NCT00400556

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 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 multiple-myeloma

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_1 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2006

Completed
Last Updated

November 17, 2006

Status Verified

November 1, 2006

First QC Date

November 15, 2006

Last Update Submit

November 15, 2006

Conditions

Multiple MyelomaCutaneous Lymphoma

Keywords

mobilizationATRAG-CSFfilgrastimretinoidsstem cell mobilizationhematopoietic stem and progenitor cells

Outcome Measures

Primary Outcomes (14)

  • Toxicity data (NCI-CTC version 2.0 criteria)

  • skin toxicity

  • hepatotoxicity

  • mucosal toxicity

  • hematologic toxicity

  • neurologic toxicity

  • treatment response

  • CD34+ cell count peak level

  • time to CD34+ count peak level

  • time to reach level >5 x 10^6.L

  • area under curve for duration of time spent with CD34+ count >5 x 10^6/L

  • peripheral blood colony forming unit assays

  • peak CFU-GEMM level

  • time to peak CFU-GEMM level

Interventions

ATRA plus G-CSF (filgrastim, NEUPOGEN (R)) combinationDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peter MacCallum Cancer Center

East Melbourne, Victoria, 3002, Australia

Location

Related Publications (1)

  • Herbert KE, Walkley CR, Winkler IG, Hendy J, Olsen GH, Yuan YD, Chandraratna RA, Prince HM, Levesque JP, Purton LE. Granulocyte colony-stimulating factor and an RARalpha specific agonist, VTP195183, synergize to enhance the mobilization of hematopoietic progenitor cells. Transplantation. 2007 Feb 27;83(4):375-84. doi: 10.1097/01.tp.0000251376.75347.b4.

    PMID: 17318068BACKGROUND

MeSH Terms

Conditions

Multiple MyelomaLymphoma, T-Cell, Cutaneous

Interventions

TretinoinGranulocyte Colony-Stimulating FactorFilgrastim

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphoma, Non-HodgkinLymphomaLymphatic Diseases

Intervention Hierarchy (Ancestors)

Vitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological FactorsColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteins

Study Officials

  • Kirsten E Herbert, MBBS

    Peter MacCallum Cancer Center

    PRINCIPAL INVESTIGATOR

  • Miles Prince, MBBS

    Peter MacCallum Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2006

First Posted

November 17, 2006

Study Start

March 1, 2005

Study Completion

May 1, 2005

Last Updated

November 17, 2006

Record last verified: 2006-11

Locations

AU(1)