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Safety and Dose Study of GRN163L Administered Weekly to Treat Patients With Refractory or Relapsed Multiple Myeloma
This study is currently recruiting participants.
Verified by Geron Corporation, January 2009
Sponsored by: Geron Corporation
Information provided by: Geron Corporation
ClinicalTrials.gov Identifier: NCT00594126
  Purpose

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


Condition Intervention Phase
Multiple Myeloma
Drug: GRN163L
Phase I

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Multiple Myeloma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title: A Phase 1 Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of Weekly Administration of GRN163L in Patients With Refractory or Relapsed Multiple Myeloma

Further study details as provided by Geron Corporation:

Primary Outcome Measures:
  • Safety and MTD [ Time Frame: First 3 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK, PD, and efficacy [ Time Frame: Baseline to end of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: November 2007
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
3+3 cohort dose escalation
Drug: GRN163L
25% dose escalation infused over 2 hours weekly

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594126

Contacts
Contact: Catherine Howard, BSN 650-566-7221 choward@geron.com

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21231
Contact: Dionne Savage, RN     410-614-0382     dsavage3@jhmi.edu    
Principal Investigator: Carol A Huff, MD            
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Nikhil Munshi, MD     617-632-4218        
Principal Investigator: Nikhil Munshi, MD            
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Debbie Manfredi     716-845-3824     debbie.manfredi@RoswellPark.org    
Principal Investigator: Asher Chanan-Khan, MD            
Sponsors and Collaborators
Geron Corporation
Investigators
Study Chair: Laurence Elias, MD Geron Corporation
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Geron Corporation ( Laurence Elias, MD )
Study ID Numbers: GRN163L CP14A004
Study First Received: January 3, 2008
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00594126  
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board

Keywords provided by Geron Corporation:
Myeloma
Multiple Myeloma
Relapsed Multiple Myeloma
Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma

Study placed in the following topic categories:
Immunoproliferative Disorders
Hemorrhagic Disorders
Multiple myeloma
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Lymphoproliferative Disorders
Hemostatic Disorders
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009