide in Patients With Hormone-Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT00001446
- Acronym / sponsor ID
- 950178
- Conditions
- Prostatic Neoplasm
- Keywords
- Angiogenesis, Malignancy, Neuropathy, Pharmacokinetics, Sedation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Sep 1995
- Study completion
- Jul 2001
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II study designed to evaluate the potential clinical efficacy of thalidomide in patients with hormone-refractory prostate cancer.
An important aspect of this study is to characterize the pharmacokinetics of thalidomide, as well as make correlations between the degree of angiogenesis occurring in a patient and the activity of thalidomide.
Detailed description
This is a phase II study designed to evaluate the potential clinical efficacy of thalidomide in patients with hormone-refractory prostate cancer. Patients will be randomized to two different treatment arms (low dose versus high dose). An important aspect of this study is to characterize the pharmacokinetics of thalidomide, as well as make correlations between the degree of angiogenesis occurring in a patient and the activity of thalidomide. Each patient that has biopsiable lesions will undergo a pretreatment biopsy of their prostate (or other site of soft tissue disease) and repeat after 2 to 6 months of treatment. Additional information will be obtained on the changes in the circulating levels of the following growth factors: bFGF, TNF, VEGF, and TGFB. Neurological complications are the primary dose-limiting toxicity anticipated with chronic thalidomide administration.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thalidomide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 5652850Bakay B, Nyhan WL. Binding of thalidomide by macromolecules in the fetal and maternal rat. J Pharmacol Exp Ther. 1968 Jun;161(2):348-60. No abstract available.
- Background: PubMed 7130490Barnhill RL, McDougall AC. Thalidomide: use and possible mode of action in reactional lepromatous leprosy and in various other conditions. J Am Acad Dermatol. 1982 Sep;7(3):317-23. doi: 10.1016/s0190-9622(82)70118-5.
- Derived from this study: PubMed 21106711Sissung TM, Danesi R, Kirkland CT, Baum CE, Ockers SB, Stein EV, Venzon D, Price DK, Figg WD. Estrogen receptor alpha and aromatase polymorphisms affect risk, prognosis, and therapeutic outcome in men with castration-resistant prostate cancer treated with docetaxel-based therapy. J Clin Endocrinol Metab. 2011 Feb;96(2):E368-72. doi: 10.1210/jc.2010-2070. Epub 2010 Nov 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing thalidomide in people with Prostatic Neoplasm, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001446, which also lists 3 linked publications.
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 4 Mar 2008.