Temsirolimus in Myelodysplastic Syndrome (MDS)

NCT01111448

Last updated date
Study Location
Klinikum Chemnitz Klinik für Innere Medizin III
Chemnitz, , 09113, Germany
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Myelodysplastic Syndrome
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Age >18 years at the time of signing the informed consent form;

- Patients able to understand the consequences of participating in this trial and not having any disorders or other circumstances (i.e. being in ward or imprisoned) which keeps them from giving written informed consent;

- cytologically or histologically established diagnosis of de novo or therapy-related MDS according to the FAB-classification, either previously treated or untreated, presenting with:

- Group I (low-risk): Low- or INT-1 risk features according to IPSS and requiring at least 4 units of red blood cells within the last 8 weeks prior to screening visit or presenting with neutropenia (<1 Gpt/l neutrophils) or

- Group II (high-risk): INT-2 or HIGH-risk IPSS refractory or intolerant to 5-Azacytidine.

CMML patients of dysplastic phenotype (WBC < 13 Gpt/l) may be included in both arms according to IPSS. CMML patients showing proliferative phenotype (WBC >=13 Gpt/l) will be included in the high risk arm;

- not eligible for an immediate allogeneic HSCT or conventional chemotherapy;

- all previous MDS specific therapies (except supportive approaches like transfusions or antibiotics) must have been discontinued at least 4 weeks prior to study enrollment;

- ECOG performance status of <= 3 at study entry;

- laboratory test results within these ranges:

- Serum creatinine <= 177 µmo/l (<= 2.0 mg/dL);

- total bilirubin <= 3 x ULN;

- AST (SGOT) and ALT (SGPT) <= 3 x ULN;

- total fasting cholesterol <= 9.1 mmol/l (350 mg/dl);

- fasting triglyceride level <= 4.5 mmol/l (400 mg/dl);

- platelets > 25 Gpt/l without transfusion support in patients with LOW- and INT-1 Risk according to IPSS;

- signed informed consent.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- For Patients with LOW- or INT1-Risk according to IPSS: Thrombocytopenia below 25 Gpt/l
(INT2- and HIGH-IPSS patients may be included irrespective of platelet count);


- known hypersensitivity to temsirolimus, sirolimus or any components of the infusion
solution (dl-alpha-tocopherol, propylene glycol, anhydrous citric acid, polysorbate
80, polyethylene glycol 400, dehydrated alcohol);


- known hypersensitivity to macrolid antibiotics (because of structural similarities
between this class of antibiotics and study medication);


- any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study;


- known positive for HIV or any other uncontrolled infection;


- presence of any other malignancy being not in complete remission for at least 3 years
(previous chemotherapy for other malignancies is not an exclusion criteria);


- necessity of therapeutic anticoagulation (excluding low dose ASS);


- participation in an other clinical trial within the last 4 weeks;


- pregnant or breast feeding females (lactating females must agree not to breast feed
while on study);


- females of childbearing potential (FCBP) except those fulfilling at least one of the
following criteria:


- post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with
serum FSH > 40 U/ml);


- post-surgery (6 weeks after bilateral ovarectomy with or without
hysterectomy);regular and correct use of contraceptives with a PEARL Index of <
1% (e.g. implants, depot formulations of hormones, oral contraceptives, intra
uterine device - IUD);


- sexual abstinence;


- partner, who had vasectomy (confirmed by two negative analyses of semen);


- male patients, who do not agree to use a latex condom during sexual contact with
females of childbearing potential while participating in the study and for at least 3
months following discontinuation from the study even if he has undergone a successful
vasectomy;


- patients with a history of chronic drug abuse or another illness which does not allow
the patient to assess the nature and/or possible consequences of the study;


- patients who are not likely to follow the trial protocol (lack of willingness to
cooperate).

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Myelodysplastic SyndromeTemsirolimus in Myelodysplastic Syndrome (MDS)
NCT01111448
  1. Chemnitz,
  2. Dresden,
  3. Düsseldorf,
  4. Goettingen,
  5. Leipzig,
  6. Leipzig,
  7. Mannheim,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Temsirolimus in Myelodysplastic Syndrome (MDS)
Official Title  ICMJE Treatment of MDS Patients With Single Agent Temsirolimus - a Pilot Study
Brief Summary The goal of this Pilot-study is to evaluate the response of unselected MDS patients to temsirolimus a drug approved for the treatment of renal cell cancer. It is planned to give temsirolimus at a weekly dose of 25 mg as intravenous infusion for a maximum duration of 12 months. Regular bone marrow biopsies are planned for controlling MDS response.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myelodysplastic Syndrome
Intervention  ICMJE Drug: Temsirolimus
25 mg/day 1; 8; 15; 22 of each 28-day cycle as intravenous infusion over 30 min
Study Arms  ICMJE Experimental: Temsirolimus
25 mg/day 1; 8; 15; 22 of each 28-day cycle
Intervention: Drug: Temsirolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 12, 2015)
20
Original Estimated Enrollment  ICMJE
 (submitted: April 26, 2010)
40
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age >18 years at the time of signing the informed consent form;
  • Patients able to understand the consequences of participating in this trial and not having any disorders or other circumstances (i.e. being in ward or imprisoned) which keeps them from giving written informed consent;
  • cytologically or histologically established diagnosis of de novo or therapy-related MDS according to the FAB-classification, either previously treated or untreated, presenting with:

    • Group I (low-risk): Low- or INT-1 risk features according to IPSS and requiring at least 4 units of red blood cells within the last 8 weeks prior to screening visit or presenting with neutropenia (<1 Gpt/l neutrophils) or
    • Group II (high-risk): INT-2 or HIGH-risk IPSS refractory or intolerant to 5-Azacytidine.

CMML patients of dysplastic phenotype (WBC < 13 Gpt/l) may be included in both arms according to IPSS. CMML patients showing proliferative phenotype (WBC >=13 Gpt/l) will be included in the high risk arm;

  • not eligible for an immediate allogeneic HSCT or conventional chemotherapy;
  • all previous MDS specific therapies (except supportive approaches like transfusions or antibiotics) must have been discontinued at least 4 weeks prior to study enrollment;
  • ECOG performance status of <= 3 at study entry;
  • laboratory test results within these ranges:

    • Serum creatinine <= 177 µmo/l (<= 2.0 mg/dL);
    • total bilirubin <= 3 x ULN;
    • AST (SGOT) and ALT (SGPT) <= 3 x ULN;
    • total fasting cholesterol <= 9.1 mmol/l (350 mg/dl);
    • fasting triglyceride level <= 4.5 mmol/l (400 mg/dl);
    • platelets > 25 Gpt/l without transfusion support in patients with LOW- and INT-1 Risk according to IPSS;
  • signed informed consent.

Exclusion Criteria:

  • For Patients with LOW- or INT1-Risk according to IPSS: Thrombocytopenia below 25 Gpt/l (INT2- and HIGH-IPSS patients may be included irrespective of platelet count);
  • known hypersensitivity to temsirolimus, sirolimus or any components of the infusion solution (dl-alpha-tocopherol, propylene glycol, anhydrous citric acid, polysorbate 80, polyethylene glycol 400, dehydrated alcohol);
  • known hypersensitivity to macrolid antibiotics (because of structural similarities between this class of antibiotics and study medication);
  • any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study;
  • known positive for HIV or any other uncontrolled infection;
  • presence of any other malignancy being not in complete remission for at least 3 years (previous chemotherapy for other malignancies is not an exclusion criteria);
  • necessity of therapeutic anticoagulation (excluding low dose ASS);
  • participation in an other clinical trial within the last 4 weeks;
  • pregnant or breast feeding females (lactating females must agree not to breast feed while on study);
  • females of childbearing potential (FCBP) except those fulfilling at least one of the following criteria:

    • post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with serum FSH > 40 U/ml);
    • post-surgery (6 weeks after bilateral ovarectomy with or without hysterectomy);regular and correct use of contraceptives with a PEARL Index of < 1% (e.g. implants, depot formulations of hormones, oral contraceptives, intra uterine device - IUD);
    • sexual abstinence;
    • partner, who had vasectomy (confirmed by two negative analyses of semen);
  • male patients, who do not agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 3 months following discontinuation from the study even if he has undergone a successful vasectomy;
  • patients with a history of chronic drug abuse or another illness which does not allow the patient to assess the nature and/or possible consequences of the study;
  • patients who are not likely to follow the trial protocol (lack of willingness to cooperate).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01111448
Other Study ID Numbers  ICMJE TUD-TEMDS1-042
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Technische Universität Dresden
Study Sponsor  ICMJE Technische Universität Dresden
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Uwe Platzbecker, MD, PhDMedizinische Klinik I, Universitätsklinikum Carl-Gustav-Carus, Dresden, Germany
PRS Account Technische Universität Dresden
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP