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

NCT00234169 | Completed Phase 1 DMC

• 1 other identifier: 05/09
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Myeloma; Lymphoma

Keywords

Multiple Myeloma; Lymphoma

Outcome Measures

Primary Outcomes (1)

• PB CD34+ kinetics using VTP195183 plus G-CSF

  up to 28 days post study drug administration

Secondary Outcomes (1)

• The toxicity of VTP195183 pretreatment when used with G-CSF

  within 28 days of study drug administration

Interventions

VTP195183 DRUG

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 Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peter MacCallum Cancer Centre, Australia: lead
• The Leukemia and Lymphoma Society: collaborator

Study Sites (1)

Peter MacCallum Cancer centre

Melbourne, Victoria, 3002, Australia

Location

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphatic Diseases

Study Officials

• Kirsten Herbert, MBBS

  Peter MacCallum Cancer Centre, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 4, 2005
• First Posted: October 6, 2005
• Study Start: October 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: May 10, 2012

Record last verified: 2012-05

Locations

AU (1)