Temsirolimus in Recurrent Primary Central Nervous System (CNS) Lymphoma

Charité University Medicine Berlin

Status and phase

Unknown

Phase 2

Conditions

Recurrent or Refractory Primary CNS Lymphoma

Treatments

Drug: temsirolimus

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00942747

TemPCNSL

EudraCT 2009-011277-33

Details and patient eligibility

About

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.

Enrollment

37 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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