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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

This study has been completed.
Sponsor:
Collaborator:
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Kirsten Herbert, Peter MacCallum Cancer Centre, Australia
ClinicalTrials.gov Identifier:
NCT00234169
First received: October 4, 2005
Last updated: May 9, 2012
Last verified: May 2012

October 4, 2005
May 9, 2012
October 2005
January 2008   (final data collection date for primary outcome measure)
PB CD34+ kinetics using VTP195183 plus G-CSF [ Time Frame: up to 28 days post study drug administration ] [ Designated as safety issue: No ]
  • 2. PB CD34+ kinetics using VTP195183 plus G-CSF
  • The primary objectives of this study are to determine:
  • 1. PBPC yield using the Retinoic Acid Receptor alpha (RARα) agonist VTP195183 plus G-CSF
  • 3. PB CFU (colony) counts using VTP195183 plus G-CSF
  • 4. peripheral blood neutrophil protease levels using VTP195183 plus G-CSF
  • 5. The engraftment potential of human PBPC mobilized with VTP195183 plus G-CSF in a NOD-SCID/β2m-/- mouse model
Complete list of historical versions of study NCT00234169 on ClinicalTrials.gov Archive Site
The toxicity of VTP195183 pretreatment when used with G-CSF [ Time Frame: within 28 days of study drug administration ] [ Designated as safety issue: Yes ]
  • The secondary objectives of this study are to determine:
  • 1. The toxicity of VTP195183 pretreatment when used with G-CSF
  • 2. 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)
Not Provided
Not Provided
 
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
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.

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Multiple Myeloma
  • Lymphoma
Drug: VTP195183

VTP195183: 60mg/m2 orally daily G-CSF: 10mcg/kg/day subcutaneously Provision is made for dose reduction of VTP195183 in the event of unexpected dose-limiting toxicities G-CSF10mcg/kg/day will commence on day 1 and will continue until the peripheral blood (PB) CD34+ count falls below baseline, or below 5 x 106/L, whichever happens first.

Patients will be treated with VTP195183 alone at 60mg/m2/day from day 1 to day 7. On day 8 VTP195183 will be continued and G-CSF10mcg/kg/day will be added. VTP195183 plus G-CSF will continue until the peripheral blood (PB) CD34+ count falls below baseline, or below 5 x 106/L, whichever happens first.

Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 18-70
  2. Histologically proven multiple myeloma or lymphoma
  3. Intent of treating physician to proceed to high dose therapy and autologous transplantation
  4. 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)
  5. Multiple myeloma patients must be taking regular bisphosphonate therapy
  6. Absolute neutrophil count between 1.5 and 10 x 109/L
  7. ECOG performance status ? 2
  8. Life expectancy of at least 2 months
  9. Written informed consent signed by patient or legally authorized representative

Exclusion Criteria:

  1. Active infection or a fever > 38.2 degrees C (fever due to B symptoms in lymphoma patients will not exclude a patient)
  2. 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)
  3. 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
  4. Significant non-malignant disease including HIV infection, uncontrolled hypertension (diastolic blood pressures > 115 mmHg), unstable angina
  5. Known allergy to E.coli-derived products
  6. Current treatment with tetracycline antibiotics
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00234169
05/09
Yes
Kirsten Herbert, Peter MacCallum Cancer Centre, Australia
Peter MacCallum Cancer Centre, Australia
The Leukemia and Lymphoma Society
Principal Investigator: Kirsten Herbert, MBBS Peter MacCallum Cancer Centre, Australia
Peter MacCallum Cancer Centre, Australia
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP