A Phase I Study to Evaluate Safety, Tolerability in Adults With Lymphoma

NCT00538096 | Withdrawn Phase 1

• 1 other identifier: MI-CP137
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

• Evaluate the safety and tolerability of multiple doses of MEDI-538 by continuous IV infusion for 4 or 8 weeks in adult patients with B-cell NHL not eligible for curative therapy.
• Determine the maximum tolerated dose of MEDI-538 administered by continuous IV infusion.

Conditions

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Keywords

B-cell Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• All endpoints will be analyzed descriptively. AEs and SAEs will be summarized by dose cohort, body system, severity, and relationship to MEDI-538 through 30 days after discontinuation of MEDI-538.

  30 days after discontinuation of MEDI-538

Secondary Outcomes (1)

• The secondary endpoints of this study include measurement of the pharmacokinetics,immunogenicity, and antitumor activity of MEDI-538 in this patient population.

Study Arms (3)

1

EXPERIMENTAL

MEDI-538

Drug: MEDI-538

2

EXPERIMENTAL

MEDI-538

Drug: MEDI-538

3

EXPERIMENTAL

MEDI-538

Drug: MEDI-538

Interventions

MEDI-538 DRUG

1 of 3 target doses of MEDI-538 (5,μg/m2/24h) as a continuous IV infusion through a central line catheter. The initial treatment period will be 4 weeks in duration (Study Days 0-27), unless the patient discontinues treatment.

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult men or women at least 18 years of age;
• Written informed consent and Heath Insurance Portability and Accountability Act (HIPAA) authorization (applies to covered entities in the US only) obtained from the patient prior to performing any study-related procedures, including screening visits;
• Histologically confirmed B-cell NHL of one of the following classifications:
• Follicular lymphoma
• Marginal zone lymphoma;
• Lymphoplasmocytic lymphoma; or
• Mantle cell lymphoma.
• Not eligible for curative therapy according to the NCCN guidelines for NHL (NCCN 2006);
• Measurable disease (at least one lesion ≥ 20 mm in one dimension) documented by computed tomography (CT) scan;
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix A);
• Life expectancy of at least 6 months;
• Heterosexual sexually active females, unless surgically sterile or at least 1 year postmenopausal, must use an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 21 days prior to the first dose of study drug, and must agree to continue using such precautions through 3 months after the last dose of MEDI-538. Cessation of birth control after this point should be discussed with a responsible physician. Heterosexual sexually active males, unless surgically sterile, must likewise use an effective method of birth control (condom) and must agree to continue using such precautions through 3 months after the last dose of MEDI-538;
• Hemoglobin ≥ 10.0 g/dL; absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L; platelets ≥ 100.0 × 10\^9/L; lymphocyte count ≥ 0.8 × 10\^9/L; leukocyte count ≥ 3.0 × 10\^9/L; and D-dimer ≤ 2.5 × upper limit of normal (ULN); and antithrombin III ≥ lower limit of normal (LLN); and 10. Total bilirubin ≤ 1.5 × ULN; aspartate transaminase (AST), alanine transaminase (ALT), amylase and lipase ≤ 2 × ULN; serum creatinine ≤ 2 × ULN, and creatinine clearance ≥ 50 mL/min.

You may not qualify if:

• Receipt of MEDI-538 in any previous clinical study;
• History of allergy or reaction to any component of the MEDI-538 formulation;
• History of malignancy other than B-cell NHL within 5 years prior to study entry, with the exception of basal cell carcinoma of the skin or carcinoma in situ of the cervix successfully treated with curative therapy;
• Known or suspected CNS involvement by NHL;
• Clinical history of significant CNS pathology, eg, multiple occurrences of confusion, dementia, multiple previous infarcts, or major brain surgery;
• Active infection or known bacteremia. Patients with documented evidence of culture positive sepsis or active infection requiring IV antibiotic therapy must complete a full course of antibiotic treatment with no clinical or laboratory evidence of bacterial infection at least 2 weeks prior to starting therapy with MEDI-538.
• Vaccination (either preventive or therapeutic for infectious disease or cancer) within 2 weeks prior to initiation of study drug;
• Infection with human immunodeficiency virus (HIV-1 or HIV-2), chronic infection with hepatitis B or C, or acute infection with hepatitis A;
• History of primary immunodeficiency;
• History of serious, chronic autoimmune disease, eg, rheumatoid arthritis, systemic lupus erythematosus, and multiple sclerosis;
• Elective surgery planned during the study period through 30 days after discontinuation of MEDI-538;
• Autologous stem cell transplantation within 26 weeks prior to study entry;
• Allogenic stem cell transplantation or any other solid organ transplant;
• Cancer chemotherapy within 6 weeks prior to study entry;
• Radiotherapy within 6 weeks prior to study entry;

Sponsors & Collaborators

• MedImmune LLC: lead

MeSH Terms

Conditions

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Karen L. Kaucic, M.D.

  MedImmune LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 28, 2007
• First Posted: October 2, 2007
• Study Start: September 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2010
• Last Updated: September 5, 2008

Record last verified: 2008-09