Clinical trial NCT00594126: Safety and Dose Study of GRN163L Administered to Treat Patients With Refractory or Relapsed Multiple Myeloma
Official title: A Phase 1 Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of GRN163L in Patients With Refractory or Relapsed Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: Myeloma
Multiple Myeloma
Relapsed Multiple Myeloma
Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma
Lead sponsor: Geron Corporation
Sponsor class: INDUSTRY
First posted: 2008-01-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and the maximum tolerated dose (MTD) of GRN163L when administered to patients with refractory or relapsed multiple myeloma.

Detailed description: GRN163L is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells. Inhibition of telomerase may result in antineoplastic effects.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of multiple myeloma (either secretory or nonsecretory disease)
* Relapsed or refractory disease
* At least two prior treatment regimens
* ECOG performance status 0-2
* Adequate hepatic/renal function and platelet count
* If previously treated with an anthracycline, anthracenedione, or trastuzumab, must have left ventricular ejection fraction \> 50%

Exclusion Criteria:

* Prior allogeneic bone marrow transplant, including syngeneic transplant
* Known intracranial disease or epidural disease
* Prior malignancy (within the last 3 years)
* Clinically significant cardiovascular disease or condition
* Active or chronically recurrent bleeding (eg, active peptic ulcer disease
* Prolongation of PT or aPTT \> the ULN or fibrinogen \< the LLN
* Clinically relevant active infection
* Serious co-morbid medical conditions, including cirrhosis and chronic obstructive or chronic restrictive pulmonary disease
* Symptomatic hyperviscosity syndrome
* Any other cancer therapy within 3 weeks prior to study, except for mitomycin C, nitrosoureas, or high-dose chemotherapy with stem cell support within 6 weeks prior to study
* Investigational therapy within 4 weeks prior to study
* Anti-platelet therapy within 2 weeks prior to study, other than low dose aspirin prophylaxis therapy and low dose heparin administration for management of IV access devices
* Radiation therapy within 4 weeks prior to study
* Major surgery within 4 weeks prior to study
* Active autoimmune disease requiring immunosuppressive therapy
* Known positive serology for HIV

Primary outcomes:
measure: Safety and MTD
timeFrame: First 3 weeks
Secondary outcomes:
measure: PK, PD, and efficacy
timeFrame: Baseline to end of treatment
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Geron Corporation
name: Steve Kelsey, MD
role: STUDY_DIRECTOR
References: