A Study of Peripheral Blood Progenitor Cells Mobilisation (PBPC) With VTP195183 Plus Granulocyte-Colony Stimulating Factor (G-CSF) Compared to Mobilisation With G-CSF Alone - Full Text View

Purpose

Hematopoietic stem cells (HSC) are used to support the administration of high dose chemotherapy for a range of human cancers. For a safe HSC transplantation, a minimum of 5 million HSC per kilogram are required. HSC are collected from the bone marrow by using drugs such as G-CSF (filgrastim) which 'mobilize' them from the bone marrow into the bloodstream. HSC are collected from the bloodstream using an apheresis machine. Between 5 and 60% of patients fail to mobilize the minimum HSC dose required for safe transplantation, and this trial is investigating a way to enhance mobilization to overcome this problem. This trial aims to determine if a new vitamin A derivative is capable of enhancing HSC mobilization when used in conjunction with G-CSF. Patients will undergo two mobilization procedures. They will be given G-CSF alone, or a combination of the study drug plus G-CSF, and their stem cells will be collected. A comparison group of patients will be given G-CSF alone for both mobilizations. Stem cells collected from patients in this trial will be frozen and stored until they are required for transplantation into that patient. At that time, patients will be monitored for how well they recover from their high dose chemotherapy and HSC transplantation.

Condition	Intervention	Phase
Multiple Myeloma Lymphoma	Drug: VTP195183	Phase I Phase II

Genetics Home Reference related topics:

aceruloplasminemia hemophilia

MedlinePlus related topics:

Cancer Lymphoma Multiple Myeloma

ChemIDplus related topics:

Sargramostim Granulocyte-macrophage colony-stimulating factor Granulocyte colony-stimulating factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Official Title:	A Phase I/II Study of Peripheral Blood Progenitor Cells Mobilisation With VTP195183 Plus G-CSF Compared to Mobilisation With G-CSF Alone in Patients With Multiple Myeloma and Lymphoma.

Further study details as provided by Peter MacCallum Cancer Centre, Australia:

Primary Outcome Measures:

The primary objectives of this study are to determine:
PBPC yield using the Retinoic Acid Receptor alpha (RARα) agonist VTP195183 plus G-CSF
PB CD34+ kinetics using VTP195183 plus G-CSF
PB CFU (colony) counts using VTP195183 plus G-CSF
Peripheral blood neutrophil protease levels using VTP195183 plus G-CSF
The engraftment potential of human PBPC mobilized with VTP195183 plus G-CSF in a NOD-SCID/β2m-/- mouse model

Secondary Outcome Measures:

The secondary objectives of this study are to determine:
The toxicity of VTP195183 pretreatment when used with G-CSF
The engraftment potential in the clinical transplant setting of autologous VTP195183 plus G-CSF mobilized PBPC after high dose chemotherapy for multiple myeloma and lymphoma (part 2)

Estimated Enrollment:	30
Study Start Date:	October 2005

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18-70
Histologically proven multiple myeloma or lymphoma
Intent of treating physician to proceed to high dose therapy and autologous transplantation
Not currently receiving thalidomide (within 1 week of commencing VTP195813 or G-CSF), cytotoxic agents or high dose prednisolone or Dexamethasone (at doses greater than 15 mg prednisolone or equivalent per day)
Multiple myeloma patients must be taking regular bisphosphonate therapy
Absolute neutrophil count between 1.5 and 10 x 109/L
ECOG performance status ? 2
Life expectancy of at least 2 months
Written informed consent signed by patient or legally authorized representative

Exclusion Criteria:

Active infection or a fever > 38.2 degrees C (fever due to B symptoms in lymphoma patients will not exclude a patient)
Use within the previous 30 days of other vitamin A preparations within the last 30 days (including oral vitamin supplements, oral retinoids for acne or other skin disorders, bexarotene, or topical vitamin A preparations)
Pregnancy or breast feeding. Women of child-bearing potential, admitted to the trial must take adequate measures to prevent conception (at least two different forms of contraception during the study and for at least one month after completion of study drugs) and are to undergo a pregnancy test
Significant non-malignant disease including HIV infection, uncontrolled hypertension (diastolic blood pressures > 115 mmHg), unstable angina
Known allergy to E.coli-derived products
Current treatment with tetracycline antibiotics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234169

Locations


Australia, Victoria
	Peter MacCallum Cancer centre
	Melbourne, Victoria, Australia, 3002

Sponsors and Collaborators

Peter MacCallum Cancer Centre, Australia

The Leukaemia and Lymphoma Society

Investigators


Principal Investigator:	Kirsten Herbert, MBBS	Peter MacCallum Cancer Centre, Australia

More Information

Study ID Numbers:	05/09
First Received:	October 4, 2005
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00234169
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Peter MacCallum Cancer Centre, Australia:

Multiple Myeloma

Lymphoma

Study placed in the following topic categories:

Immunoproliferative Disorders

Blood Protein Disorders

Hematologic Diseases

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Hemostatic Disorders

Multiple Myeloma

Lymphatic Diseases

Hemorrhagic Disorders

Multiple myeloma

Lymphoproliferative Disorders

Lymphoma

Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immune System Diseases

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 17, 2008

Sponsors and Collaborators:	Peter MacCallum Cancer Centre, Australia The Leukaemia and Lymphoma Society
Information provided by:	Peter MacCallum Cancer Centre, Australia
ClinicalTrials.gov Identifier:	NCT00234169