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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
History of Changes
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • PB CD34+ kinetics using VTP195183 plus G-CSF [ Time Frame: up to 28 days post study drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The toxicity of VTP195183 pretreatment when used with G-CSF [ Time Frame: within 28 days of study drug administration ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: October 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

  Eligibility

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

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
  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 Leukemia and Lymphoma Society
Investigators
Principal Investigator: Kirsten Herbert, MBBS Peter MacCallum Cancer Centre, Australia
  More Information

No publications provided

Responsible Party: Kirsten Herbert, Doctor, Peter MacCallum Cancer Centre, Australia
ClinicalTrials.gov Identifier: NCT00234169     History of Changes
Other Study ID Numbers: 05/09
Study First Received: October 4, 2005
Last Updated: May 9, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Peter MacCallum Cancer Centre, Australia:
Multiple Myeloma
Lymphoma

Additional relevant MeSH terms:
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
 Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013