Status:
COMPLETED
ATRA Plus G-CSF for Mobilization of Hematopoietic Stem and Progenitor Cells
Lead Sponsor:
Peter MacCallum Cancer Centre, Australia
Collaborating Sponsors:
The Leukemia and Lymphoma Society
Conditions:
Multiple Myeloma
Cutaneous Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
Hematopoietic stem and progenitor cells (HSPC) are used for transplantation in patients undergoing high dose therapy for the treatment of a range of cancers. * HSPC are collected from the bloodstream...
Detailed Description
HSPC mobilization is normally achieved using cytokines such as G-CSF, or occasionally GM-CSF, often in combination with myelosuppressive chemotherapy. Studies in the mouse model have shown that retin...
Eligibility Criteria
Inclusion
- likely to comply with study protocol
- age of 18-70
- histologically proven multiple myeloma or lymphoma
- not currently receiving cytotoxic agents however thalidomide, prednisolone, dexamethasone are allowable
- multiple myeloma patients must be receiving regular bisphosphonates
- absolute neutrophil count between 1.5 and 10.0 x 10\^9/L
- ECOG performance status \</= 3
- life expectancy of at least two months
- written informed consent signed by patient or legally authorised representative
Exclusion
- use of other vitamin A preparations within the last 30 days
- active infection or fever \>/= 38.2 degrees celsius
- 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) and are to undergo a pregnancy test. Oral contraception must not include low-dose progestogens
- known allergy to E.coli derived products
- current treatment with tetracycline antibiotics
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00400556
Start Date
March 1 2005
End Date
May 1 2005
Last Update
November 17 2006
Active Locations (1)
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1
Peter MacCallum Cancer Center
East Melbourne, Victoria, Australia, 3002