search
Back to results

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

Primary Purpose

Multiple Myeloma, Lymphoma

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
VTP195183
Sponsored by
Peter MacCallum Cancer Centre, Australia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Lymphoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peter MacCallum Cancer centre

Outcomes

Primary Outcome Measures

PB CD34+ kinetics using VTP195183 plus G-CSF

Secondary Outcome Measures

The toxicity of VTP195183 pretreatment when used with G-CSF

Full Information

First Posted
October 4, 2005
Last Updated
May 9, 2012
Sponsor
Peter MacCallum Cancer Centre, Australia
Collaborators
The Leukemia and Lymphoma Society
search

1. Study Identification

Unique Protocol Identification Number
NCT00234169
Brief Title
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
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peter MacCallum Cancer Centre, Australia
Collaborators
The Leukemia and Lymphoma Society

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Lymphoma
Keywords
Multiple Myeloma, Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
VTP195183
Intervention Description
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.
Primary Outcome Measure Information:
Title
PB CD34+ kinetics using VTP195183 plus G-CSF
Time Frame
up to 28 days post study drug administration
Secondary Outcome Measure Information:
Title
The toxicity of VTP195183 pretreatment when used with G-CSF
Time Frame
within 28 days of study drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten Herbert, MBBS
Organizational Affiliation
Peter MacCallum Cancer Centre, Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peter MacCallum Cancer centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs