Clinical trial NCT00234169: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Lymphoma
Keywords: Multiple Myeloma
Lymphoma
Lead sponsor: Peter MacCallum Cancer Centre, Australia
Sponsor class: OTHER
Collaborators: name: The Leukemia and Lymphoma Society
First posted: 2005-10-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: PB CD34+ kinetics using VTP195183 plus G-CSF
timeFrame: up to 28 days post study drug administration
Secondary outcomes:
measure: The toxicity of VTP195183 pretreatment when used with G-CSF
timeFrame: within 28 days of study drug administration
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer centre
state: Victoria
Study officials:
affiliation: Peter MacCallum Cancer Centre, Australia
name: Kirsten Herbert, MBBS
role: PRINCIPAL_INVESTIGATOR
References: