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Temsirolimus in Recurrent Primary Central Nervous System (CNS) Lymphoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
PD Dr. Agnieszka Korfel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00942747
First received: July 20, 2009
Last updated: April 15, 2013
Last verified: April 2013
  Purpose
This is an open-label trial investigating the efficacy of temsirolimus in recurrent or refractory primary CNS lymphoma (PCNSL) after initial chemotherapy with a high-dose methotrexate containing regimen. 37 patients are planned to be treated with weekly infusions of 25mg Temsirolimus (first 3 patients) or 75mg Temsirolimus (all other patients) up to a maximum of 12 months. The trial is designed in two stages, if less than one of the first 12 patients responds to treatment, the trial is stopped. In addition to efficacy, safety and penetration of temsirolimus into the cerebrospinal fluid will be investigated.

Condition Intervention Phase
Recurrent or Refractory Primary CNS Lymphoma
Drug: temsirolimus
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Temsirolimus in Refractory and Recurrent Primary CNS Lymphoma

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: Weeks 4, 12, every 12 weeks thereafter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
  • Time to progression of disease [ Time Frame: Weeks 4, 12, every 12 weeks thereafter or upon clinical suspicion of disease progression ] [ Designated as safety issue: No ]
  • Penetration of temsirolimus into cerebrospinal fluid [ Time Frame: Weeks 1, 4 and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 37
Study Start Date: July 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Temsirolimus
Weekly IV temsirolimus
Drug: temsirolimus
Weekly infusion of 25mg Temsirolimus (first 3 patients) or 75mg Temsirolimus (all other patients) up to a maximum of 12 months in the case of continuing response to treatment
Other Names:
  • Torisel
  • CCI-770

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary CNS lymphoma diagnosed histologically or by cerebrospinal fluid cytology; absence of systemic lymphoma manifestations
  • Relapse or lymphoma progression after/during high-dose methotrexate containing first-line chemotherapy or alternative therapy in the case of contraindications against high-dose methotrexate
  • ECOG performance score ≤ 2
  • Age ≥18 years and ≤ 75 years
  • Life expectancy of at least 3 months
  • Absence of active infection
  • Negative HIV serology
  • Adequate renal function (GFR >30ml/h)
  • Adequate bone marrow reserve (neutrophils > 1500/µl, platelets > 80,000/µl)
  • Bilirubin <1.5x upper limit of normal (ULN), ALT and AST <3x ULN
  • At least 3 weeks interval from prior cytostatic treatment
  • Negative pregnancy test
  • Patient accessible for treatment and follow-up
  • Patient compliance
  • Signed informed consent

Exclusion Criteria:

  • Secondary CNS lymphoma
  • Primary intraocular lymphoma
  • Patient eligible for high-dose chemotherapy and autologous stem-cell transplantation
  • Concurrent treatment within another clinical trial
  • Concurrent other malignant disease
  • Symptomatic congestive heart failure (≥NYHA II)
  • Active or uncontrolled chronic infection
  • Severe concomitant disease incompatible with study conduct
  • History of cerebral bleeding
  • Concomitant treatment with strong CYP3A4/5-inductors or -inhibitors
  • Premenopausal women without highly effective contraception (defined as Pearl index <1)
  • Pregnant or lactating women
  • Refusal to record and pass on pseudonymized disease and treatment related data as part of the treatment protocol
  • Concurrent admission to a psychiatric institution by public order
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00942747

Locations
Germany
Charité Campus Benjamin Franklin
Berlin, Germany, 12200
Neurology, Knappschaftskrankenhaus Bochum, Bochum University
Bochum, Germany, 44892
Neurology, University Hospital Bonn
Bonn, Germany, 53127
Hematology, Klinikum Frankfurt/Oder
Frankfurt an der Oder, Germany, 15236
Hematology, University Hospital Heidelberg
Heidelberg, Germany, 69120
Klinikum Grosshadern, University Hospital Munich
Munich, Germany, 81377
Sponsors and Collaborators
Charite University, Berlin, Germany
Pfizer
Investigators
Principal Investigator: Agnieszka Korfel, MD Charite University, Berlin, Germany
  More Information

Publications:
Smith SM, Pro B, Cisneros A, Smith S, Stiff P, Lester E, Modi S, Dancey JE, Vokes EE, van Besien E. Activity of single agent temsirolimus (CCI-779) in non-mantle cell non-Hodgkin lymphoma subtypes. J Clin Oncol 2008:26 (May 20 suppl; abstr 8514).

Responsible Party: PD Dr. Agnieszka Korfel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00942747     History of Changes
Other Study ID Numbers: TemPCNSL  EudraCT 2009-011277-33 
Study First Received: July 20, 2009
Last Updated: April 15, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
temsirolimus, primary CNS lymphoma, PCNSL, salvage treatment

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents

ClinicalTrials.gov processed this record on December 08, 2016