ATRA Plus G-CSF for Mobilization of Hematopoietic Stem and Progenitor Cells

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

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 after treatment with medications that cause the HSPC to move from the bone marrow into the bloodstream, a process called mobilization

• between 5 and 60% of patients can fail to collect enough HSPC for a transplant, using current mobilization techniques

• this study aims to assess the safety of combining a derivative of vitamin A, ATRA with G-CSF (the drug most commonly used to mobilize HSPC)

• ATRA has never been combined with G-CSF for mobilization of HSPC and therefore a study is needed to assess the safety of this combination, and whether it successfully mobilizes HSPC

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peter MacCallum Cancer Centre, Australia
• Collaborator: The Leukemia and Lymphoma Society
• Treatments: Lenograstim

Criteria

Inclusion Criteria:

• 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
• life expectancy of at least two months

• written informed consent signed by patient or legally authorised representative

Exclusion Criteria:

• 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