Safety and Dose Study of GRN163L Administered Weekly to Treat Patients With Refractory or Relapsed Multiple Myeloma - Full Text View

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:	December 2008
Estimated Primary Completion Date:	December 2008 (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: Liza Melchor	650 473-8671	fmelchor@geron.com

Locations


United States, Florida
	H. Lee Moffitt Cancer Center and Research Institute	Withdrawn
	Tampa, Florida, United States, 33612

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: Dawn DePaolo, RN, BSN, CCRP 716 845-3824 dawnmarie.depaolo@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
First Received:	January 3, 2008
Last Updated:	August 4, 2008
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 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

Blood Protein Disorders

Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 29, 2008

Sponsored by:	Geron Corporation
Information provided by:	Geron Corporation
ClinicalTrials.gov Identifier:	NCT00594126