Status:
COMPLETED
Temsirolimus and Brentuximab Vedotin in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Adult Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial studies the side effects and best dose of temsirolimus when given together with brentuximab vedotin in treating patients with Hodgkin lymphoma that has returned or has not responded...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of temsirolimus in combination with brentuximab vedotin in patients with relapsed and refractory Hodgkin lymphoma. II. To assess the...
Eligibility Criteria
Inclusion
- Patients must have histologically confirmed cluster of differentiation (CD)30 positive relapsed or refractory Hodgkin lymphoma
- Measurable disease, defined as at least one lesion \> 1.5 cm, in the greatest transverse diameter
- Patients must have failed autologous stem cell transplant or at least 2 prior cytotoxic regimens for Hodgkin lymphoma
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
- Life expectancy of greater than 3 months
- Leukocytes \>= 3,000/mcL
- Absolute neutrophil count \>= 1,500/mcL
- Platelets \>= 100,000/mcL
- Total bilirubin within normal institutional limits or \< 3 x the upper limit of normal in patients with Gilbert's disease
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 × institutional upper limit of normal
- Creatinine =\< 1.5 x institutional upper limit of normal OR creatinine clearance \>= 40 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
- Patients must have no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \> 92% while breathing room air
- Patients must have forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) \> 60% by pulmonary function test (PFT), unless due to large mediastinal mass from Hodgkin's lymphoma (HL); carbon monoxide diffusion capacity (DLCO), FEV1, and FVC all \> 50% predicted value
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of temsirolimus and brentuximab vedotin administration
- Ability to understand and the willingness to sign a written informed consent document
- Fasting serum cholesterol =\< 300 mg/dL OR =\< 7.75 mmol/L AND fasting triglycerides =\< 2.5 x upper limit of normal (ULN); NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
- Patients with known human immunodeficiency virus (HIV) infection must have CD4 count greater than 200; anti-retroviral agents that induce or inhibit cytochrome P450 (CYP)3A4 activity are not allowed
Exclusion
- Patients who are eligible for autologous stem cell transplant unless they refuse to receive autologous stem cell transplant
- Patients who have had chemotherapy or radiotherapy within 3 weeks of registration or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier; Note: patients are considered enrolled on the study after protocol registration and not after signing consent
- Patients who have received brentuximab vedotin within 6 months of enrolling on the study
- Patients who are receiving any other investigational agents
- Patients with known cerebral or meningeal involvement by lymphoma should be excluded from this clinical trial
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to temsirolimus or brentuximab vedotin
- Patients receiving any medications or substances that are inhibitors or inducers of CYP3A4 are ineligible
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled diabetes, clinically significant pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with temsirolimus and brentuximab vedotin
- Previous primary progression or grade 3 toxicity on treatment with brentuximab vedotin
- Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent, except corticosteroids with a daily dosage equivalent to prednisone =\< 20 mg; topical or inhaled corticosteroids are allowed
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01902160
Start Date
September 1 2013
Last Update
November 9 2015
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065